← Back to search
COLORADO STATE UNIVERSITY
FORT COLLINS, CO, 80521
UnclaimedClaim this profile (free)
Prime contracting experience
31 records from government sources. Past participation is not evidence of current teaming interest.
| Role | Agency | Description | Vehicle | Obligated | Action date | Period |
|---|---|---|---|---|---|---|
| Prime | Department of Health and Human Services National Institutes of Health | PRE-CLINICAL MODELS OF INFECTIOUS DISEASES (PCMID) | 75N93024D00009USAspending | $748,244 | Sep 23, 2026 | Jul 15, 2024 – Jul 14, 2031 |
| Prime | Department of Health and Human Services National Institutes of Health | TESTING OF STANDARD DRUGS FOR MYCOBACTERIUM TUBERCULOSIS (MTB) IN ANIMAL MODELS FOR MTB | 75N93021D00014USAspending | $326,078 | Sep 9, 2026 | Aug 15, 2021 – Jun 14, 2022 |
| Prime | National Aeronautics and Space Administration National Aeronautics and Space Administration | DETERMINE THE EFFECTS OF RADIATION QUALITY, DOSE, AND DOSE RATE ON CANCER INITIATION, PROMOTION, AND PROGRESSION IN HS/NPT OUTBRED MICE. ESTABLISH RBES AND QUALITY FACTOR ESTIMATES FOR SPACE-RELEVANT RADIATION EXPOSURES. | — | $975,000 | Sep 2, 2026 | Jun 1, 2026 – May 31, 2030 |
| Prime | Department of Health and Human Services National Institutes of Health | PCMID - ESTABLISHMENT OF SMALL ANIMAL MODELS FOR SCREENING MCMS FOR THE 2019 NOVEL CORONAVIRUS (SARS-COV-2) | HHSN272201700018IUSAspending | $1,358,350 | Aug 27, 2026 | Mar 23, 2020 – Jan 31, 2023 |
| Prime | Department of Health and Human Services National Institutes of Health | COVID-19. TO DEVELOP AND MANUFACTURE AN INACTIVATED VIRUS VACCINE USING BLOOD PATHOGEN REDUCTION TECHNOLOGY. | — | $6,252,060 | Aug 3, 2026 | Sep 1, 2020 – Apr 30, 2028 |
| Prime | Department of Defense Department of the Army | ESTCP PROJECT RC25-8522 OPERATIONAL PICTURE ENVIRONMENT FOR RESOURCE MANAGEMENT (OPENRM) GIS PLATFORM FOR DOD | — | $250,000 | Jul 22, 2026 | Oct 23, 2025 – Oct 22, 2029 |
| Prime | Department of Defense Department of the Army | HYDRODYNAMIC MODELING OF HYDRAULIC STEEL STRUCTURES U437P00 | — | $469,840 | Jul 6, 2026 | Aug 15, 2024 – Aug 14, 2027 |
| Prime | Department of Defense Department of the Army | ER21-1019: A QUANTUM CHEMICAL - MACHINE LEARNING APPROACH FOR THE PREDICTION OF THERMAL PFAS DESTRUCTION | — | $553,061 | Jun 15, 2026 | Apr 15, 2022 – Apr 15, 2027 |
| Prime | Department of Defense Department of the Navy | COOPERATIVE INSTITUTE FOR RESEARCH IN THE ATMOSPHERE (CIRA) OPTICAL VARIABILITY EVALUATION OF REGIONAL CLOUD ASYMMETRIES IN SPACE AND TIME (OVERCAST) | — | $3,891,000 | May 28, 2026 | Aug 6, 2024 – Aug 6, 2029 |
| Prime | Department of the Interior Bureau of Land Management | NV LOTIC AIM DATA COLLECTION 2026 | — | $296,495 | Apr 23, 2026 | Sep 23, 2025 – Nov 30, 2026 |
| Prime | Department of Defense Department of the Army | FIELD COLLECTION AND MONITORING OF ENDANGERED HAWAIIAN COOT AND HAWAIIAN GALLINULE ON THE MCBH, KANEOHE BAY RALC U433F60 | — | $307,582 | Nov 24, 2025 | Mar 14, 2022 – Dec 31, 2024 |
| Prime | Department of Defense Department of the Army | BAA 21-0030, ADVANCED SIMULATIONS AND UNCERTAINTY QUANTIFICATIONS OF THE RESPONSE OF MILITARY STRUCTURES TO BLAST LOADING | — | $350,000 | Sep 23, 2025 | Sep 29, 2021 – Dec 31, 2026 |
| Prime | Department of the Interior Bureau of Land Management | CONTRACTOR SHALL PROVIDE ALL RESOURCES (LABOR, TRAVEL, EQUIPMENT, MATERIALS, TRAINING, AND INCIDENTALS) NEEDED TO PERFORM RIPARIAN AND WETLAND ASSESSMENT, INVENTORY, AND MONITORING (AIM) DATA COLLECTION SERVICES THROUGHOUT THE STATE OF WYOMING IN ACC | — | $351,599 | Sep 4, 2025 | Sep 25, 2024 – Sep 30, 2029 |
| Prime | Department of the Interior Bureau of Land Management | CONTRACTOR SHALL PROVIDE ALL RESOURCES (LABOR, TRAVEL, EQUIPMENT, MATERIALS, TRAINING, AND INCENDTALS) TO PERFORM RIPARIAN AND WETLAND ASSESSMENT, INVENTORY, AND MONITORING DATA COLLECTION THROUGHOUT THE STATE OF WYOMING | — | $362,010 | Sep 3, 2025 | Sep 25, 2024 – Sep 30, 2029 |
| Prime | Department of Health and Human Services Centers for Disease Control and Prevention | VETERINARY CARE OF LABORATORY ANIMALS | — | $256,542 | Aug 19, 2025 | Jul 22, 2022 – Dec 7, 2025 |
| Prime | Department of Defense Department of the Army | BAA 24-0034 IMPROVED CHARACTERIZATION OF GROUNDWATER RESOURCES IN TRANSBOUNDARY WATERSHEDS USING SATELLITE DATA AND INTEGRATED MODELS | — | $2,000,099 | May 8, 2025 | May 15, 2025 – May 14, 2027 |
| Prime | Department of Health and Human Services National Institutes of Health | PRECLINICAL MODELS OF INFECTIOUS DISEASES | HHSN272201700018IUSAspending | $781,872 | Dec 18, 2024 | Aug 3, 2022 – Aug 2, 2025 |
| Prime | Department of Defense Department of the Navy | PR # 82-1036-22 UNRAVELLING THE ROLE OF THE TRANSITION METALS, CARBON, AND NITROGEN IN THE DIFFUSION AND CREEP OF MIXED TRANSITION METAL CARBO-NITRIDES | — | $265,011 | Dec 13, 2024 | Apr 21, 2023 – Apr 23, 2025 |
| Prime | Department of Health and Human Services National Institutes of Health | TESTING OF DRUG COMBINATIONS FOR MYCOBACTERIUM TUBERCULOSIS (MTB) IN MICE | 75N93021D00014USAspending | $1,457,348 | Sep 10, 2024 | Sep 1, 2022 – Nov 30, 2025 |
| Prime | Department of Health and Human Services National Institutes of Health | PRE-CLINICAL MODELS OF INFECTIOUS DISEASES- DEVELOPMENT OF MOSQUITO CRYOPRESERVATION PROCESS FOR MOSQUITO VECTORS OF HUMAN PATHOGENS | HHSN272201700018IUSAspending | $544,180 | Jul 22, 2024 | Mar 23, 2020 – Dec 31, 2023 |
| Prime | Department of Health and Human Services National Institutes of Health | TO ISSUE TASK A28 BASE TASK ORDER FOR ADVANCED SMALL ANIMAL MODELS FOR THE TESTING OF CANDIDATE PREVENTIVE INTERVENTION AGAINST MYCOBACTERIUM TUBERCULOSIS | HHSN272201700018IUSAspending | $1,744,209 | Jul 22, 2024 | Jul 23, 2019 – Apr 30, 2022 |
| Prime | Department of Health and Human Services Centers for Disease Control and Prevention | IGF::OT::IGF FOR CRITICAL FUNCTIONS | — | $405,656 | Jun 21, 2024 | Jun 5, 2017 – Jul 4, 2022 |
| Prime | Department of Health and Human Services Centers for Disease Control and Prevention | IGF::OT::IGF ANIMAL CARE AND ASSOCIATED GLASWARE SERVICES | — | $1,802,488 | Jan 31, 2024 | Jun 16, 2014 – Sep 27, 2019 |
| Prime | Department of the Interior Bureau of Land Management | CNHP MLENTICETHODS AND PROTOCAL REFINEMENT TRAINING | — | $495,000 | Jan 8, 2024 | Sep 21, 2019 – Dec 31, 2021 |
| Prime | Department of Health and Human Services Centers for Disease Control and Prevention | YELLOW FEVER KITS | — | $637,404 | Nov 29, 2023 | Sep 10, 2018 – Jul 31, 2021 |
| Prime | Department of the Interior Departmental Offices | IGF::OT::IGF DHS R&D NEW AWARD | — | $3,123,728 | Aug 14, 2023 | Aug 3, 2015 – Mar 15, 2022 |
| Prime | Department of the Interior Departmental Offices | IGF::OT::IGF THIS EFFORT IS TO DEVELOP INNOVATIVE PLANNING TOOLS, SONATA AND SYMPHONY, THAT WILL ALLOW ASSESSING THE EPIDEMIOLOGICAL IMPACT AND ECONOMIC COSTS OF LIVESTOCK DISEASE OUTBREAKS AT THE NATIONAL SCALE WHILE RECONCILING THE HETEROGENEITY OF THE U.S. MAINLAND. | — | $2,027,931 | Aug 14, 2023 | Sep 25, 2015 – Sep 30, 2019 |
| Prime | Department of Defense Department of the Army | RC19-1119 | — | $1,801,343 | Jul 12, 2023 | Sep 26, 2019 – Sep 26, 2024 |
| Prime | Department of Health and Human Services National Institutes of Health | COVID19 - CSU/BIOMARC HUMAN CHALLENGE MATERIAL DEVELOPMENT | — | $2,956,550 | Mar 24, 2023 | Aug 17, 2020 – Aug 16, 2021 |
| Prime | Department of the Interior Departmental Offices | IGF::OT::IGF THIS EFFORT IS TO DEVELOP EXTENSIONS TO US ANIMAL MOVEMENT MODEL (USAMM) AND THE US DISEASE OUTBREAK SIMULATIION (USDOS)IN ORDER TO APPLY USAMM AND USDOS TO NEXT-GENERATION SURVEILLANCE, DIAGNOSTSIC AND COUNTER-MEASURES. | — | $1,434,310 | Sep 14, 2022 | Sep 25, 2015 – Sep 30, 2019 |
| Prime | Department of Transportation Maritime Administration | USMMA NHPA CULTURAL RESOURCES PROFESSIONAL | — | $409,142 | Apr 28, 2022 | Jul 16, 2019 – Apr 29, 2022 |
Contract vehicles are shown only when present in the source record. Linked award numbers and vehicles open the authoritative record on USAspending.gov.
Subcontracting experience
45 records from government sources. Past participation is not evidence of current teaming interest.
| Role | Agency | Description | Vehicle | Obligated | Action date | Period |
|---|---|---|---|---|---|---|
| Subcontractor | Department of Health and Human Services | THROUGH THE EXECUTION OF THIS CONTRACT, WE WILL EXAMINE BASIC INDUCTION OF INNATE AND ADAPTIVE IMMUNITY FROM VACCINATION, INCLUDING STUDIES THAT ADDRESS NONTUBERCULOUS MYCOBACTERIA (NTM) INTERFERENCE, RNA VACCINE DELIVERY, PRIME-BOOST REGIMENS (INCLUDING BCG PRE-EXPOSURE), TRANSCRIPTOMIC HOST SIGNATURES, SYSTEMS BIOLOGY AND DURABLE IMMUNE MEMORY FOR THE FURTHER ADVANCEMENT OF THE EFFORT TO DESIGN AND EVALUATE AN EFFICACIOUS VACCINE AGAINST MYCOBACTERIUM TUBERCULOSIS (M.TB).
THE WORK UNDER THIS CONTRACT MAY INCLUDE THE POSSIBLE DISTRIBUTION OF DE-IDENTIFIED HUMAN SUBJECT PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC), SERUM, AND OTHER CLINICAL SAMPLES TO SCRI AND THE PHOENIX PARTNERS. NHP-DERIVED SAMPLES AND/OR DOWNSTREAM DATA MAY BE SHARED WITH THE PARTNERS ON THIS CONTRACT.
OPTION 1 ACTIVITIES: EVALUATE OPTIMIZED M.TB VACCINE CANDIDATES FOR SAFETY, IMMUNOGENICITY, AND EFFICACY IN MOUSE TB MODELS
SIX-WEEK OLD MALE AND FEMALE C57BL/6 AND CBA (CBA EXCLUSIVELY USED IN TASK 1.4 & 1.5) MICE WILL BE MAINTAINED IN THE BIOSAFETY LEVEL-III BIOENVIRONMENTAL HAZARDS BUILDING AT COLORADO STATE UNIVERSITY, AND WILL BE GIVEN STERILE WATER, MOUSE CHOW, BEDDING, AND ENRICHMENT FOR THE DURATION OF THE EXPERIMENTS. ALL EXPERIMENTAL PROTOCOLS WILL BE APPROVED BY THE ANIMAL CARE AND USAGE COMMITTEE OF COLORADO STATE UNIVERSITY AS PER THE DEFINED DELIVERABLE IN THE BASE PERIOD.
SOME OF THE HARVESTED SAMPLES IN OPTION 1 TASKS OUTLINED BELOW WILL BE DISTRIBUTED TO COLLABORATOR SITES. CSU WILL PROVIDE THESE SAMPLES TO COLLABORATORS AS NEEDED AND PREDETERMINED BY THE NEEDS OF SOPS. THIS WILL INCLUDE BUT NOT BE LIMITED TO: SERUM OR BLOOD FOR ENDPOINT ANTIBODY ELISAS (SCRI), SYSTEMS SEROLOGY (HARVARD UNIVERSITY) AND TRANSCRIPTOMIC (FHCC) ASSAYS ACROSS SPECIES. FURTHERMORE, DATA GENERATED IN THIS OPTION WILL BE TRANSFERRED TO CSU AND FHCC SYSTEMS BIOLOGISTS IN THE CORRECT FORMAT, AS DEFINED IN THE BASE PERIOD, FOR INTEGRATED ANALYSIS. ITERATIVE ANALYSIS WILL INVOLVE PRECLINICAL BIOLOGISTS AND SYSTEMS BIOLOGISTS FOR OPTIMAL DATA INTEGRITY AND IMPACT.
