← Back to search
STATENS SERUM INSTITUT
Doing business as STATENS SERUM INSTITUT
KOBENHAVN S, 2300
UnclaimedClaim this profile (free)
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 STATENS SERUM INSTITUT (SSI) WILL BE PERFORMING. 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 3 ACTIVITIES: EVALUATE OPTIMIZED M.TB VACCINE CANDIDATES FOR SAFETY, IMMUNOGENICITY AND EFFICACY IN THE NHP MODEL OF TB
TASK 3.1: NHP SAFETY AND EFFICACY AGAINST ULTRA-LOW DOSE AEROSOL (ULDA) M.TB ERDMAN
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 AS DESCRIBED BELOW (NTM MEGAPOOL, MTB300, MTB300-ID93, AND MTB300-M72), 15-MER PEPTIDES FOR ID93, COMPONENTS OF ID93, AND M72,AND UNSTIMULATED) AND BCG VACCINATION STRAIN (BCG AJ/BCG SSI). THESE REGENTS WILL BE INCLUDED IN AN OPTIMIZED MULTICOLOR IMMUNOFLUORESCENCE PANEL (OMIP).
FURTHERMORE, SSI WILL ASSIST IN THE ANALYSIS OF REACTIVITY OF PEPTIDES IN HUMAN AND ANIMAL MODELS IN ANTIGENICITY ASSAYS PRIOR TO IMPLEMENTATION IN OPTIONS 1-4.
A POOL OF 15-MER T CELL EPITOPES WHICH ARE FOUND IN DIVERSE NTMS BUT ABSENT FROM M.TB (PMID: 25548174) WILL BE SUPPLIED BY SSI IN THE OPTION 3 PERIOD TO COLLABORATOR LABS THAT REQUIRE THEM FOR IMMUNE PHENOTYPING ASSAYS. TAKING ADVANTAGE OF THE RECENTLY DEVELOPED APPROACH OF COMBINING A LARGE NUMBER OF EPITOPES IN ONE SINGLE POOL AS A "MEGAPOOL" (PMID: 27409590) WE COMBINE ALL EPITOPES IDENTIFIED IN THE PNAS STUDY TOGETHER WITH PEPTIDES IDENTIFIED BY OTHER MEMBERS OF OUR GROUP (PMID: 22046285). IN SUMMARY, LJI AND/OR SSI WILL PROVIDE:
A. MEGAPOOL OF 15-MER T CELL EPITOPES WHICH ARE FOUND IN DIVERSE NTMS BUT ABSENT FROM M.TB
B. MEGAPOOL OF M.TB -DERIVED EPITOPES (MTB300).
C. MEGAPOOL OF M.TB -DERIVED EPITOPES FROM WHICH ID93-DERIVED EPITOPES WERE OMITTED (MTB300-ID93).
D. MEGAPOOL OF M.TB-DERIVED EPITOPES FROM WHICH M72-DERIVED EPITOPES WERE OMITTED (MTB300-M72)
A SUMMARY REPORT OF ALL ACTIVITIES AND STANDARDIZED PROTOCOLS FROM THE OPTION 3 PERIOD WILL BE DRAFTED AND SUBMITTED TO NIAID FOR REVIEW AND APPROVAL. SSI WILL PROVIDE ALL THE NECESSARY DATA AND INPUT REQUIRED FOR THE COMPLETION AND ACCEPTANCE OF THE ANIMAL STUDY REPORT. SHIPMENT PLANNING AND DOCUMENTATION WILL BE PROVIDED FOR THE PEPTIDE POOLS TO BE USED IN PRECLINICAL (OPTION 3) NHP IMMUNOLOGIC STUDIES.
