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DENVER RESEARCH INSTITUTE
DENVER, CO, 80207
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Subcontracting experience
2 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 | THIS STATEMENT OF WORK (SOW) OUTLINES THE ACTIVITIES THAT THE SITES €€Œ DENVER RESEARCH INSTITUTE (AKA DRI, ADMINISTRATIVE/SUBCONTRACT SITE) AND ROCKY MOUNTAIN REGIONAL VA MEDICAL CENTER (AKA RMR-VAMC, EXPERIMENTAL WORK SITE) €€Œ WILL BE PERFORMING FOR THIS PROJECT. 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 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 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
TASK 1.4: EVALUATE POD EFFICACY WITH NTM (HN878 P1)
TO ENSURE THAT BIOLOGICAL RESULTS GENERATED IN THE VARIOUS CONSORTIUM LABS ARE COMPARABLE, WE WILL STANDARDIZE THE PRIMARY ASSAYS USED IN IMMUNOGENICITY ASSESSMENTS FOR EACH SPECIES. IN LINE WITH THE PROJECT GOALS TO DEVELOP A CROSS-SPECIES INTERROGATION PLATFORM, WE WILL HARMONIZE KEY ASSAYS ACROSS MULTIPLE SPECIES. SCRI WILL APPOINT AN OVERALL TASK LEADER TO COORDINATE AND OVERSEE THE WORK. ALL ASSAY STANDARD OPERATING PROCEDURES (SOP) WILL BE SHARED WITH A PRECLINICAL LABORATORY LEAD, DESIGNATED FOR EACH ASSAY, WHO WILL BE RESPONSIBLE FOR HARMONIZING. FINAL SOPS WILL BE SHARED AND LEAD ASSAY LABS WILL CONDUCT SIDE-BY-SIDE TRAINING SESSIONS, AS WELL AS MAINTAIN AND DISTRIBUTE COMMON REFERENCE STANDARDS AND REAGENTS, SUCH AS IDENTICAL STIMULATION ANTIGENS (BCG, PPD, SEB, PEPTIDE POOLS, MYCOBACTERIAL LYSATES AND BCG VACCINATION STRAIN (BCG AJ/BCG SSI). THESE REAGENTS WILL BE INCLUDED IN AN OPTIMIZED MULTICOLOR IMMUNOFLUORESCENCE PANEL (OMIP).
RMR-VAMC WILL USE THEIR EXPANSIVE STOCKS OF NTM ISOLATES TO GENERATE BATCHES OF A VARIETY OF APPROXIMATELY 5-10 NTM LIVE CULTURES, LYSATES AND CULTURE FILTRATES DURING OPTION 1. THESE REAGENTS WILL BE DISTRIBUTED TO COLLABORATOR SITES TO BE USED IN CROSS-SPECIES AND CROSS-SITE ASSAY VALIDATION AND STANDARDIZATION AS NEEDED. THESE REAGENTS WILL FURTHER BE USED TO EXECUTE ASSAYS EVALUATING THE EFFECTS OF NTM PRE-EXPOSURE IN MOUSE, GUINEA PIG, NONHUMAN PRIMATE (NHP) AND HUMAN SAMPLES, INCLUDING EVALUATING NTM-SPECIFIC ANTIBODY RESPONSES IN OPTIONS 1-4.
A SUMMARY REPORT OF ALL ACTIVITIES AND RESULTS FROM OPTION 1 WILL BE DRAFTED AND SUBMITTED TO NIAID FOR REVIEW AND APPROVAL. RMR-VAMC WILL PROVIDE ALL THE NECESSARY DATA AND INPUT REQUIRED FOR THE COMPLETION AND ACCEPTANCE OF THE FINAL REPORT FOR OPTION 1 ACTIVITIES.