MICE WILL BE PROPHYLACTICALLY VACCINATED ONCE WITH BCG [SUBCUTANEOUS OR INTRADERMAL] OR TWICE WITH ID93+GLA-SE [0.5 ΜG FUSION PROTEIN DELIVERED IN 5ΜG GLA STABLE EMULSION ADJUVANT INTRAMUSCULARLY]. CONTROL MICE WILL BE INJECTED WITH SALINE OR GLA-SE ALONE ON THE SAME REGIMEN AS ID93+GLA-SE. IN CHALLENGE STUDIES WE WILL INFECT GROUPS OF MICE (4 MALE AND 4 FEMALE, 8 TOTAL PER GROUP) BY LOW-DOSE AEROSOL (LDA, 50-100 BACTERIA INTO THE LUNGS) WITH ONE EXPERIMENT SUITE RECEIVING LABORATORY ISOLATE M.TB ERDMAN AND A SEPARATE SUITE RECEIVING CLINICAL ISOLATE M.TB HN878. FOR AEROSOL CHALLENGE, MICE ARE PLACED IN A GLAS-COL CIRCULAR [5-CHAMBER] STAINLESS STEEL CAGING SYSTEM WHICH IS THEN PLACED IN A CENTRAL CHAMBER AND SEALED BY A GASKET. AEROSOLIZED BACTERIA ARE GENERATED IN A NEBULIZER AND BLOWN THROUGH THE CENTRAL CHAMBER FOR 30-MINUTES, FOLLOWED BY CLEAN AIR AND BRIEF EXPOSURE TO ULTRA-VIOLET LIGHT.
TABLE 1: PRECLINICAL DESIGN FOR TASK 1.2 AND TASK 1.3
GROUP PRIME1 FIRST BOOST2 SECOND BOOST3 CHALLENGE4
1 BCG SALINE SALINE LDA M.TB ERDMAN OR HN878
2 BCG ID93+GLA-SE ID93+GLA-SE
3 SALINE SALINE SALINE
4 SALINE ID93+GLA-SE ID93+GLA-SE
5 SALINE SALINE SALINE NO CHALLENGE
1 BCG DELIVERED I.D./S.C. AT THE BASE OF THE TAIL. 2 FIRST BOOST DELIVERED I.M. 120 DAYS POST PRIME IMMUNIZATION. 3 SECOND BOOST DELIVERED I.M. 56 DAYS POST FIRST BOOST. 4 CHALLENGE WITH A LDA M.TB ERDMAN OR M.TB HN878 56 DAYS POST SECOND BOOST.
TASK 1.2. EVALUATE IMMUNOGENICITY OF ID93+GLA-SE TB CANDIDATE VACCINE IN C57BL/6 MICE.
PRE-CHALLENGE IMMUNE PROFILE OF ID93+GLA-SE. PRE-CHALLENGE IMMUNOGENICITY ASSAYS OF C57BL/6 MICE (4 MALE AND 4 FEMALE, 8 TOTAL PER GROUP) IMMUNIZED WITH BCG, ID93+GLA-SE OR A COMBINATION WILL INCLUDE ADAPTIVE T CELL IMMUNITY USING WHOLE BLOOD OR PBMC (AS DETERMINED IN THE BASE PERIOD) WITH AT LEAST AN 18 COLOR ICS AND ICS FROM THE SPLEEN, AND HUMORAL RESPONSES USING A SURROGATE B CELL ASSAY (BONE-MARROW PLASMA CELL AS SUB00002560 Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: WA Parent award description: IMMUNE MECHANISMS OF PROTECTION AGAINST MYCOBACTERIUM TUBERCULOSIS CENTER (IMPAC-TB) View parent award on USAspending | — | $1,125,492 | Jan 12, 2026 | — – — |
| Subcontractor | Department of Defense | ASSISTING WITH RESEARCH TO DEVELOP HIGH-THROUGHPUT PATHOGEN INACTIVATION
DEVICE GS.10000739.BIOMARC Parent award context Parent award agency: Department of Defense · Defense Health Agency Parent award NAICS: 541715 Parent award performance state: CO Parent award description: DHA PHASE II SBIR CONTRACT FOR PSORALEN-UV-A INACTIVATION BASED HIGH-THROUGHPUT PATHOGEN INACTIVATION DEVICE View parent award on USAspending | — | $372,003 | Dec 8, 2025 | — – — |
| Subcontractor | Department of the Interior | PROVIDE ENGINEERING SERVICES IN SUPPORT OF THE BYTE RI SEQUENTIAL PHASE II PROGRAM. 1194-SB Parent award context Parent award agency: Department of the Interior · Departmental Offices Parent award NAICS: 541715 Parent award performance state: NY Parent award description: STTR PHASE II CONTRACT WITH ASSURED INFORMATION SECURITY, INC. View parent award on USAspending | — | $49,502 | Sep 25, 2025 | — – — |
| Subcontractor | Department of Transportation | PHASE I STATE OF PRACTICE AND DRAFT FRAMEWORK
TASK 1. CONDUCT LITERATURE REVIEW
• DR. HARPER AND HIS RESEARCH ASSISTANT WILL ASSIST THE TEAM WITH COLLECTING RELEVANT LITERATURE AND REVIEWING IT FOR CONTENT FOR THIS STUDY. DR. HARPER WILL ALSO HELP IN REVIEWING THE INFORMATION GLEANED FROM THE LITERATURE REVIEW, INCLUDING IDENTIFYING GAPS IN EXISTING RESEARCH.
TASK 2. CONDUCT DESK SCAN AND DATA SYNTHESIS
• DR. HARPER AND HIS RESEARCH ASSISTANT WILL ASSIST THE TEAM IN RESEARCHING THE CURRENT STATE OF PRACTICE IN CONSTRUCTION INSPECTOR TRAINING AND CERTIFICATION FOR BRIDGE CONSTRUCTION AT AGENCIES. DR. HARPER AND HIS RESEARCH ASSISTANT WILL REVIEW DATA SETS FROM PREVIOUS RESEARCH PROJECTS RELATED TO THIS STUDY AND WILL REVIEW THE ANALYSIS OF THE DATA AND ANY FINDINGS.
TASK 3. IDENTIFY GAPS IN BRIDGE CONSTRUCTION INSPECTION CERTIFICATION
• DR. HARPER WILL ASSIST THE TEAM WITH DETERMINING GAPS IN EXISTING TRAINING AND CERTIFICATION PROGRAMS FOR BRIDGE AND TUNNEL CONSTRUCTION INSPECTORS BASED ON INFORMATION COLLECTED IN TASK 2.
TASK 4. CONDUCT WEBINARS WITH AASHTO REGIONS
• DR. HARPER WILL CO-LEAD THIS TASK WITH HELP FROM HIS RESEARCH ASSISTANT THE REST OF THE PROJECT TEAM TO DEVELOP, CONDUCT, AND FACILITATE THE WEBINARS WITH CONSTRUCTION INDUSTRY PROFESSIONALS WITH EXPERTISE IN INSPECTION TRAINING AND CERTIFICATION FOR BRIDGE AND TUNNEL CONSTRUCTION.
TASK 5. DEVELOP DRAFT BRIDGE CONSTRUCTION INSPECTION CERTIFICATION FRAMEWORK
• DR. HARPER WILL HELP DEVELOP AND REVIEW THE DRAFT CONSTRUCTION INSPECTION CERTIFICATION FRAMEWORK FOR BRIDGE AND TUNNEL INSPECTORS.
PHASE II VETTING AND FINALIZING FRAMEWORK
TASK 6. REVIEW FRAMEWORK WITH SUBJECT MATTER EXPERTS
• DR. HARPER WILL HELP PREPARE FOR AND CONDUCT MEETINGS WITH TUNNEL AND BRIDGE CONSTRUCTION INSPECTION EXPERTS TO TEST THE COMPLETENESS AND APPROPRIATENESS OF THE DRAFT FRAMEWORK. THE RESEARCH ASSISTANT WILL HELP WITH SETTING UP THE MEETINGS.
TASK 7. CONDUCT VETTING WORKSHOPS WITH SELECT STATE DOTS
• DR. HARPER AND HIS RESEARCH ASSISTANT WILL HELP LEAD THE EFFORTS TO DEVELOP THE WORKSHOPS, CONTACT POTENTIAL PARTICIPANTS, SET UP THE TIME AND PLACE, AND FACILITATE THE WORKSHOPS ONCE WE ARE READY TO CONDUCT THEM. DR. HARPER’S RESEARCH ASSISTANT WILL HELP DURING THE WORKSHOPS BY COLLECTING INFORMATION AND TAKING NOTES.
TASK 8. DEVELOP FINAL DRAFT BRIDGE AND TUNNEL CONSTRUCTION INSPECTION FRAMEWORK
• BASED ON THE FEEDBACK FROM TASK 7, DR. HARPER AND HIS RESEARCH ASSISTANT WILL HELP THE TEAM TO REVISE THE DRAFT FRAMEWORK INTO ITS FINAL VERSION AS THE PRIMARY DELIVERABLE FOR THIS PROJECT.
TASK 9. DEVELOP FINAL DELIVERABLES AND DISSEMINATE RESULTS
• DR. HARPER WILL ASSIST THE TEAM IN REFINING AND COMPLETING ALL FINAL DELIVERABLES AND WILL PARTICIPATE IN MEETINGS, WEBINARS, AND PRESENTATIONS TO DISSEMINATE THE RESULTS. 3200006873-25-245 Parent award context Parent award agency: Department of Transportation · Federal Highway Administration Parent award NAICS: 541330 Parent award performance state: KY Parent award description: PRACTICAL FRAMEWORK FOR A BRIDGE AND TUNNEL CONSTRUCTION INSPECTION CERTIFICATION PROGRAM View parent award on USAspending | — | $73,828 | May 8, 2025 | — – — |
| Subcontractor | Department of Transportation | ELD CERTIFICATION STUDY 451940-19019 Parent award context Parent award agency: Department of Transportation · Federal Motor Carrier Safety Administration Parent award NAICS: 541715 Parent award performance state: VA Parent award description: ELECTRONIC LOGGIN DEVICE (ELD) CERTIFICATION STUDY View parent award on USAspending | 693JJ420D000005USAspending | $288,000 | Jan 21, 2025 | — – — |
| Subcontractor | Department of Health and Human Services | THIS STATEMENT OF WORK (SOW) OUTLINES THE ACTIVITIES THAT COLORADO STATE UNIVERSITY (CSU) WILL BE PERFORMING THROUGHOUT THE PROPOSED WORK PERIOD. THE TASK NUMBERS BELOW REFLECT THE NUMBERING OF ACTIVITIES IN THE M72-SPECIFIC PACKAGE OF THE PRIME CONTRACT.
THROUGH THE EXECUTION OF THIS CONTRACT, WE WILL EXAMINE PREVENTION OF DISEASE OUTCOMES AND ARCHIVE SAMPLES FOR ANALYZING BASIC INDUCTION OF INNATE AND ADAPTIVE IMMUNITY FROM VACCINATION, TO BE COMPLETED IF FUNDS ARE AVAILABLE. THIS WORK WILL INCLUDE STUDIES THAT ADDRESS BCG PRIME AND BOOSTS WITH M72 COMBINED WITH 3 DIFFERENT ADJUVANT SYSTEMS IN THE GUINEA PIG MODEL. PBMC WILL BE COLLECTED AND ARCHIVED FOR IMMUNOGENICITY AND POST-INFECTION ANALYSIS WITH MYCOBACTERIUM TUBERCULOSIS (M.TB) ERDMAN, IF FUNDS ARE AVAILABLE, IN AN EFFORT TO DESIGN AND EVALUATE AN EFFICACIOUS VACCINE AGAINST MYCOBACTERIUM TUBERCULOSIS (M.TB).
THE WORK UNDER THIS CONTRACT MAY INCLUDE THE POSSIBLE DISTRIBUTION OF DE-IDENTIFIED HUMAN SUBJECT PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC) AND OTHER CLINICAL SAMPLES TO SCRI AND THE PHOENIX PARTNERS.
OPTION 2.M72 ACTIVITIES
TASK 2.M72. EVALUATE IMMUNOGENICITY AND POD EFFICACY OF M72 COMBINED WITH DIFFERENT ADJUVANT FORMULATIONS AGAINST M.TB IN GUINEA PIGS
SOME OF THE HARVESTED SAMPLES IN THIS M72 TASK OUTLINED BELOW WILL BE DISTRIBUTED TO COLLABORATOR SITES. CSU WILL PROVIDE THESE SAMPLES TO COLLABORATORS AS NEEDED AND PREDETERMINED BY THE NEEDS OF SOPS. THIS WILL INCLUDE BUT NOT BE LIMITED TO: SERUM OR BLOOD FOR ENDPOINT ANTIBODY ELISAS (SCRI), SYSTEMS SEROLOGY (HSPH) AND TRANSCRIPTOMIC (FHCC) ASSAYS ACROSS SPECIES. FURTHERMORE, DATA GENERATED IN THIS OPTION WILL BE TRANSFERRED TO CSU AND FHCC SYSTEMS BIOLOGISTS IN THE CORRECT FORMAT, AS DEFINED IN THE BASE PERIOD, FOR INTEGRATED ANALYSIS. ITERATIVE ANALYSIS WILL INVOLVE PRECLINICAL BIOLOGISTS AND SYSTEMS BIOLOGISTS FOR OPTIMAL DATA INTEGRITY AND IMPACT.
GUINEA PIG STUDIES WILL BE PERFORMED IN PARALLEL IMMUNOPATHOLOGIC STUDIES, USING THE LABORATORY ISOLATE, M.TB ERDMAN. GUINEA PIGS WILL BE BCG OR MOCK VACCINATED AND AFTER 120 DAYS, GUINEA PIGS WILL BE MOCK BOOSTED, OR BOOSTED WITH TWO INTERVALS OF THE M72 CANDIDATE VACCINE + 3 CANDIDATE ADJUVANTS, INCLUDING GLA-SE, GLA-LSQ, OR UM-1098. GUINEA PIGS WILL BE INFECTED WITH 20-50 BACILLI OF M.TB ERDMAN AND SAMPLES WILL BE HARVESTED AT VARIOUS INTERVALS. WE WILL DETERMINE THE COURSE OF THE INFECTIONS BY MEASURING CFU LEVELS IN THE LUNGS AND BRONCHOALVEOLAR LAVAGE CELLS, AND DETERMINE PROTECTIVE EFFICACY OF VACCINE STRATEGIES USING QUANTITATIVE HISTOPATHOLOGY. SAMPLES WILL BE COLLECTED AND ARCHIVED FOR DOWNSTREAM USE, BUT NOT FULLY ANALYZED, INCLUDING: PBMC TO MEASURE VACCINE IMMUNOGENICITY STUDIES PRE-INFECTION AND PERIPHERAL RESPONSE POST-INFECTION, SERUM FOR SYSTEMS SEROLOGY AND CYTOKINE ELISA, LUNG AND SPLEEN CELL SUSPENSIONS FOR ANTIGEN STIMULATION AND CYTOKINE ANALYSIS, LUNG TISSUE FOR CYTOKINE ELISA, AND BAL FLUID FOR CYTOKINE ELISA. PARAFORMALDEHYDE-FIXED LUNG TISSUE WILL BE ARCHIVED IN PARAFFIN BLOCKS. IN SITU ANALYSIS OF BACTERIAL RESPONSE WILL BE ANALYZED BY RNASCOPE ISH ON FORMALIN-FIXED PARAFFIN-EMBEDDED LUNG TISSUE AND ON CELLS ISOLATED BY BRONCHOALVEOLAR LAVAGE TO DETECT BACTERIA-SPECIFIC TRANSCRIPTS, WHICH HAS THE POTENTIAL TO REVEAL THEIR PRECISE LOCATION AND REPLICATIVE STATE IN LESIONS.