OPTION 4 ACTIVITIES: CONDUCT PHASE 1 CLINICAL TRIAL IN THE CONTROLLED HUMAN MYCOBACTERIAL CHALLENGE MODEL
TASK 4.3 CLINICAL FOLLOW-UP PHASE
TO ENSURE THAT BIOLOGICAL RESULTS GENERATED IN THE VARIOUS CONSORTIUM LABS ARE COMPARABLE, WE WILL STANDARDIZE THE PRIMARY ASSAYS USED IN SUB00002515 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 | — | $48,554 | Nov 3, 2025 | — – — |
| 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, PROTEOMICS, 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 3 ACTIVITIES: EVALUATE OPTIMIZED M.TB VACCINE CANDIDATES FOR SAFETY, IMMUNOGENICITY AND EFFICACY IN THE NHP MODEL OF TB
TASK 3.1: NHP SAFETY AND EFFICACY AGAINST ULTRA-LOW DOSE AEROSOL (ULDA) M.TB ERDMAN
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 AS DESCRIBED BELOW (NTM MEGAPOOL, MTB300, MTB300-ID93, AND MTB300-M72), 15-MER PEPTIDES FOR ID93, COMPONENTS OF ID93, AND M72,AND UNSTIMULATED) AND BCG VACCINATION STRAIN (BCG AJ/BCG SSI). THESE REGENTS WILL BE INCLUDED IN AN OPTIMIZED MULTICOLOR IMMUNOFLUORESCENCE PANEL (OMIP).
FURTHERMORE, SSI WILL ASSIST IN THE ANALYSIS OF REACTIVITY OF PEPTIDES IN HUMAN AND ANIMAL MODELS IN ANTIGENICITY ASSAYS PRIOR TO IMPLEMENTATION IN OPTIONS 1-4.
A POOL OF 15-MER T CELL EPITOPES WHICH ARE FOUND IN DIVERSE NTMS BUT ABSENT FROM M.TB (PMID: 25548174) WILL BE SUPPLIED BY SSI IN THE OPTION 3 PERIOD TO COLLABORATOR LABS THAT REQUIRE THEM FOR IMMUNE PHENOTYPING ASSAYS. TAKING ADVANTAGE OF THE RECENTLY DEVELOPED APPROACH OF COMBINING A LARGE NUMBER OF EPITOPES IN ONE SINGLE POOL AS A "MEGAPOOL" (PMID: 27409590) WE COMBINE ALL EPITOPES IDENTIFIED IN THE PNAS STUDY TOGETHER WITH PEPTIDES IDENTIFIED BY OTHER MEMBERS OF OUR GROUP (PMID: 22046285). IN SUMMARY, LJI AND/OR SSI WILL PROVIDE:
A. MEGAPOOL OF 15-MER T CELL EPITOPES WHICH ARE FOUND IN DIVERSE NTMS BUT ABSENT FROM M.TB
B. MEGAPOOL OF M.TB -DERIVED EPITOPES (MTB300).
C. MEGAPOOL OF M.TB -DERIVED EPITOPES FROM WHICH ID93-DERIVED EPITOPES WERE OMITTED (MTB300-ID93).
D. MEGAPOOL OF M.TB-DERIVED EPITOPES FROM WHICH M72-DERIVED EPITOPES WERE OMITTED (MTB300-M72)
A SUMMARY REPORT OF ALL ACTIVITIES AND STANDARDIZED PROTOCOLS FROM THE OPTION 3 PERIOD WILL BE DRAFTED AND SUBMITTED TO NIAID FOR REVIEW AND APPROVAL. SSI WILL PROVIDE ALL THE NECESSARY DATA AND INPUT REQUIRED FOR THE COMPLETION AND ACCEPTANCE OF THE ANIMAL STUDY REPORT. SHIPMENT PLANNING AND DOCUMENTATION WILL BE PROVIDED FOR THE PEPTIDE POOLS TO BE USED IN PRECLINICAL (OPTION 3) NHP IMMUNOLOGIC STUDIES.
OPTION 4 ACTIVITIES: CONDUCT PHASE 1 CLINICAL TRIAL IN THE CONTROLLED HUMAN MYCOBACTERIAL CHALLENGE MODEL
TASK 4.3 CLINICAL FOLLOW-UP PHASE
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 13494SUB 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 | — | $67,405 | Jan 31, 2025 | — – — |
Contract vehicles are shown only when present in the source record. Linked award numbers and vehicles open the authoritative record on USAspending.gov.
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.