CONTRACT PERIOD-SPECIFIC TASK TABLE OF DELIVERABLES:
DELIVERABLE TASK DESCRIPTION PERIOD OF PERFORMANCE DUE DATE
DUE THIS CONTRACT PERIOD 1.4 EVALUATE POD EFFICACY WITH NTM (HN878 P1) 8/1/2024 €€Œ 7/31/2025 7/31/2025
OPTION 3 ACTIVITIES: EVALUATE OPTIMIZED M.TB VACCINE CANDIDATES FOR SAFETY, IMMUNOGENICITY AND EFFICACY IN THE NHP MODEL OF TB
TASK 3.4: EX VIVO NHP MACROPHAGE STUDY
TASK 3.4: ANALYZE THE EFFECTS THE DIFFERENT VACCINE STRATEGIES HAVE ON NONHUMAN PRIMATE (NHP) MACROPHAGE CONTROL OF AN EX VIVO M.TB INFECTION. IN EX VIVO EXPERIMENTS, RMR-VAMC WILL DETERMINE WHAT EFFECTS THE DIFFERENT VACCINATION STRATEGIES IN NHP HAVE ON THE ABILITY OF THEIR MACROPHAGES TO CONTROL AN EX VIVO INFECTION AND ON MACROPHAGE EFFECTOR FUNCTIONS. IN GROUPS OF NHP WITH DIFFERENT VACCINE STRATEGIES, PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC) WILL BE OBTAINED POST-BOOST AND SENT P 13473SUB 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 | — | $136,373 | Nov 30, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | THIS STATEMENT OF WORK (SOW) OUTLINES THE ACTIVITIES THAT THE SITES €€Œ DENVER RESEARCH INSTITUTE (AKA DRI, ADMINISTRATIVE/SUBCONTRACT SITE) AND ROCKY MOUNTAIN REGIONAL VA MEDICAL CENTER (AKA RMR-VAMC, EXPERIMENTAL WORK SITE) €€Œ WILL BE PERFORMING FOR THIS PROJECT. 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 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 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
TASK 1.4: EVALUATE PREVENTION OF DISEASE (POD) EFFICACY WITH NTM (M.TB HN878 P1)
TO ENSURE THAT BIOLOGICAL RESULTS GENERATED IN THE VARIOUS CONSORTIUM LABS ARE COMPARABLE, WE WILL STANDARDIZE THE PRIMARY ASSAYS USED IN IMMUNOGENICITY ASSESSMENTS FOR EACH SPECIES. IN LINE WITH THE PROJECT GOALS TO DEVELOP A CROSS-SPECIES INTERROGATION PLATFORM, WE WILL HARMONIZE KEY ASSAYS ACROSS MULTIPLE SPECIES. SCRI WILL APPOINT AN OVERALL TASK LEADER TO COORDINATE AND OVERSEE THE WORK. ALL ASSAY STANDARD OPERATING PROCEDURES (SOP) WILL BE SHARED WITH A PRECLINICAL LABORATORY LEAD, DESIGNATED FOR EACH ASSAY, WHO WILL BE RESPONSIBLE FOR HARMONIZING. FINAL SOPS WILL BE SHARED AND LEAD ASSAY LABS WILL CONDUCT SIDE-BY-SIDE TRAINING SESSIONS, AS WELL AS MAINTAIN AND DISTRIBUTE COMMON REFERENCE STANDARDS AND REAGENTS, SUCH AS IDENTICAL STIMULATION ANTIGENS (BCG, PPD, SEB, PEPTIDE POOLS, MYCOBACTERIAL LYSATES AND BCG VACCINATION STRAIN (BCG AJ/BCG SSI). THESE REAGENTS WILL BE INCLUDED IN AN OPTIMIZED MULTICOLOR IMMUNOFLUORESCENCE PANEL (OMIP).
RMR-VAMC WILL USE THEIR EXPANSIVE STOCKS OF NTM ISOLATES TO GENERATE BATCHES OF A VARIETY OF APPROXIMATELY 5-10 NTM LIVE CULTURES, LYSATES AND CULTURE FILTRATES DURING OPTION 1. THESE REAGENTS WILL BE DISTRIBUTED TO COLLABORATOR SITES TO BE USED IN CROSS-SPECIES AND CROSS-SITE ASSAY VALIDATION AND STANDARDIZATION AS NEEDED. THESE REAGENTS WILL FURTHER BE USED TO EXECUTE ASSAYS EVALUATING THE EFFECTS OF NTM PRE-EXPOSURE IN MOUSE, GUINEA PIG, NONHUMAN PRIMATE (NHP) AND HUMAN SAMPLES, INCLUDING EVALUATING NTM-SPECIFIC ANTIBODY RESPONSES IN OPTIONS 1-4.
A SUMMARY REPORT OF ALL ACTIVITIES AND RESULTS FROM OPTION 1 WILL BE DRAFTED AND SUBMITTED TO NIAID FOR REVIEW AND APPROVAL. DRI/RMR-VAMC WILL PROVIDE ALL THE NECESSARY DATA AND INPUT REQUIRED FOR THE COMPLETION AND ACCEPTANCE OF THE FINAL REPORT FOR OPTION 1 ACTIVITIES.
CONTRACT PERIOD-SPECIFIC TASK TABLE OF DELIVERABLES:
DELIVERABLES TASK DESCRIPTION PERIOD OF PERFORMANCE DUE DATE
DUE THIS CONTRACT PERIOD 1.4 EVALUATE POD EFFICACY WITH NTM (M.TB HN878 P1) 8/1/2024 €€Œ 7/31/2025 7/31/2025
OPTION 3 ACTIVITIES: EVALUATE OPTIMIZED M.TB VACCINE CANDIDATES FOR SAFETY, IMMUNOGENICITY AND EFFICACY IN THE NHP MODEL OF TB
TASK 3.4: EX VIVO NHP MACROPHAGE STUDY
TASK 3.4: ANALYZE THE EFFECTS THE DIFFERENT VACCINE STRATEGIES HAVE ON NONHUMAN PRIMATE (NHP) MACROPHAGE CONTROL OF AN EX VIVO M.TB INFECTION. IN EX VIVO EXPERIMENTS, RMR-VAMC WILL DETERMINE WHAT EFFECTS THE DIFFERENT VACCINATION STRATEGIES IN NHP HAVE ON THE ABILITY OF THEIR MACROPHAGES TO CONTROL AN EX VIVO INFECTION AND ON MACROPHAGE EFFECTOR FUNCTIONS. IN GROUPS OF NHP WITH DIFFERENT VACCINE STRATEGIES, PBMC WILL BE OBTAINED POST-BOOST AND SENT 13477SUB 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 | — | $90,740 | Nov 30, 2024 | — – — |
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