LUNG AND SPLEEN TISSUE WILL BE COLLECTED FOR HISTOPATHOLOGICAL EXAMINATION AT POST-MORTEM. THE SAMPLES FOR HISTOLOGY WILL BE COLLECTED INTO 4% PARAFORMALDEHYDE IN LABELLED POTS PROVIDED BY THE STUDY DIRECTOR FROM THE HISTOLOGY DEPARTMENT. THE TISSUES COLLECTED AT NECROPSY WILL BE TRANSFERRED TO THE HISTOLOGY DEPARTMENT WHERE THEY WILL BE PROCESSED TO PARAFFIN FOR ROUTINE SECTIONING AND THEN HEMATOXYLIN AND EOSIN (H&E) STAINING WILL BE PERFORMED. SLIDES WILL BE EXAMINED MICROSCOPICALLY BY IN-HOUSE VETERINARY PATHOLOGISTS AND A DESCRIPTIVE REPORT OF THE NATURE OF THE DISEASE IN THE TARGET ORGANS IN EACH GROUP, TOGETHER WITH RELEVANT DATA TABLES, WILL BE PROVIDED F 13475SUB Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: WA Parent award description: IMMUNE MECHANISMS OF PROTECTION AGAINST MYCOBACTERIUM TUBERCULOSIS CENTER (IMPAC-TB) View parent award on USAspending | — | $424,038 | Nov 30, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | THIS STATEMENT OF WORK (SOW) OUTLINES THE ACTIVITIES THAT COLORADO STATE UNIVERSITY (CSU) WILL BE PERFORMING THROUGHOUT THE PROPOSED WORK PERIOD. NOTE THAT THE TASK NUMBERS BELOW REFLECT THE NUMBERING OF THE OVERALL ACTIVITIES IN THE PRIME CONTRACT.
THROUGH THE EXECUTION OF THIS CONTRACT, WE WILL EXAMINE BASIC INDUCTION OF INNATE AND ADAPTIVE IMMUNITY FROM VACCINATION, INCLUDING STUDIES THAT ADDRESS NONTUBERCULOUS MYCOBACTERIA (NTM) INTERFERENCE, RNA VACCINE DELIVERY, PRIME-BOOST REGIMENS (INCLUDING BCG PRE-EXPOSURE), TRANSCRIPTOMIC HOST SIGNATURES, SYSTEMS BIOLOGY AND DURABLE IMMUNE MEMORY FOR THE FURTHER ADVANCEMENT OF THE EFFORT TO DESIGN AND EVALUATE AN EFFICACIOUS VACCINE AGAINST MYCOBACTERIUM TUBERCULOSIS (M.TB).
THE WORK UNDER THIS CONTRACT MAY INCLUDE THE POSSIBLE DISTRIBUTION OF DE-IDENTIFIED HUMAN SUBJECT PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC), SERUM, AND OTHER CLINICAL SAMPLES TO SCRI AND THE PHOENIX PARTNERS. NHP-DERIVED SAMPLES AND/OR DOWNSTREAM DATA MAY BE SHARED WITH THE PARTNERS ON THIS 13474SUB Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: WA Parent award description: IMMUNE MECHANISMS OF PROTECTION AGAINST MYCOBACTERIUM TUBERCULOSIS CENTER (IMPAC-TB) View parent award on USAspending | — | $1,412,285 | Nov 30, 2024 | — – — |
| Subcontractor | Department of Defense | DEFENSE AGAINST BURKHOLDERIA PSEUDOMALLEI INFECTION: SUBUNIT VACCINE AND MONOCLONAL ANTIBODY/NANOBODY TECHNOLOGIES MA1638 Parent award context Parent award agency: Department of Defense · Defense Threat Reduction Agency Parent award NAICS: 541715 Parent award performance state: HI Parent award description: DEFENSE AGAINST BURKHOLDERIA PSEUDOMALLEI INFECTION: SUBUNIT VACCINE AND MONOCLONAL ANTIBODY/NANOBODY TECHNOLOGIES View parent award on USAspending | — | -$70,214 | Nov 20, 2024 | — – — |
| Subcontractor | Department of Defense | WILL SCALE THE DOD€„¢S PSORALEN-UV-A IRRADIATION PROCESS TO DEVELOP A DEVICE TO INACTIVATE PATHOGENS IN A CONTINUOUS-FLOW DEVICE CAPABLE OF PRODUCING 0.010 TO 50 L OF VACCINE, AS REQUESTED BY THE DHA. GS.10000692.CSU · Prime awardUSAspending | — | $43,121 | Nov 12, 2024 | — – — |
| Subcontractor | Department of the Interior | PROVIDE ENGINEERING SERVICES IN SUPPORT OF THE BYTE RI SEQUENTIAL PHASE II PROGRAM. 1194-SB Parent award context Parent award agency: Department of the Interior · Departmental Offices Parent award NAICS: 541715 Parent award performance state: NY Parent award description: STTR PHASE II CONTRACT WITH ASSURED INFORMATION SECURITY, INC. View parent award on USAspending | — | $42,524 | Sep 24, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | TECHNICAL SERVICES 4500103599 Parent award context Parent award agency: Department of Health and Human Services · Office of Assistant Secretary for Preparedness and Response Parent award NAICS: 541714 Parent award performance state: CA Parent award description: DIAZYME: FINALIZE DESIGN VERIFICATION, OBTAIN REGULATORY APPROVAL (EUA AND 510K), SCALE UP PRODUCTION AND DEPLOY THE DIAZYME SARS-COV-2 NEUTRALIZING ANTIBODY CLIA KIT. View parent award on USAspending | — | $82,000 | Sep 16, 2024 | — – — |
| Subcontractor | Department of Defense | OBJECTIVES: THE ULTIMATE OBJECTIVE OF THE PROPOSED PROJECT IS TO DEVELOP AN IMPROVED PHYSICS€Ͽ½BASED COMPUTATIONAL CAPABILITY FOR RELIABLY PREDICTING FINE€Ͽ½ TO LANDSCAPE€Ͽ½SCALE WILDLAND FIRE BEHAVIOR, INCLUDING REALISTIC ESTIMATES OF PARTICULATE MATTER (PM) EMISSIONS AND EMBER PRODUCTION, FOR DIFFERENT FUEL AND ENVIRONMENTAL CONDITIONS. THIS EFFORT IS AN EXTENSION OF A PREVIOUS SERDP PROJECT (RC€Ͽ½ 2642) THAT INVOLVED HOFFMAN THAT WAS FOCUSED ON FUEL PYROLYSIS, IGNITION, AND COMBUSTION AT SUB€Ͽ½METER SCALES. HERE WE WILL USE PARTICLE IMAGE VELOCIMETRY, GAS CHROMATOGRAPHY, MASS SPECTROMETRY, AND NOVEL MID€Ͽ½INFRARED FREQUENCY COMB LASER DIAGNOSTICS TO STUDY FLAME SPREAD, EMISSIONS, AND EMBER PRODUCTION IN A ONE€Ͽ½OF€Ͽ½A€Ͽ½ KIND VARIABLE SLOPE WIND TUNNEL, DEVELOP NEW SUB GRID SCALE MODELS FOR LANDSCAPE SCALE LES FIRE SIMULATIONS AND PERFORM FIELD INVESTIGATIONS OF WILDLAND FIRE.
CSU SCOPE OF WORK:
A) CSU WILL AID IN THE DEVELOPMENT OF WINDCLINE EXPERIMENTS TO INVESTIGATE THE ROLE OF FUEL MOISTURE CONTENT, TYPE, AND HETEROGENEITY, WIND SPEED, AND SLOPE AFFECT FLAME SPREAD, EMBER PRODUCTION, AND EMISSIONS.
B) CSU WILL ASSIST IN THE DEVELOPMENT AND TESTING OF NEW SGS MODELS IN FIRETEC
C) CSU COORDINATE DATA COLLECTION ON SEVERAL EXPERIMENTAL PRESCRIBED FIRES ASSOCIATED WITH SERDP PROJECT RC19€Ͽ½C1€Ͽ½119 (HOFFMAN PI). FOR EACH EXPERIMENTAL RX FIRE CSU WILL COLLECT 3D FUELS FOR THE OVERSTORY, MIDSTORY AND UNDERSTORY USING COMBINATION OF DESTRUCTIVE AND NON€Ͽ½DESTRUCTIVE TECHNIQUES. COLLECT PRE€Ͽ½FIRE FUEL MOISTURE DATA USING A COMBINATION OF IR PHOTOGRAPHY AND TRADITIONAL FIELD SAMPLING APPROACHES. CHARACTERIZE FIRE INDUCED AND AMBIENT WIND FLOW USING SEVERAL 10 M TOWERS INSTRUMENTED WITH SONIC ANEMOMETERS. USE THERMOGRAPHY TO ASSESS HEAT RELEASE RATES AND CAPTURE FIRE SPREAD AND CONSUMPTION WITHIN THE BURN AREAS. ALL FIELD€Ͽ½SCALE MEASUREMENTS WILL BUILD UPON THE INITIAL RESULTS AND FINDINGS FROM SERDP RC19€Ͽ½C1€Ͽ½119 1560095 Parent award context Parent award agency: Department of Defense · Department of the Army Parent award NAICS: 541715 Parent award performance state: VA Parent award description: SERDP RC20-1382 View parent award on USAspending | — | $192,227 | Aug 23, 2024 | — – — |
| Subcontractor | Department of Defense | 3D MODELING OF GARRISON DAM 24S31392LB10 Parent award context Parent award agency: Department of Defense · Department of the Army Parent award NAICS: 541330 Parent award performance state: CO Parent award description: GARRISON SPILLWAY MODELING View parent award on USAspending | W9128F19D0009USAspending | $701,703 | Aug 20, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | THROUGH THE EXECUTION OF THIS CONTRACT, WE WILL EXAMINE BASIC INDUCTION OF INNATE AND ADAPTIVE IMMUNITY FROM VACCINATION, INCLUDING STUDIES THAT ADDRESS NTM INTERFERENCE, RNA DELIVERY, PRIME-BOOST REGIMENS (INCLUDING BCG PRE-EXPOSURE), TRANSCRIPTOMIC HOST SIGNATURES, SYSTEMS BIOLOGY AND DURABLE IMMUNE MEMORY FOR THE FURTHER ADVANCEMENT OF THE EFFORT TO DESIGN AND EVALUATE AN EFFICACIOUS VACCINE AGAINST MYCOBACTERIUM TUBERCULOSIS (M.TB).
OPTION 1 ACTIVITIES: EVALUATE OPTIMIZED M.TB VACCINE CANDIDATES FOR SAFETY, IMMUNOGENICITY AND EFFICACY IN MOUSE TB MODELS
SIX-WEEK OLD MALE AND FEMALE C57BL/6 AND CBA (CBA EXCLUSIVELY USED IN TASK 1.4 & 1.5) MICE WILL BE MAINTAINED IN THE BIOSAFETY LEVEL-III BIOENVIRONMENTAL HAZARDS BUILDING AT COLORADO STATE UNIVERSITY, AND WILL BE GIVEN STERILE WATER, MOUSE CHOW, BEDDING, AND ENRICHMENT FOR THE DURATION OF THE EXPERIMENTS. ALL EXPERIMENTAL PROTOCOLS WILL BE APPROVED BY THE ANIMAL CARE AND USAGE COMMITTEE OF COLORADO STATE UNIVERSITY AS PER THE DEFINED DELIVERABLE IN THE BASE PERIOD.
SOME OF THE HARVESTED SAMPLES IN OPTION 1 TASKS OUTLINED BELOW WILL BE DISTRIBUTED TO COLLABORATOR SITES. CSU WILL PROVIDE THESE SAMPLES TO COLLABORATORS AS NEEDED AND PREDETERMINED BY THE NEEDS OF SOPS. THIS WILL INCLUDE BUT NOT BE LIMITED TO: SERUM OR BLOOD FOR ENDPOINT ANTIBODY ELISAS (SCRI), SYSTEMS SEROLOGY (RAGON) AND TRANSCRIPTOMIC (FHCC) ASSAYS ACROSS SPECIES. FURTHERMORE, DATA GENERATED IN THIS OPTION WILL BE TRANSFERRED TO CSU AND FHCC SYSTEMS BIOLOGISTS IN THE CORRECT FORMAT, AS DEFINED IN THE BASE PERIOD, FOR INTEGRATED ANALYSIS. ITERATIVE ANALYSIS WILL INVOLVE PRECLINICAL BIOLOGISTS AND SYSTEMS BIOLOGISTS FOR OPTIMAL DATA INTEGRITY AND IMPACT.
MICE WILL BE PROPHYLACTICALLY VACCINATED ONCE WITH BCG [SUBCUTANEOUS OR INTRADERMAL] OR TWICE WITH ID93+GLA-SE [0.5 ÂÂΜG FUSION PROTEIN DELIVERED IN 5ÂÂΜG GLA STABLE EMULSION ADJUVANT INTRAMUSCULARLY]. CONTROL MICE WILL INJECTED WITH SALINE OR GLA-SE ALONE ON THE SAME REGIMEN AS ID93+GLA-SE. IN CHALLENGE STUDIES WE WILL INFECT GROUPS OF MICE (4 MALE AND 4 FEMALE, 8 TOTAL PER GROUP) BY LOW-DOSE AEROSOL (LDA, 50-100 BACTERIA INTO THE LUNGS) WITH ONE EXPERIMENT SUITE RECEIVING LABORATORY ISOLATE M.TB ERDMAN AND A SEPARATE SUITE RECEIVING CLINICAL ISOLATE M.TB HN878. FOR AEROSOL CHALLENGE, MICE ARE PLACED IN A GLAS-COL CIRCULAR [5-CHAMBER] STAINLESS STEEL CAGING SYSTEM WHICH IS THEN PLACED IN A CENTRAL CHAMBER AND SEALED BY A GASKET. AEROSOLIZED BACTERIA ARE GENERATED IN A NEBULIZER AND BLOWN THROUGH THE CENTRAL CHAMBER FOR 30-MINUTES, FOLLOWED BY CLEAN AIR AND BRIEF EXPOSURE TO ULTRA-VIOLET LIGHT.
TABLE 3: PRECLINICAL DESIGN FOR TASK 1.2 AND TASK 1.3
GROUP PRIME1 FIRST BOOST2 SECOND BOOST3 CHALLENGE4
1 BCG SALINE SALINE LDA M.TB ERDMAN
2 BCG ID93+GLA-SE ID93+GLA-SE
3 SALINE SALINE SALINE
4 SALINE ID93+GLA-SE ID93+GLA-SE
5 SALINE SALINE SALINE NO CHALLENGE
1 BCG DELIVERED I.D./S.C. AT THE BASE OF THE TAIL. 2 FIRST BOOST DELIVERED I.M. 120 DAYS POST PRIME IMMUNIZATION. 3 SECOND BOOST DELIVERED I.M. 56 DAYS POST FIRST BOOST. 4 CHALLENGE WITH A LDA M.TB ERDMAN OR M.TB HN878 56 DAYS POST SECOND BOOST.
TASK 1.2. EVALUATE IMMUNOGENICITY OF ID93+GLA-SE TB CANDIDATE VACCINE IN C57BL/6 MICE.
PRE-CHALLENGE IMMUNE PROFILE OF ID93+GLA-SE. PRE-CHALLENGE IMMUNOGENICITY ASSAYS OF C57BL/6 MICE (4 MALE AND 4 FEMALE, 8 TOTAL PER GROUP) IMMUNIZED WITH BCG, ID93+GLA-SE OR A COMBINATION WILL INCLUDE ADAPTIVE T CELL IMMUNITY USING WHOLE BLOOD OR PBMC (AS DETERMINED IN THE BASE PERIOD) 19 COLOR ICS AND ICS FROM THE SPLEEN, AND HUMORAL RESPONSES USING A SURROGATE B CELL ASSAY (BONE-MARROW PLASMA CELL ASSAY), AND SEROLOGIC ANALYSIS (INCLUDING ANTIBODY END POINT ASSAYS FOR CHARACTERIZATION OF ANTIBODY SUBTYPES/ISOTYPES). IN ADDITION TO WEIGHING MICE BEFORE AND DAILY FOR 1-WEEK FOLLOWING EACH IMMUNIZATION, NON-TERMINAL BLOOD WILL BE COLLECTED POST IMMUNIZATION FOR SERUM TO BE STORED FOR FUTURE BIOMARKER ANALYSIS (EG. CRP) AS MEASURES OF PRECLINICAL SAFETY.
ICS FOR T CELL PHENOT 13293SUB Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: WA Parent award description: IMMUNE MECHANISMS OF PROTECTION AGAINST MYCOBACTERIUM TUBERCULOSIS CENTER (IMPAC-TB) View parent award on USAspending | — | $899,772 | May 31, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | THROUGH THE EXECUTION OF THIS CONTRACT, WE WILL EXAMINE BASIC INDUCTION OF INNATE AND ADAPTIVE IMMUNITY FROM VACCINATION, INCLUDING STUDIES THAT ADDRESS NONTUBERCULOUS MYCOBACTERIA (NTM) INTERFERENCE, RNA DELIVERY, PRIME-BOOST REGIMENS (INCLUDING BCG PRE-EXPOSURE), TRANSCRIPTOMIC HOST SIGNATURES, SYSTEMS BIOLOGY AND DURABLE IMMUNE MEMORY FOR THE FURTHER ADVANCEMENT OF THE EFFORT TO DESIGN AND EVALUATE AN EFFICACIOUS VACCINE AGAINST MYCOBACTERIUM TUBERCULOSIS (M.TB).
M72 OPTION 3A ACTIVITIES: EVALUATE IMMUNE RESPONSE, SAFETY AND EFFICACY OF M72 WITH THREE LEAD ADJUVANTS
THE SYSTEMS BIOLOGY WORK WILL ENCOMPASS CROSS-SPECIES CORRELATES OF IMMUNITY AND EFFICACY ITERATIVE SYSTEMS BIOLOGY WORKFLOWS RELATED TO M72-CONTAINING VACCINES (SYSTEMS BIOLOGY EFFORT, PROTOCOL DEVELOPMENT FOR UNIFORM COLLECTION AND STORAGE OF DATA ACROSS ALL DATA GENERATORS AND DATA ANALYSTS; DATA PROCESSING AND ANALYSIS PIPELINES WILL BE DEVELOPED TO ACCOMMODATE TRANSCRIPTOMIC PROFILING OF M72 NHP SAMPLES AND DATA).
CONTRACT OPTION-SPECIFIC TASK TABLE OF DELIVERABLES:
DELIVERABLE TASK DESCRIPTION PERIOD OF PERFORMANCE DUE DATE
M72 EVALUATE IMMUNE RESPONSE, SAFETY AND EFFICACY OF M72 WITH 3 LEAD ADJUVANTS 8/2023 €€Œ 7/2024 31 JULY 2024
REPORTING REQUIREMENTS:
ALL REPORTS MUST BE SUBMITTED TO THE PRIME CONTRACTOR€„¢S PRINCIPAL INVESTIGATOR IDENTIFIED IN ATTACHMENT 3A.
DESCRIPTION DELIVERY SCHEDULE
MONTHLY PROGRESS REPORTS 8TH OF THE MONTH FOLLOWING THE REPORTING PERIOD.
REPORTING TEMPLATE USED IS AT THE DISCRETION OF THE SUBCONTRACTOR AS LONG AS IT CONTAINS THE FOLLOWING INFORMATION WITH HEADERS: CURRENT TASK; PROGRESS TOWARDS OBJECTIVES; CHALLENGES; NEXT STEPS/RECOMMENDATIONS.
ANNUAL PROGRESS REPORT 8TH OF THE MONTH FOLLOWING EACH ANNIVERSARY DATE OF THE SUBCONTRACT. THE NEXT ANNUAL REPORT IS DUE ON AUGUST 8TH, 2024.
FINAL REPORT 15 DAYS AFTER THE LAST DAY OF THE PROJECT.
ANNUAL UTILIZATION REPORT ON OR BEFORE THE 15TH OF THE MONTH FOLLOWING EACH ANNIVERSARY DATE OF THE SUBCONTRACT.
FINAL INVENTION STATEMENT DUE ON THE COMPLETION OF THE CONTRACT END DATE. 13284SUB Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: WA Parent award description: IMMUNE MECHANISMS OF PROTECTION AGAINST MYCOBACTERIUM TUBERCULOSIS CENTER (IMPAC-TB) View parent award on USAspending | — | $29,849 | May 31, 2024 | — – — |
| Subcontractor | Department of Energy | REDESIGN TOMORROW'S CIRCULAR POLYMERS USING BIO-BASED OR WASTE-PLASTIC-DERIVED BUILDING BLOCKS UGA-0-41027-55 Parent award context Parent award agency: Department of Energy · Department of Energy Parent award NAICS: 541711 Parent award performance state: CO Parent award description: AWARD OF CONTRACT TO MANAGE AND OPERATE THE NATIONAL RENEWABLE ENERGY LABORATORY View parent award on USAspending | — | $3,000,000 | Apr 30, 2024 | — – — |
| Subcontractor | National Aeronautics and Space Administration | ALL OTHER PROFESSIONAL, SCIENTIFIC AND TECHNICAL SERVICES 5300094670 Parent award context Parent award agency: National Aeronautics and Space Administration · National Aeronautics and Space Administration Parent award NAICS: 541330 Parent award performance state: CA Parent award description: THE PURPOSE OF THIS CONTRACT IS A PHASE A DEFINITION STUDY FOR THE SOUNDER FOR MICROWAVE-BASED APPLICATIONS INSTRUMENTS, THE NEXT GENERATION LOW-EARTH ORBIT MICROWAVE SOUNDERS. View parent award on USAspending | — | -$88,091 | Apr 1, 2024 | — – — |
| Subcontractor | National Aeronautics and Space Administration | TECHNICAL SERVICES 5300094670 Parent award context Parent award agency: National Aeronautics and Space Administration · National Aeronautics and Space Administration Parent award NAICS: 541330 Parent award performance state: CA Parent award description: THE PURPOSE OF THIS CONTRACT IS A PHASE A DEFINITION STUDY FOR THE SOUNDER FOR MICROWAVE-BASED APPLICATIONS INSTRUMENTS, THE NEXT GENERATION LOW-EARTH ORBIT MICROWAVE SOUNDERS. View parent award on USAspending | — | $150,000 | Mar 28, 2024 | — – — |
| Subcontractor | Department of Defense | THIS PROJECT WILL PROVIDE SUPPORT AND OTHER SERVICES IN GUAM FOR ESTABLISHING A BASELINE INVENTORY OF ARTHROPODS USING METABARCODING AND NEW SOURCES OF EDNA. THE WORK WILL INVOLVE FIELD COLLECTIONS OF ARTHROPODS, INCLUDING COLLECTIONS ON MILITARY LANDS IN GUAM AND MILITARY LEASED AREAS IN THE COMMONWEALTH OF THE NORTHERN MARIANAS ISLANDS, PREPARATION OF ARTHROPOD SAMPLES, AND PREPARATION OF A REFERENCE COLLECTION. 00010869 Parent award context Parent award agency: Department of Defense · Department of the Army Parent award NAICS: 541715 Parent award performance state: CA Parent award description: SERDP PROJECT RC21-1034 View parent award on USAspending | — | $325,509 | Mar 14, 2024 | — – — |
| Subcontractor | Department of Commerce | THIS STATEMENT OF WORK CONCERNS THE PASSIVE MICROWAVE IMAGER BT €€Œ CSU FCDR (01B-15) AND THE GRIDDED CDR (01B-15A). HERE, €œCDR€Ͽ½ DENOTES THE SUITE OF SOURCE CODES, DOCUMENTATION, AND DATA SET. THE SCOPE OF WORK INCLUDES THE OPERATIONAL UPDATES (FORWARD PROCESSING) AND STEWARDSHIP SUPPORT OF THE OPERATIONAL CDR. ALL DELIVERABLES WILL BE PROVIDED TO NCEI. THE DATA PROVIDER WILL BE RESPONSIBLE FOR ADDRESSING ERRORS AND DISCREPANCIES FOUND IN THE CDR AND MUST COMPLY WITH THE CDRP€„¢S CONFIGURATION MANAGEMENT PROCESSES (SEE REFERENCE 5 FOR A PROCESS FLOW). THE DATA PROVIDER WILL BE RESPONSIBLE FOR MAINTAINING PASSIVE MICROWAVE IMAGER BT €€Œ CSU FCDR (01B-15) AND THE GRIDDED CDR (01B-15A) AT V02R00 UNLESS A CHANGE REQUEST TO TRANSITION TO A NEW VERSION IS APPROVED BY THE CDR PROGRAM€„¢S CHANGE CONTROL BOARD. PTS2-CSU-CDR Parent award context Parent award agency: Department of Commerce · National Oceanic and Atmospheric Administration Parent award NAICS: 541715 Parent award performance state: NC Parent award description: NCEI SCIENCE SUPPORT View parent award on USAspending | 1305M423DNEEA0014USAspending | $210,950 | Feb 4, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | PI: HONG QI, QOOLABS INC, 1915 ASTON AVE, CARLSBAD, CA 92008
I. BACKGROUND INFORMATION
GUINEA PIGS HAVE BEEN USED AS EXPERIMENTAL ANIMALS FOR CENTURIES. DUE TO THEIR BIOLOGICAL SIMILARITIES TO HUMANS, GUINEA PIGS WERE USED IN MANY FIELDS OF BIOMEDICAL RESEARCH, SUCH AS NUTRITIONAL RESEARCH, VACCINE RESEARCH AND DEVELOPMENT, HORMONAL STUDIES, AUDITORY SYSTEM STUDIES, AND INFECTIOUS DISEASE STUDIES. GUINEA PIGS ARE ESPECIALLY IMPORTANT IN TUBERCULOSIS RESEARCH. THE USEFULNESS OF GUINEA PIG AS A SMALL ANIMAL MODEL FOR BIOMEDICAL RESEARCH HAS BEEN CONSTRAINED BY THE LACK OF IMMUNOLOGICAL REAGENTS, PARTICULARLY FOR IMMUNOLOGICAL ANALYSIS. AFFINITY REAGENTS FOR IMMUNE SYSTEM OF GUINEA PIGS ARE OF GREAT NEED TO FACILITATE THE IMMUNOLOGICAL ANALYSIS USING THIS ANIMAL MODEL.
QOOLABS HAS DEVELOPED A ROBUST METHOD OF GENERATING RECOMBINANT RABBIT MONOCLONAL ANTIBODIES FROM PERIPHERAL BLOOD (QMAB‎¢ FOR QUICK MONOCLONAL ANTIBODY FROM BLOOD). USING QMAB TECHNOLOGY, QOOLABS WAS AWARDED AN SBIR CONTRACT PREVIOUSLY TO GENERATE RABBIT MONOCLONAL ANTIBODIES FOR SELECTED GUINEA PIG CYTOKINES. OVER 100 CLONES OF ANTIBODIES WERE GENERATED FOR DIFFERENT GUINEA PIG CYTOKINES. IN COLLABORATION WITH SEATTLE CHILDREN€„¢S RESEARCH INSTITUTE AND COLORADO STATE UNIVERSITY (CSU), MULTIPLE CLONES OF ANTIBODIES WERE VERIFIED FOR THEIR FUNCTION IN DETECTING ENDOGENOUS GUINEA PIG CYTOKINES. A LARGE NUMBER OF CLONES HAVE BEEN GENERATED AGAINST RECOMBINANT GUINEA PIG CYTOKINE IMMUNOGENS. THESE CLONES MUST BE DOWN SELECTED AND PAIRED TOGETHER TO GENERATE ASSAYS WITH CAPACITY TO QUANTIFY GUINEA PIG CYTOKINES. IN WORKING WITH CSU, QOOLABS WILL CONTRIBUTE TO IDENTIFYING THE MOST REACTIVE CLONES AND ESTABLISH FUNCTIONAL ANTIBODY PAIRS THAT CAN BE DEPLOYED IN ASSAYS. THIS WILL REQUIRE SHARING OF GUINEA PIG CELL-DERIVED SUPERNATANTS AND HARMONIZATION OF ASSAY CONDITIONS ACROSS CSU AND QOOLABS. CSU WILL THEN DEPLOY DEVELOPED ASSAYS IN THE GUINEA PIG MODEL OF TUBERCULOSIS.
IN ORDER TO ACCOMPLISH THE GOALS OF FURTHER CHARACTERIZING THESE ANTIBODIES AND USING THEM IN TB RESEARCH, THE REQUIREMENTS ARE TWO-FOLD: 1) LARGE QUANTITIES OF THESE ANTIBODIES ARE NEEDED; AND 2) ANTIBODY CLONES MUST BE SELECTED FOR BEST AFFINITY AGAINST SAMPLES CONTAINING THE BIOLOGICAL PROTEIN. IN THIS COLLABORATIVE EFFORT BETWEEN QOO LABS AND CSU, ENTITIES WILL CROSS-HARMONIZE STRATEGIES FOR PRODUCTION OF CYTOKINES FROM PRIMARY GUINEA PIG DERIVED CELLS, IDENTIFY THE APPROACH TO PAIR ANTIBODIES FOR DEVELOPMENT OF ELISA AND ELISPOT ASSAYS, THEN PRODUCE LARGE QUANTITIES OF THE BEST PERFORMING ANTIBODY CLONES FOR APPLICATION IN THE GUINEA PIG MODEL OF TUBERCULOSIS. OWING TO THE LACK OF IMMUNOLOGICAL REAGENTS SPECIFIC TO GUINEA PIG TARGETS, THIS COLLABORATIVE CONTRACT HARNESSES EXPERTISE IN ANTIBODY DEVELOPMENT AND CHARACTERIZATION (QOOLABS) AND EXPERTISE IN GUINEA PIG IMMUNOLOGY AND THE GUINEA PIG MODEL OF TUBERCULOSIS (CSU).
II. SCOPE
THIS PROJECT WILL FOCUS ON THE SELECTION AND PRODUCTION OF SELECTED RABBIT MONOCLONAL ANTIBODIES IN SUFFICIENT QUANTITIES TO SUPPORT THE RESEARCH NEEDS PROPOSED TO ESTABLISH THE KINETIC GUINEA PIG CYTOKINE RESPONSE TO INFECTION WITH M. TUBERCULOSIS.
III. OBJECTIVES
THIRTY-TWO (32) CLONES OF RABBIT MONOCLONAL ANTIBODIES SELECTED FOR PRIMARY TESTING. 5MG OF EACH ANTIBODY WILL BE PRODUCED AND PURIFIED. EACH ANTIBODY WILL BE BIOTINYLATED AT 1MG SCALE. TESTING WILL BE PERFORMED IN COLLABORATION BETWEEN CSU AND QOOLABS, USING CELL STIMULATION CONDITIONS AND CELL-DERIVED MATERIALS AS DEVELOPED UNDER THIS CONTRACT AT CSU. CSU WILL SHARE CELL
STIMULATION CONDITIONS AND SUPERNATANT GENERATED AT CSU TO CROSS-HARMONIZE EXPERIMENTAL APPROACHES BETWEEN CSU AND QOOLABS. UPON FURTHER TESTING, 22 CLONES WILL BE SELECTED. LARGE QUANTITIES, UP TO 200MG OF EACH SELECTED CLONE, WILL BE PRODUCED AND PURIFIED. ELISA AND ELISPOT TESTING OF ANTIBODY PAIRS WILL BE CONFERRED BETWEEN CSU AND QOOLABS TO GENERATE NOVEL CYTOKINE DETECTION ASSAYS FOR THE GUINEA PIG. IN ORDER TO ACCOMPLISH THIS 13242SUB Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: WA Parent award description: IMMUNE MECHANISMS OF PROTECTION AGAINST MYCOBACTERIUM TUBERCULOSIS CENTER (IMPAC-TB) View parent award on USAspending | — | $1,874,995 | Dec 31, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | THROUGH THE EXECUTION OF THIS CONTRACT, WE WILL EXAMINE BASIC INDUCTION OF INNATE AND ADAPTIVE IMMUNITY FROM VACCINATION, INCLUDING STUDIES THAT ADDRESS NTM INTERFERENCE, RNA DELIVERY, PRIME-BOOST REGIMENS (INCLUDING BCG PRE-EXPOSURE), TRANSCRIPTOMIC HOST SIGNATURES, PROTEOMICS, SYSTEMS BIOLOGY AND DURABLE IMMUNE MEMORY FOR THE FURTHER ADVANCEMENT OF THE EFFORT TO DESIGN AND EVALUATE AN EFFICACIOUS VACCINE AGAINST MYCOBACTERIUM TUBERCULOSIS.
OPTION 1 ACTIVITIES: EVALUATE OPTIMIZED M.TB VACCINE CANDIDATES FOR SAFETY, IMMUNOGENICITY AND EFFICACY IN MOUSE TB MODELS
SIX-WEEK OLD MALE AND FEMALE C57BL/6 AND CBA (CBA EXCLUSIVELY USED IN TASK 1.4 & 1.5) MICE WILL BE MAINTAINED IN THE BIOSAFETY LEVEL-III BIOENVIRONMENTAL HAZARDS BUILDING AT COLORADO STATE UNIVERSITY, AND WILL BE GIVEN STERILE WATER, MOUSE CHOW, BEDDING, AND ENRICHMENT FOR THE DURATION OF THE EXPERIMENTS. ALL EXPERIMENTAL PROTOCOLS WILL BE APPROVED BY THE ANIMAL CARE AND USAGE COMMITTEE OF COLORADO STATE UNIVERSITY AS PER THE DEFINED DELIVERABLE IN THE BASE PERIOD.
SOME OF THE HARVESTED SAMPLES IN OPTION 1 TASKS OUTLINED BELOW WILL BE DISTRIBUTED TO COLLABORATOR SITES. CSU WILL PROVIDE THESE SAMPLES TO COLLABORATORS AS NEEDED AND PREDETERMINED BY THE NEEDS OF SOPS. THIS WILL INCLUDE BUT NOT BE LIMITED TO: SERUM OR BLOOD FOR ENDPOINT ANTIBODY ELISAS (SCRI), SYSTEMS SEROLOGY (RAGON) AND TRANSCRIPTOMIC (FHCRC) ASSAYS ACROSS SPECIES. FURTHERMORE, DATA GENERATED IN THIS OPTION WILL BE TRANSFERRED TO CSU AND FHCRC SYSTEMS BIOLOGISTS IN THE CORRECT FORMAT, AS DEFINED IN THE BASE PERIOD, FOR INTEGRATED ANALYSIS. ITERATIVE ANALYSIS WILL INVOLVE PRECLINICAL BIOLOGISTS AND SYSTEMS BIOLOGISTS FOR OPTIMAL DATA INTEGRITY AND IMPACT.
MICE WILL BE PROPHYLACTICALLY VACCINATED ONCE WITH BCG [SUBCUTANEOUS OR INTRADERMAL] OR TWICE WITH ID93+GLA-SE [0.5 μG FUSION PROTEIN DELIVERED IN 5μG GLA STABLE EMULSION ADJUVANT INTRAMUSCULARLY]. CONTROL MICE WILL INJECTED WITH SALINE OR GLA-SE ALONE ON THE SAME REGIMEN AS ID93+GLA-SE. IN CHALLENGE STUDIES WE WILL INFECT GROUPS OF MICE (4 MALE AND 4 FEMALE, 8 TOTAL PER GROUP) BY LOW-DOSE AEROSOL (LDA, 50-100 BACTERIA INTO THE LUNGS) WITH ONE EXPERIMENT SUITE RECEIVING LABORATORY ISOLATE M.TB ERDMAN AND A SEPARATE SUITE RECEIVING CLINICAL ISOLATE M.TB HN878. FOR AEROSOL CHALLENGE, MICE ARE PLACED IN A GLAS-COL CIRCULAR [5-CHAMBER] STAINLESS STEEL CAGING SYSTEM WHICH IS THEN PLACED IN A CENTRAL CHAMBER AND SEALED BY A GASKET. AEROSOLIZED BACTERIA ARE GENERATED IN A NEBULIZER AND BLOWN THROUGH THE CENTRAL CHAMBER FOR 30-MINUTES, FOLLOWED BY CLEAN AIR AND BRIEF EXPOSURE TO ULTRA-VIOLET LIGHT.
TABLE 3: PRECLINICAL DESIGN FOR TASK 1.2 AND TASK 1.3 GROUP PRIME1 FIRST BOOST2 SECOND BOOST3 CHALLENGE4
1
BCG
SALINE
SALINE
LDA M.TB ERDMAN
2
BCG
ID93+GLA-SE
ID93+GLA-SE
3
SALINE
SALINE
SALINE
4
SALINE
ID93+GLA-SE
ID93+GLA-SE
5
SALINE
SALINE
SALINE
NO CHALLENGE
1 BCG DELIVERED I.D./S.C. AT THE BASE OF THE TAIL. 2 FIRST BOOST DELIVERED I.M. 120 DAYS POST PRIME IMMUNIZATION. 3 SECOND BOOST DELIVERED I.M. 56 DAYS POST FIRST BOOST. 4 CHALLENGE WITH A LDA M.TB ERDMAN OR M.TB HN878 56 DAYS POST SECOND BOOST.
TASK 1.2. EVALUATE IMMUNOGENICITY OF ID93+GLA-SE TB CANDIDATE VACCINE IN C57BL/6 MICE.
PRE-CHALLENGE IMMUNE PROFILE OF ID93+GLA-SE. PRE-CHALLENGE IMMUNOGENICITY ASSAYS OF C57BL/6 MICE (4 MALE AND 4 FEMALE, 8 TOTAL PER GROUP) IMMUNIZED WITH BCG, ID93+GLA-SE OR A COMBINATION WILL INCLUDE ADAPTIVE T CELL IMMUNITY USING WHOLE BLOOD OR PBMC (AS DETERMINED IN THE BASE PERIOD) 19 COLOR ICS AND ICS FROM THE SPLEEN, AND HUMORAL RESPONSES USING A SURROGATE B CELL ASSAY (BONE-MARROW PLASMA CELL ASSAY), AND SEROLOGIC ANALYSIS (INCLUDING ANTIBODY END POINT ASSAYS FOR CHARACTERIZATION OF ANTIBODY SUBTYPES/ISOTYPES). IN ADDITION TO WEIGHING MICE BEFORE AND DAILY FOR 1-WEEK FOLLOWING EACH IMMUNIZATION, NON-TERMINAL BLOOD WILL BE COLLECTED POST IMMUNIZATION FOR SERUM TO BE STORED FOR FUTURE BIOMARKER ANALYSIS (EG. CRP) AS MEASURES OF PRECLINICAL SAFETY.
ICS FOR T CELL PHENOTYPING 13221SUB Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: WA Parent award description: IMMUNE MECHANISMS OF PROTECTION AGAINST MYCOBACTERIUM TUBERCULOSIS CENTER (IMPAC-TB) View parent award on USAspending | — | $19,048 | Dec 31, 2023 | — – — |
| Subcontractor | Department of the Interior | PROVIDE RESEARCH AND ENGINEERING SERVICES IN SUPPORT OF BYTE RI SEQUENTIAL PHASE II 1194-SB Parent award context Parent award agency: Department of the Interior · Departmental Offices Parent award NAICS: 541715 Parent award performance state: NY Parent award description: STTR PHASE II CONTRACT WITH ASSURED INFORMATION SECURITY, INC. View parent award on USAspending | — | $148,492 | Dec 11, 2023 | — – — |
| Subcontractor | Department of Defense | THIS PROPOSAL WILL ASSESS THE THREAT ANTIGENICALLY NOVEL ANTHRAX CAUSING BACTERIA POSE TO THE AMERICAN WARFIGHTER BY VIRULENCE DETERMINATION IN A GUINEA PIG INFECTION MODEL. IT IS A COLLABORATIVE PROJECT BETWEEN UNIVERSITY OF FLORIDA, CSU AND THE US ARMY MEDICAL RESEARCH INSTITUTE FOR INFECTIOUS DISEASE. WE WILL THEN ESTABLISH STATUS OF STERNE VACCINE PROTECTIVE EFFICACY AGAINST THESE STRAINS. NEXT, WE WILL EVALUATE EFFICACY OF A NOVEL NON-PA (CRM-PGA CAPSULE) ANTHRAX VACCINE. FINALLY, WE WILL EVALUATE PROTECTIVE EFFICACY OF A NEW DUAL ANTIGEN CRM-PGA + PA VACCINE AGAINST ANTHRAX. IN TOTAL, THIS WORK WILL IDENTIFY NEW THREATS FROM EMERGING ANTHRAX PATHOGENS AND INVESTIGATE THE APPLICATION OF AN ADDITIONAL ANTHRAX ANTIGEN TO THE CURRENT MODEL. BY CREATING A NEW GENERATION OF BI-VALENT ANTHRAX VACCINE THAT TARGETS BOTH THE TOXIC AND BACTEREMIC MECHANISMS OF DISEASE, THE ODDS OF OVERCOMING AN ANTHRAX VACCINE VIA ANY SINGLE MECHANISM ARE CONSIDERABLY DIMINISHED. SUMMARY OF SPECIFIC TASKS TO BE CONDUCTED AT CSU: PERSONNEL AT UF WILL PROVIDE A PANEL OF B. ANTHRACIS STRAINS TO CSU AND BOWEN LAB PERSONNEL WILL PROPAGATE THEM AND PREPARE SPORES FOR USE IN ANIMAL EXPERIMENTS; CSU WILL EVALUATE THE VIRULENCE OF B. ANTHRACIS STRAINS IN UNVACCINATED GUINEA PIGS AND THEN DETERMINE THE PROTECTIVE EFFICACY OF STERNE VACCINATION AGAINST THE FOUR PANEL A STRAINS. SERUM COLLECTED FROM IMMUNIZED ANIMALS WILL BE PROVIDED TO UF FOR ANALYSIS OF IMMUNE RESPONSES; ADDITIONAL STRAINS OF ANTIGENICALLY NOVEL B. ANTHRACIS WILL BE PROVIDED TO CSU AND AGAIN, THE EFFICACY OF THE STERNE VACCINE WILL BE DETERMINED IN COMPARISON TO A STANDARD AMES STRAIN CHALLENGE; PERSONNEL AT USAMRIID SHALL PROVIDE B. ANTHRACIS POLY-D-GLUTAMIC ACID CAPSULE CONJUGATED WITH THE CARRIER PROTEIN CRM197 (CRM-PGA) FOR VACCINATION AND IMMUNOLOGICAL STUDIES AS NEEDED IN THE PROPOSAL. CSU SHALL USE CRM ALONE AND CRM-PGA AS THE TWO VACCINE CONDITIONS AND DETERMINE THE PROTECTIVE EFFICACY OF CRM-PGA VACCINATION AGAINST AMES AND MULTIPLE OTHER STRAINS OF B. ANTHRACIS FROM DIVERSE GEOGRAPHICAL LOCATIONS. SUB00002914-06 Parent award context Parent award agency: Department of Defense · Defense Threat Reduction Agency Parent award NAICS: 541715 Parent award performance state: FL Parent award description: RESEARCH AND DEVELOPMENT SERVICES FOR VIRULENCE AND PROTECTIVE EFFICACY OF VACCINES AGAINST ANTIGENICALLY NOVEL BACILLUS STRAINS View parent award on USAspending | — | $46,350 | Nov 15, 2023 | — – — |
| Subcontractor | Department of Defense | DEFENSE AGAINST BURKHOLDERIA PSEUDOMALLEI INFECTION: SUBUNIT VACCINE AND MONOCLONAL ANTIBODY/NANOBODY TECHNOLOGIES MA1638 Parent award context Parent award agency: Department of Defense · Defense Threat Reduction Agency Parent award NAICS: 541715 Parent award performance state: HI Parent award description: DEFENSE AGAINST BURKHOLDERIA PSEUDOMALLEI INFECTION: SUBUNIT VACCINE AND MONOCLONAL ANTIBODY/NANOBODY TECHNOLOGIES View parent award on USAspending | — | $257,811 | Oct 4, 2023 | — – — |
| Subcontractor | Department of the Interior | 40 POINTS IN THE NW AND UPPER COLORADO DISTRICT 50005/001 TO4 Parent award context Parent award agency: Department of the Interior · Bureau of Land Management Parent award NAICS: 541620 Parent award performance state: VA Parent award description: COLORADO LOTIC AIM TO 2024 View parent award on USAspending | 140L0618D0025USAspending | $151,913 | Oct 1, 2023 | — – — |
| Subcontractor | Department of Defense | PROVIDE RESEARCH AND ENGINEERING SERVICES IN SUPPORT OF AMP PROGRAM 1131-SA Parent award context Parent award agency: Department of Defense · Department of the Navy Parent award NAICS: 541715 Parent award performance state: NY Parent award description: RESEARCH IAW SOW: ASSURED MICROPATCHING (AMP). THIS DARPA EFFORT IS IN SUPPORT OF TECHNICAL AREA 3: EVALUATION (TA3). View parent award on USAspending | — | $229,087 | Sep 15, 2023 | — – — |
| Subcontractor | Department of Defense | NATIVE PLANT SEED COLLECTION 1000300000950 Parent award context Parent award agency: Department of Defense · Department of the Navy Parent award NAICS: 541690 Parent award performance state: GU Parent award description: IGF::OT::IGF FFP CONTRACT; GOVERNMENT OF JAPAN FUNDED PROJECT; TO PROVIDE SERVICES TO PERFORM NATIVE PLANT SEED COLLECTION, SALVAGE, STORAGE, AND NURSERY PROPAGATION FOR NATIVE LIMESTONE FOREST SPECIES AT THE NAVAL BASE GUAM TELECOMMUNICATIONS SITE (NBGTS), GUAM. View parent award on USAspending | N6274215D1822USAspending | $2,188,615 | Jul 20, 2023 | — – — |
| Subcontractor | Department of Defense | PROVIDE ENGINEERING SERVICES IN SUPPORT OF AMP 1131-SA Parent award context Parent award agency: Department of Defense · Department of the Navy Parent award NAICS: 541715 Parent award performance state: NY Parent award description: RESEARCH IAW SOW: ASSURED MICROPATCHING (AMP). THIS DARPA EFFORT IS IN SUPPORT OF TECHNICAL AREA 3: EVALUATION (TA3). View parent award on USAspending | — | $100,000 | Jun 29, 2023 | — – — |
| Subcontractor | Department of Defense | THIS PROPOSAL WILL ASSESS THE THREAT ANTIGENICALLY NOVEL ANTHRAX CAUSING BACTERIA POSE TO THE AMERICAN WARFIGHTER BY VIRULENCE DETERMINATION IN A GUINEA PIG INFECTION MODEL. IT IS A COLLABORATIVE PROJECT BETWEEN UNIVERSITY OF FLORIDA, CSU AND THE US ARMY MEDICAL RESEARCH INSTITUTE FOR INFECTIOUS DISEASE. WE WILL THEN ESTABLISH STATUS OF STERNE VACCINE PROTECTIVE EFFICACY AGAINST THESE STRAINS. NEXT, WE WILL EVALUATE EFFICACY OF A NOVEL NON-PA (CRM-PGA CAPSULE) ANTHRAX VACCINE. FINALLY, WE WILL EVALUATE PROTECTIVE EFFICACY OF A NEW DUAL ANTIGEN CRM-PGA + PA VACCINE AGAINST ANTHRAX. IN TOTAL, THIS WORK WILL IDENTIFY NEW THREATS FROM EMERGING ANTHRAX PATHOGENS AND INVESTIGATE THE APPLICATION OF AN ADDITIONAL ANTHRAX ANTIGEN TO THE CURRENT MODEL. BY CREATING A NEW GENERATION OF BI-VALENT ANTHRAX VACCINE THAT TARGETS BOTH THE TOXIC AND BACTEREMIC MECHANISMS OF DISEASE, THE ODDS OF OVERCOMING AN ANTHRAX VACCINE VIA ANY SINGLE MECHANISM ARE CONSIDERABLY DIMINISHED. SUMMARY OF SPECIFIC TASKS TO BE CONDUCTED AT CSU: PERSONNEL AT UF WILL PROVIDE A PANEL OF B. ANTHRACIS STRAINS TO CSU AND BOWEN LAB PERSONNEL WILL PROPAGATE THEM AND PREPARE SPORES FOR USE IN ANIMAL EXPERIMENTS; CSU WILL EVALUATE THE VIRULENCE OF B. ANTHRACIS STRAINS IN UNVACCINATED GUINEA PIGS AND THEN DETERMINE THE PROTECTIVE EFFICACY OF STERNE VACCINATION AGAINST THE FOUR PANEL A STRAINS. SERUM COLLECTED FROM IMMUNIZED ANIMALS WILL BE PROVIDED TO UF FOR ANALYSIS OF IMMUNE RESPONSES; ADDITIONAL STRAINS OF ANTIGENICALLY NOVEL B. ANTHRACIS WILL BE PROVIDED TO CSU AND AGAIN, THE EFFICACY OF THE STERNE VACCINE WILL BE DETERMINED IN COMPARISON TO A STANDARD AMES STRAIN CHALLENGE; PERSONNEL AT USAMRIID SHALL PROVIDE B. ANTHRACIS POLY-D-GLUTAMIC ACID CAPSULE CONJUGATED WITH THE CARRIER PROTEIN CRM197 (CRM-PGA) FOR VACCINATION AND IMMUNOLOGICAL STUDIES AS NEEDED IN THE PROPOSAL. CSU SHALL USE CRM ALONE AND CRM-PGA AS THE TWO VACCINE CONDITIONS AND DETERMINE THE PROTECTIVE EFFICACY OF CRM-PGA VACCINATION AGAINST AMES AND MULTIPLE OTHER STRAINS OF B. ANTHRACIS FROM DIVERSE GEOGRAPHICAL LOCATIONS. SUB00002914-04 Parent award context Parent award agency: Department of Defense · Defense Threat Reduction Agency Parent award NAICS: 541715 Parent award performance state: FL Parent award description: RESEARCH AND DEVELOPMENT SERVICES FOR VIRULENCE AND PROTECTIVE EFFICACY OF VACCINES AGAINST ANTIGENICALLY NOVEL BACILLUS STRAINS View parent award on USAspending | — | $100,000 | Jun 9, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | THROUGH THE EXECUTION OF THIS CONTRACT, WE WILL EXAMINE BASIC INDUCTION OF INNATE AND ADAPTIVE IMMUNITY FROM VACCINATION, INCLUDING STUDIES THAT ADDRESS NTM INTERFERENCE, RNA DELIVERY, PRIME-BOOST REGIMENS (INCLUDING BCG PRE-EXPOSURE), TRANSCRIPTOMIC HOST SIGNATURES, PROTEOMICS, SYSTEMS BIOLOGY AND DURABLE IMMUNE MEMORY FOR THE FURTHER ADVANCEMENT OF THE EFFORT TO DESIGN AND EVALUATE AN EFFICACIOUS VACCINE AGAINST MYCOBACTERIUM TUBERCULOSIS.
OPTION 3 ACTIVITIES: EVALUATE OPTIMIZED M.TB VACCINE CANDIDATES FOR SAFETY, IMMUNOGENICITY AND EFFICACY IN THE NHP MODEL OF TB
TASK 3.6 PROTEOMIC ANALYSIS OF NHP SAMPLES VALIDATING TRANSCRIPTOMIC RESULTS.
PROTEOMIC ANALYSIS ON A SUBSET OF SAMPLES GENERATED IN NONHUMAN PRIMATES IN OPTION 3. VALIDATION OF TRANSCRIPTOMICS RESULTS WILL BE PERFORMED BY TARGETED PROTEOMICS ON NONHUMAN PRIMATE (NHP) SAMPLES GENERATED BY UKHSA AND SENT TO CSU. MULTIPLE REACTION MONITORING €€Œ MASS SPECTROMETRY (MRM-MS) WILL BE USED TO DETECT AND QUANTIFY THE RELATIVE ABUNDANCE OF BIOMARKERS IDENTIFIED VIA RNASEQ AND NANOSTRING. THE TOP 20 TARGETS WILL BE SELECTED FOR VALIDATION. FIRST, A HOMOLOGY SEARCH ACROSS THE FOUR SPECIES WILL BE MADE WITH THE ULTIMATE GOAL OF SELECTING PEPTIDES WITH IDENTICAL SEQUENCE AMONG THE SPECIES. THREE PEPTIDES PER TARGET WILL BE INCLUDED TO DEVELOP AND OPTIMIZE MRM-MS FOR EACH OF THE TARGETS. A HEAVY LABELED PEPTIDE WILL BE CUSTOM MADE AND USED AS AN INTERNAL STANDARD TO FACILITATE DETECTION, QUANTIFICATION, AND REPRODUCIBILITY AMONG SAMPLES. THIS FINAL ASSAY WILL BE EVALUATED FOR LIMIT OF DETECTION (LOD), LIMIT OF QUANTIFICATION (LOQ) AND REPRODUCIBILITY. METHODS OPTIMIZED IN THE BASE PERIOD WILL BE USED TO PROCESS SAMPLES (REMOVING ALBUMIN AND IGG, WHICH INTERFERE WITH ANALYSIS). IT IS POSSIBLE THAT THE TOP 20 TARGETS MAY NOT PRESENT HIGH HOMOLOGY AMONG SPECIES. THIS WILL MAKE DIFFICULT TO CHOOSE A REPRESENTATIVE PEPTIDE FOR ALL SPECIES. IF WE FIND THIS TO BE THE CASE, WE WILL INCLUDE ONE UNIQUE PEPTIDE PER SPECIES PER TARGET. BECAUSE OF THE COSTS ASSOCIATED WITH THIS STRATEGY WE WILL REDUCE THE NUMBER OF TARGETS FOR VALIDATION TO A MAXIMUM OF 15. IT IS POSSIBLE THAT SOME OF THE TOP 20 TARGETS SELECTED VIA TRANSCRIPTOMICS MAY NOT TRANSLATE TO SIGNIFICANT DIFFERENCES AMONG GROUPS WHEN EVALUATED VIA PROTEOMICS. THIS MAY BE DUE TO A MULTITUDE OF FACTORS SUCH AS POST-TRANSLATIONAL MODIFICATIONS, LOCALIZATION OF PROTEINS, DEGRADATION BY INTERNAL PROTEASES, LOW STABILITY OF BOTH MRNA AND PROTEINS. IN ORDER TO COMPLEMENT THE TRANSCRIPTOMICS DATA, WE WILL USE THE SPIKEMIXTM CYTOKINES PANELS DEVELOPED DURING THE BASE PERIOD TO COMPARE THE DIFFERENT COHORTS WITH THE GOAL OF IDENTIFYING ADDITIONAL PROTEIN BIOMARKERS. THE SPIKEMIXTM CYTOKINES MAY ALLOW FOR THE DETECTION OF MORE THAN 80 NHP PRIMATE CYTOKINES.
TASK 3.7 COMPARE IMMUNE PROFILES IN NHP, SMALL ANIMAL MODELS AND HUMANS TO IDENTIFY CORRELATES OF PROTECTION.
SUBTASK 3.7.4 INTEGRATED ANALYSIS AND DYNAMICAL SYSTEMS MODELING OF EXPERIMENTAL IMMUNOLOGY DATA ACROSS ALL SPECIES
SYSTEMS BIOLOGY: INTEGRATED ANALYSIS AND DYNAMICAL SYSTEMS MODELING OF EXPERIMENTAL IMMUNOLOGY DATA. IN ORDER TO INTEGRATE PROTECTION AND IMMUNOLOGIC DATA FROM MICE AND GUINEA PIGS TO UNCOVER POTENTIAL CORRELATES OF PROTECTION IN TASK 3.7 WE WILL:
1. CONFIGURE A BROADER DEDICATED NETWORK DATABASE/COMPUTATIONAL SERVER, EXPANDING ON RESOURCES GENERATED IN THE BASE PERIOD.
2. ESTABLISH PROTOCOLS AND STANDARDIZED DOCUMENTATION FOR DATA COLLECTION AND PRE-PROCESSING FOR ALL THE EXPERIMENTS USING MICE AND GUINEA PIG MODELS
3. CONSTRUCT A RELATIONAL DATABASE (RDB) FOR THE PRIMARY DATA FROM MOUSE EXPERIMENTS.
4. DEVELOP A SINGLE-TYPE DATA DRIVEN ANALYSIS TOOLS FOR EACH EXPERIMENTAL DATA TYPE.
5. DEVELOP A BROADER DYNAMICAL SYSTEM MODEL FOR CELL MEDIATED IMMUNITY BASED ON THE AVAILABLE MOUSE VACCINATION AND TB INFECTION MODELS.
6. DEVELOP A DYNAMICAL SYSTEM MODEL FOR CELL MEDIATED IMMUNITY BASED ON THE AVAILABLE GUINEA PIG AND MOUSE VACCINATION AND TB INFECTION MO 13077SUB Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: WA Parent award description: IMMUNE MECHANISMS OF PROTECTION AGAINST MYCOBACTERIUM TUBERCULOSIS CENTER (IMPAC-TB) View parent award on USAspending | — | $315,184 | May 31, 2023 | — – — |
| Subcontractor | National Aeronautics and Space Administration | CHRISTOPHER O'DELL WILL BE RESPONSIBLE FOR COORDINATING THE EFFORT AT CSU FOR ALGORITHM DEVELOPMENT AND VALIDATION THROUGHOUT THE PROJECT. O'DELL WILL ALSO PROVIDE BASIC FEEDBACK TO LM ON ASSESSING INSTRUMENT CALIBRATION, BASED ON HIS EXTENSIVE EXPERIENCE WITH OCO AND OCO-2. 2017-40 Parent award context Parent award agency: National Aeronautics and Space Administration · National Aeronautics and Space Administration Parent award NAICS: 541712 Parent award performance state: OK Parent award description: IGF::OT::IGF GEOSTATIONARY CARBON CYCLE OBSERVATORY (GEOCARB) MISSION NASA HAS SELECTED A FIRST-OF-ITS-KIND EARTH SCIENCE MISSION THAT WILL EXTEND OUR NATION'S LEAD IN MEASURING KEY GREENHOUSE GASES AND VEGETATION HEALTH FROM SPACE TO ADVANCE OUR UNDERSTANDING OF EARTH'S NATURAL EXCHANGES OF CARBON BETWEEN THE LAND, ATMOSPHERE AND OCEAN. THE PRINCIPAL INVESTIGATOR (PI)-LED MISSION WILL LAUNCH ON A COMMERCIAL COMMUNICATIONS SATELLITE TO MAKE OBSERVATIONS OVER THE AMERICAS FROM AN ORBIT OF APPROXIMATELY 22,000 MILES (35,400 KILOMETERS) ABOVE THE EQUATOR. THE MISSION WAS COMPETITIVELY SELECTED FROM 15 PROPOSALS SUBMITTED TO THE AGENCY'S SECOND EARTH VENTURE - MISSION ANNOUNCEMENT OF OPPORTUNITY FOR SMALL ORBITAL INVESTIGATIONS OF THE EARTH SYSTEM. THE PRIMARY GOALS OF THE GEOCARB MISSION ARE TO MONITOR PLANT HEALTH AND VEGETATION STRESS THROUGHOUT THE AMERICAS, TO PROBE, IN UNPRECEDENTED DETAIL, THE NATURAL SOURCES, SINKS AND EXCHANGE PROCESSES THAT CONTROL CARBON DIOXIDE, CARBON MONOXIDE AND METHANE IN THE ATMOSPHERE, AND TO PROVIDE OBSERVATIONS AND DEMONSTRATE METHODS TO REALIZE A TRANSFORMATIONAL ADVANCE IN THE SCIENTIFIC UNDERSTANDING OF THE GLOBAL CARBON CYCLE. THE GEOCARB MISSION, A CATEGORY 3 MISSION (PER NPR 7120.5E, NASA SPACE FLIGHT PROGRAM AND PROJECT MANAGEMENT REQUIREMENTS) WITH A CLASS D PAYLOAD (PER NPR 8705.4, RISK CLASSIFICATION FOR NASA PAYLOADS), IS A SCIENCE INVESTIGATION WITH THE PRIMARY OBJECTIVE OF SIGNIFICANTLY IMPROVING KNOWLEDGE OF TERRESTRIAL FLUXES OF CO2 AND CH4 AT SCIENCE- AND POLICY-RELEVANT SCALES. THE GEOCARB MISSION UTILIZES A MULTI-CHANNEL SLIT-SCAN SPECTROMETER BASED INSTRUMENT THAT WILL MEASURE ABSORPTION SPECTRA IN SUNLIGHT REFLECTED FROM THE GROUND TO INFER THE ATMOSPHERE-COLUMN CONCENTRATIONS OF CO2, CH4, AND CARBON MONOXIDE (CO). THE INSTRUMENT WILL ALSO MEASURE SOLAR-INDUCED FLUORESCENCE (SIF), WHICH PROVIDES DIRECT INFORMATION ABOUT PHOTOSYNTHESIS. THE CONTRACTOR AND ITS TEAM MEMBERS WILL PERFORM THE FULL NASA LIFE CYCLE FORMULATION AND IMPLEMENTATION PHASES A THROUGH F. THE GEOCARB PROPOSAL WAS SELECTED UNDER THE NASA ANNOUNCEMENT OF OPPORTUNITY NNH15ZDA011O FOR THE EARTH VENTURE MISSION - 2 ELEMENT OF THE EARTH SYSTEM SCIENCE PATHFINDER PROGRAM OFFICES EARTH VENTURE LINE. View parent award on USAspending | — | $716,317 | May 23, 2023 | — – — |
| Subcontractor | Department of Defense | PROVIDE RESEARCH AND ENGINEERING SERVICES FOR AMP PROGRAM 1131-SA Parent award context Parent award agency: Department of Defense · Department of the Navy Parent award NAICS: 541715 Parent award performance state: NY Parent award description: RESEARCH IAW SOW: ASSURED MICROPATCHING (AMP). THIS DARPA EFFORT IS IN SUPPORT OF TECHNICAL AREA 3: EVALUATION (TA3). View parent award on USAspending | — | $410,851 | May 15, 2023 | — – — |
| Subcontractor | Department of Defense | IN SUPPORT OF AMP SUBCONTRACT PROVIDING RESEARCH SERVICES 1131-SA Parent award context Parent award agency: Department of Defense · Department of the Navy Parent award NAICS: 541715 Parent award performance state: NY Parent award description: RESEARCH IAW SOW: ASSURED MICROPATCHING (AMP). THIS DARPA EFFORT IS IN SUPPORT OF TECHNICAL AREA 3: EVALUATION (TA3). View parent award on USAspending | — | $91,194 | Mar 14, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | A CHALLENGE STUDY IN FERRETS. 36 FERRETS WILL BE IMMUNIZED TWICE WITH VACCINES AND ADJUVANT PROVIDED BY IDRI BEFORE BEING CHALLENGED WITH AN INTRANASAL INSTILLATION OF THE H5N1 STRAIN OF INFLUENZA. CSU-75A50121C00087 Parent award context Parent award agency: Department of Health and Human Services · Office of Assistant Secretary for Preparedness and Response Parent award NAICS: 541714 Parent award performance state: WA Parent award description: INFECTIOUS DISEASE RESEARCH INSTITUTE: R&D OF INTRANASAL ADMINISTRATION OF RNA VACCINES AGAINST RESPIRATORY PATHOGENS View parent award on USAspending | — | $111,115 | Mar 7, 2023 | — – — |
| Subcontractor | Department of Defense | DEFENSE AGAINST BURKHOLDERIA PSEUDOMALLEI INFECTION: SUBUNIT VACCINE AND MONOCLONAL ANTIBODY/NANOBODY TECHNOLOGIES MA1638 Parent award context Parent award agency: Department of Defense · Defense Threat Reduction Agency Parent award NAICS: 541715 Parent award performance state: HI Parent award description: DEFENSE AGAINST BURKHOLDERIA PSEUDOMALLEI INFECTION: SUBUNIT VACCINE AND MONOCLONAL ANTIBODY/NANOBODY TECHNOLOGIES View parent award on USAspending | — | $120,957 | Feb 14, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | THROUGH THE EXECUTION OF THIS CONTRACT, WE WILL EXAMINE BASIC INDUCTION OF INNATE AND ADAPTIVE IMMUNITY FROM VACCINATION, INCLUDING STUDIES THAT ADDRESS NTM INTERFERENCE, RNA DELIVERY, PRIME-BOOST REGIMENS (INCLUDING BCG PRE-EXPOSURE), TRANSCRIPTOMIC HOST SIGNATURES, PROTEOMICS, SYSTEMS BIOLOGY AND DURABLE IMMUNE MEMORY FOR THE FURTHER ADVANCEMENT OF THE EFFORT TO DESIGN AND EVALUATE AN EFFICACIOUS VACCINE AGAINST MYCOBACTERIUM TUBERCULOSIS.
OPTION 1 ACTIVITIES: EVALUATE OPTIMIZED M.TB VACCINE CANDIDATES FOR SAFETY, IMMUNOGENICITY AND EFFICACY IN MOUSE TB MODELS
SIX-WEEK OLD MALE AND FEMALE C57BL/6 AND CBA (CBA EXCLUSIVELY USED IN TASK 1.4 & 1.5) MICE WILL BE MAINTAINED IN THE BIOSAFETY LEVEL-III BIOENVIRONMENTAL HAZARDS BUILDING AT COLORADO STATE UNIVERSITY, AND WILL BE GIVEN STERILE WATER, MOUSE CHOW, BEDDING, AND ENRICHMENT FOR THE DURATION OF THE EXPERIMENTS. ALL EXPERIMENTAL PROTOCOLS WILL BE APPROVED BY THE ANIMAL CARE AND USAGE COMMITTEE OF COLORADO STATE UNIVERSITY AS PER THE DEFINED DELIVERABLE IN THE BASE PERIOD.
SOME OF THE HARVESTED SAMPLES IN OPTION 1 TASKS OUTLINED BELOW WILL BE DISTRIBUTED TO COLLABORATOR SITES. CSU WILL PROVIDE THESE SAMPLES TO COLLABORATORS AS NEEDED AND PREDETERMINED BY THE NEEDS OF SOPS. THIS WILL INCLUDE BUT NOT BE LIMITED TO: SERUM OR BLOOD FOR ENDPOINT ANTIBODY ELISAS (SCRI), SYSTEMS SEROLOGY (RAGON) AND TRANSCRIPTOMIC (FHCRC) ASSAYS ACROSS SPECIES. FURTHERMORE, DATA GENERATED IN THIS OPTION WILL BE TRANSFERRED TO CSU AND FHCRC SYSTEMS BIOLOGISTS IN THE CORRECT FORMAT, AS DEFINED IN THE BASE PERIOD, FOR INTEGRATED ANALYSIS. ITERATIVE ANALYSIS WILL INVOLVE PRECLINICAL BIOLOGISTS AND SYSTEMS BIOLOGISTS FOR OPTIMAL DATA INTEGRITY AND IMPACT.
MICE WILL BE PROPHYLACTICALLY VACCINATED ONCE WITH BCG [SUBCUTANEOUS OR INTRADERMAL] OR TWICE WITH ID93+GLA-SE [0.5 ÂÂΜG FUSION PROTEIN DELIVERED IN 5ÂÂΜG GLA STABLE EMULSION ADJUVANT INTRAMUSCULARLY]. CONTROL MICE WILL INJECTED WITH SALINE OR GLA-SE ALONE ON THE SAME REGIMEN AS ID93+GLA-SE. IN CHALLENGE STUDIES WE WILL INFECT GROUPS OF MICE (4 MALE AND 4 FEMALE, 8 TOTAL PER GROUP) BY LOW-DOSE AEROSOL (LDA, 50-100 BACTERIA INTO THE LUNGS) WITH ONE EXPERIMENT SUITE RECEIVING LABORATORY ISOLATE M.TB ERDMAN AND A SEPARATE SUITE RECEIVING CLINICAL ISOLATE M.TB HN878. FOR AEROSOL CHALLENGE, MICE ARE PLACED IN A GLAS-COL CIRCULAR [5-CHAMBER] STAINLESS STEEL CAGING SYSTEM WHICH IS THEN PLACED IN A CENTRAL CHAMBER AND SEALED BY A GASKET. AEROSOLIZED BACTERIA ARE GENERATED IN A NEBULIZER AND BLOWN THROUGH THE CENTRAL CHAMBER FOR 30-MINUTES, FOLLOWED BY CLEAN AIR AND BRIEF EXPOSURE TO ULTRA-VIOLET LIGHT.
TABLE 3: PRECLINICAL DESIGN FOR TASK 1.2 AND TASK 1.3
GROUP PRIME1 FIRST BOOST2 SECOND BOOST3 CHALLENGE4
1 BCG SALINE SALINE LDA M.TB ERDMAN
2 BCG ID93+GLA-SE ID93+GLA-SE
3 SALINE SALINE SALINE
4 SALINE ID93+GLA-SE ID93+GLA-SE
5 SALINE SALINE SALINE NO CHALLENGE
1 BCG DELIVERED I.D./S.C. AT THE BASE OF THE TAIL. 2 FIRST BOOST DELIVERED I.M. 120 DAYS POST PRIME IMMUNIZATION. 3 SECOND BOOST DELIVERED I.M. 56 DAYS POST FIRST BOOST. 4 CHALLENGE WITH A LDA M.TB ERDMAN OR M.TB HN878 56 DAYS POST SECOND BOOST.
TASK 1.2. EVALUATE IMMUNOGENICITY OF ID93+GLA-SE TB CANDIDATE VACCINE IN C57BL/6 MICE.
PRE-CHALLENGE IMMUNE PROFILE OF ID93+GLA-SE. PRE-CHALLENGE IMMUNOGENICITY ASSAYS OF C57BL/6 MICE (4 MALE AND 4 FEMALE, 8 TOTAL PER GROUP) IMMUNIZED WITH BCG, ID93+GLA-SE OR A COMBINATION WILL INCLUDE ADAPTIVE T CELL IMMUNITY USING WHOLE BLOOD OR PBMC (AS DETERMINED IN THE BASE PERIOD) 19 COLOR ICS AND ICS FROM THE SPLEEN, AND HUMORAL RESPONSES USING A SURROGATE B CELL ASSAY (BONE-MARROW PLASMA CELL ASSAY), AND SEROLOGIC ANALYSIS (INCLUDING ANTIBODY END POINT ASSAYS FOR CHARACTERIZATION OF ANTIBODY SUBTYPES/ISOTYPES). IN ADDITION TO WEIGHING MICE BEFORE AND DAILY FOR 1-WEEK FOLLOWING EACH IMMUNIZATION, NON-TERMINAL BLOOD WILL BE COLLECTED POST IMMUNIZATION FOR SERUM TO BE STORED FOR FUTURE BIOMARKER ANALYSIS (EG. CRP) AS MEASURES OF PRECLINICAL SAFETY.
ICS FOR T CELL 12964SUB Parent award context Parent award agency: Department of Health and Human Services · National Institutes of Health Parent award NAICS: 541715 Parent award performance state: WA Parent award description: IMMUNE MECHANISMS OF PROTECTION AGAINST MYCOBACTERIUM TUBERCULOSIS CENTER (IMPAC-TB) View parent award on USAspending | — | $902,300 | Dec 31, 2022 | — – — |
| Subcontractor | National Aeronautics and Space Administration | PERSONNEL, EQUIPMENT, AND
MATERIALS NECESSARY TO
ACCOMPLISH THE TASKS SET FORTH
IN
ATTACHMENT 4 OF ORIGINAL
SUBCONTRACT. 2017-40 Parent award context Parent award agency: National Aeronautics and Space Administration · National Aeronautics and Space Administration Parent award NAICS: 541712 Parent award performance state: OK Parent award description: IGF::OT::IGF GEOSTATIONARY CARBON CYCLE OBSERVATORY (GEOCARB) MISSION NASA HAS SELECTED A FIRST-OF-ITS-KIND EARTH SCIENCE MISSION THAT WILL EXTEND OUR NATION'S LEAD IN MEASURING KEY GREENHOUSE GASES AND VEGETATION HEALTH FROM SPACE TO ADVANCE OUR UNDERSTANDING OF EARTH'S NATURAL EXCHANGES OF CARBON BETWEEN THE LAND, ATMOSPHERE AND OCEAN. THE PRINCIPAL INVESTIGATOR (PI)-LED MISSION WILL LAUNCH ON A COMMERCIAL COMMUNICATIONS SATELLITE TO MAKE OBSERVATIONS OVER THE AMERICAS FROM AN ORBIT OF APPROXIMATELY 22,000 MILES (35,400 KILOMETERS) ABOVE THE EQUATOR. THE MISSION WAS COMPETITIVELY SELECTED FROM 15 PROPOSALS SUBMITTED TO THE AGENCY'S SECOND EARTH VENTURE - MISSION ANNOUNCEMENT OF OPPORTUNITY FOR SMALL ORBITAL INVESTIGATIONS OF THE EARTH SYSTEM. THE PRIMARY GOALS OF THE GEOCARB MISSION ARE TO MONITOR PLANT HEALTH AND VEGETATION STRESS THROUGHOUT THE AMERICAS, TO PROBE, IN UNPRECEDENTED DETAIL, THE NATURAL SOURCES, SINKS AND EXCHANGE PROCESSES THAT CONTROL CARBON DIOXIDE, CARBON MONOXIDE AND METHANE IN THE ATMOSPHERE, AND TO PROVIDE OBSERVATIONS AND DEMONSTRATE METHODS TO REALIZE A TRANSFORMATIONAL ADVANCE IN THE SCIENTIFIC UNDERSTANDING OF THE GLOBAL CARBON CYCLE. THE GEOCARB MISSION, A CATEGORY 3 MISSION (PER NPR 7120.5E, NASA SPACE FLIGHT PROGRAM AND PROJECT MANAGEMENT REQUIREMENTS) WITH A CLASS D PAYLOAD (PER NPR 8705.4, RISK CLASSIFICATION FOR NASA PAYLOADS), IS A SCIENCE INVESTIGATION WITH THE PRIMARY OBJECTIVE OF SIGNIFICANTLY IMPROVING KNOWLEDGE OF TERRESTRIAL FLUXES OF CO2 AND CH4 AT SCIENCE- AND POLICY-RELEVANT SCALES. THE GEOCARB MISSION UTILIZES A MULTI-CHANNEL SLIT-SCAN SPECTROMETER BASED INSTRUMENT THAT WILL MEASURE ABSORPTION SPECTRA IN SUNLIGHT REFLECTED FROM THE GROUND TO INFER THE ATMOSPHERE-COLUMN CONCENTRATIONS OF CO2, CH4, AND CARBON MONOXIDE (CO). THE INSTRUMENT WILL ALSO MEASURE SOLAR-INDUCED FLUORESCENCE (SIF), WHICH PROVIDES DIRECT INFORMATION ABOUT PHOTOSYNTHESIS. THE CONTRACTOR AND ITS TEAM MEMBERS WILL PERFORM THE FULL NASA LIFE CYCLE FORMULATION AND IMPLEMENTATION PHASES A THROUGH F. THE GEOCARB PROPOSAL WAS SELECTED UNDER THE NASA ANNOUNCEMENT OF OPPORTUNITY NNH15ZDA011O FOR THE EARTH VENTURE MISSION - 2 ELEMENT OF THE EARTH SYSTEM SCIENCE PATHFINDER PROGRAM OFFICES EARTH VENTURE LINE. View parent award on USAspending | — | $461,758 | Nov 28, 2022 | — – — |
| Subcontractor | Department of the Interior | 55 SITES PER YEAR FOR A BASE AND 1 OPTION YEAR IN THE NW DISTRICT, UPPER COLORADO DISTRICT, SW DISTRICT, AND ROCKY MOUNTAIN DISTRICTS. 50005/001 TO3 Parent award context Parent award agency: Department of the Interior · Bureau of Land Management Parent award NAICS: 541620 Parent award performance state: CO Parent award description: COLORADO LENTIC AIM View parent award on USAspending | 140L0618D0025USAspending | $485,708 | Oct 1, 2022 | — – — |
| Subcontractor | Department of Defense | DEFENSE AGAINST BURKHOLDERIA PSEUDOMALLEI INFECTION: SUBUNIT VACCINE AND MONOCLONAL ANTIBODY/NANOBODY TECHNOLOGIES MA1638 Parent award context Parent award agency: Department of Defense · Defense Threat Reduction Agency Parent award NAICS: 541715 Parent award performance state: HI Parent award description: DEFENSE AGAINST BURKHOLDERIA PSEUDOMALLEI INFECTION: SUBUNIT VACCINE AND MONOCLONAL ANTIBODY/NANOBODY TECHNOLOGIES View parent award on USAspending | — | $117,763 | Jun 14, 2022 | — – — |
| Subcontractor | National Aeronautics and Space Administration | SUBCONTRACTOR SHALL SUPPLY ALL
PERSONNEL, EQUIPMENT, AND
MATERIALS NECESSARY TO
ACCOMPLISH THE TASKS SET FORTH
IN
ATTACHMENT 4 OF ORIGINAL
SUBCONTRACT. 2017-40 Parent award context Parent award agency: National Aeronautics and Space Administration · National Aeronautics and Space Administration Parent award NAICS: 541712 Parent award performance state: OK Parent award description: IGF::OT::IGF GEOSTATIONARY CARBON CYCLE OBSERVATORY (GEOCARB) MISSION NASA HAS SELECTED A FIRST-OF-ITS-KIND EARTH SCIENCE MISSION THAT WILL EXTEND OUR NATION'S LEAD IN MEASURING KEY GREENHOUSE GASES AND VEGETATION HEALTH FROM SPACE TO ADVANCE OUR UNDERSTANDING OF EARTH'S NATURAL EXCHANGES OF CARBON BETWEEN THE LAND, ATMOSPHERE AND OCEAN. THE PRINCIPAL INVESTIGATOR (PI)-LED MISSION WILL LAUNCH ON A COMMERCIAL COMMUNICATIONS SATELLITE TO MAKE OBSERVATIONS OVER THE AMERICAS FROM AN ORBIT OF APPROXIMATELY 22,000 MILES (35,400 KILOMETERS) ABOVE THE EQUATOR. THE MISSION WAS COMPETITIVELY SELECTED FROM 15 PROPOSALS SUBMITTED TO THE AGENCY'S SECOND EARTH VENTURE - MISSION ANNOUNCEMENT OF OPPORTUNITY FOR SMALL ORBITAL INVESTIGATIONS OF THE EARTH SYSTEM. THE PRIMARY GOALS OF THE GEOCARB MISSION ARE TO MONITOR PLANT HEALTH AND VEGETATION STRESS THROUGHOUT THE AMERICAS, TO PROBE, IN UNPRECEDENTED DETAIL, THE NATURAL SOURCES, SINKS AND EXCHANGE PROCESSES THAT CONTROL CARBON DIOXIDE, CARBON MONOXIDE AND METHANE IN THE ATMOSPHERE, AND TO PROVIDE OBSERVATIONS AND DEMONSTRATE METHODS TO REALIZE A TRANSFORMATIONAL ADVANCE IN THE SCIENTIFIC UNDERSTANDING OF THE GLOBAL CARBON CYCLE. THE GEOCARB MISSION, A CATEGORY 3 MISSION (PER NPR 7120.5E, NASA SPACE FLIGHT PROGRAM AND PROJECT MANAGEMENT REQUIREMENTS) WITH A CLASS D PAYLOAD (PER NPR 8705.4, RISK CLASSIFICATION FOR NASA PAYLOADS), IS A SCIENCE INVESTIGATION WITH THE PRIMARY OBJECTIVE OF SIGNIFICANTLY IMPROVING KNOWLEDGE OF TERRESTRIAL FLUXES OF CO2 AND CH4 AT SCIENCE- AND POLICY-RELEVANT SCALES. THE GEOCARB MISSION UTILIZES A MULTI-CHANNEL SLIT-SCAN SPECTROMETER BASED INSTRUMENT THAT WILL MEASURE ABSORPTION SPECTRA IN SUNLIGHT REFLECTED FROM THE GROUND TO INFER THE ATMOSPHERE-COLUMN CONCENTRATIONS OF CO2, CH4, AND CARBON MONOXIDE (CO). THE INSTRUMENT WILL ALSO MEASURE SOLAR-INDUCED FLUORESCENCE (SIF), WHICH PROVIDES DIRECT INFORMATION ABOUT PHOTOSYNTHESIS. THE CONTRACTOR AND ITS TEAM MEMBERS WILL PERFORM THE FULL NASA LIFE CYCLE FORMULATION AND IMPLEMENTATION PHASES A THROUGH F. THE GEOCARB PROPOSAL WAS SELECTED UNDER THE NASA ANNOUNCEMENT OF OPPORTUNITY NNH15ZDA011O FOR THE EARTH VENTURE MISSION - 2 ELEMENT OF THE EARTH SYSTEM SCIENCE PATHFINDER PROGRAM OFFICES EARTH VENTURE LINE. View parent award on USAspending | — | $1,067,734 | Mar 2, 2022 | — – — |
| Subcontractor | Department of Defense | THIS PROPOSAL WILL ASSESS THE THREAT ANTIGENICALLY NOVEL ANTHRAX CAUSING BACTERIA POSE TO THE AMERICAN WARFIGHTER BY VIRULENCE DETERMINATION IN A GUINEA PIG INFECTION MODEL. IT IS A COLLABORATIVE PROJECT BETWEEN UNIVERSITY OF FLORIDA, CSU AND THE US ARMY MEDICAL RESEARCH INSTITUTE FOR INFECTIOUS DISEASE. WE WILL THEN ESTABLISH STATUS OF STERNE VACCINE PROTECTIVE EFFICACY AGAINST THESE STRAINS. NEXT, WE WILL EVALUATE EFFICACY OF A NOVEL NON-PA (CRM-PGA CAPSULE) ANTHRAX VACCINE. FINALLY, WE WILL EVALUATE PROTECTIVE EFFICACY OF A NEW DUAL ANTIGEN CRM-PGA + PA VACCINE AGAINST ANTHRAX. IN TOTAL, THIS WORK WILL IDENTIFY NEW THREATS FROM EMERGING ANTHRAX PATHOGENS AND INVESTIGATE THE APPLICATION OF AN ADDITIONAL ANTHRAX ANTIGEN TO THE CURRENT MODEL. BY CREATING A NEW GENERATION OF BI-VALENT ANTHRAX VACCINE THAT TARGETS BOTH THE TOXIC AND BACTEREMIC MECHANISMS OF DISEASE, THE ODDS OF OVERCOMING AN ANTHRAX VACCINE VIA ANY SINGLE MECHANISM ARE CONSIDERABLY DIMINISHED. SUMMARY OF SPECIFIC TASKS TO BE CONDUCTED AT CSU: PERSONNEL AT UF WILL PROVIDE A PANEL OF B. ANTHRACIS STRAINS TO CSU AND BOWEN LAB PERSONNEL WILL PROPAGATE THEM AND PREPARE SPORES FOR USE IN ANIMAL EXPERIMENTS; CSU WILL EVALUATE THE VIRULENCE OF B. ANTHRACIS STRAINS IN UNVACCINATED GUINEA PIGS AND THEN DETERMINE THE PROTECTIVE EFFICACY OF STERNE VACCINATION AGAINST THE FOUR PANEL A STRAINS. SERUM COLLECTED FROM IMMUNIZED ANIMALS WILL BE PROVIDED TO UF FOR ANALYSIS OF IMMUNE RESPONSES; ADDITIONAL STRAINS OF ANTIGENICALLY NOVEL B. ANTHRACIS WILL BE PROVIDED TO CSU AND AGAIN, THE EFFICACY OF THE STERNE VACCINE WILL BE DETERMINED IN COMPARISON TO A STANDARD AMES STRAIN CHALLENGE; PERSONNEL AT USAMRIID SHALL PROVIDE B. ANTHRACIS POLY-D-GLUTAMIC ACID CAPSULE CONJUGATED WITH THE CARRIER PROTEIN CRM197 (CRM-PGA) FOR VACCINATION AND IMMUNOLOGICAL STUDIES AS NEEDED IN THE PROPOSAL. CSU SHALL USE CRM ALONE AND CRM-PGA AS THE TWO VACCINE CONDITIONS AND DETERMINE THE PROTECTIVE EFFICACY OF CRM-PGA VACCINATION AGAINST AMES AND MULTIPLE OTHER STRAINS OF B. ANTHRACIS FROM DIVERSE GEOGRAPHICAL LOCATIONS. SUB00002914 Parent award context Parent award agency: Department of Defense · Defense Threat Reduction Agency Parent award NAICS: 541715 Parent award performance state: FL Parent award description: RESEARCH AND DEVELOPMENT SERVICES FOR VIRULENCE AND PROTECTIVE EFFICACY OF VACCINES AGAINST ANTIGENICALLY NOVEL BACILLUS STRAINS View parent award on USAspending | — | $249,884 | Jan 6, 2022 | — – — |
| Subcontractor | Department of Energy | 529045_COLORADO STATE UNIVERSITY - PO 529045 AGREEMENT FOR RESEARCH AND DEVELOPMENT 529045 Parent award context Parent award agency: Department of Energy · Department of Energy Parent award NAICS: 561210 Parent award performance state: NM Parent award description: IGF::CL::IGF COMPETITION FOR MANAGEMENT AND OPERATION OF LOS ALAMOS NATIONAL LABORATORY View parent award on USAspending | — | $279,260 | Oct 6, 2021 | — – — |
| Subcontractor | Department of Energy | 477628_COLORADO STATE UNIVERSITY - PO 477628 COLORADO STATE UNIVERSITY, VISUALIZING NANOSCALE SPATIO-TEMPORAL DYNAMICS IN SINGLE QUANTUM SYSTEMS 477628 Parent award context Parent award agency: Department of Energy · Department of Energy Parent award NAICS: 561210 Parent award performance state: NM Parent award description: IGF::CL::IGF COMPETITION FOR MANAGEMENT AND OPERATION OF LOS ALAMOS NATIONAL LABORATORY View parent award on USAspending | — | $167,000 | Oct 6, 2021 | — – — |
| Subcontractor | Department of Energy | 530739_COLORADO STATE UNIVERSITY - PO 530739 AGREEMENT FOR RESEARCH AND DEVELOPMENT 530739 Parent award context Parent award agency: Department of Energy · Department of Energy Parent award NAICS: 561210 Parent award performance state: NM Parent award description: IGF::CL::IGF COMPETITION FOR MANAGEMENT AND OPERATION OF LOS ALAMOS NATIONAL LABORATORY View parent award on USAspending | — | $60,000 | Oct 6, 2021 | — – — |
Contract vehicles are shown only when present in the source record. Linked award numbers and vehicles open the authoritative record on USAspending.gov.
Agencies supported
- Department of the InteriorGov-sourced
- Department of Health and Human ServicesGov-sourced
- Department of DefenseGov-sourced
- National Aeronautics and Space AdministrationGov-sourced
- Department of TransportationGov-sourced
Government-sourced data comes from SAM.gov, SBA and USAspending.gov and is attributed to its source. Items marked company-reported were provided by the company and are verified by FedSub only where labeled. FedSub is a private company and is not affiliated with SBA, GSA/SAM.gov, or any government agency.