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UNIVERSITY OF OXFORD
OXFORD, OX1 2
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Prime contracting experience
9 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 Office of the Assistant Secretary for Financial Resources | IN ORDER TO ENSURE A OF HIGHLY SKILLED MEDICAL AND SCIENTIFIC RESEARCHERS THE NIH HAS DEVELOPED THE NIH-WIDE GLOBAL DOCTORAL PARTNERSHIP (NGDP) CONSISTING OF A SET OF AFFILIATED DOCTORAL PROGRAMS DESIGNED TO ENHANCE THE TRAINING OF HIGHLY ACCOMPLISHE | — | $462,000 | Sep 25, 2026 | Sep 25, 2026 – Sep 24, 2027 |
| Prime | Department of Health and Human Services National Institutes of Health | AMBIS #2275457 - UNIVERSITY OF OXFORD NEW AND CONTINUING SCHOLARS OF THE OXFORD-CAMBRIDGE UNIVERSITY DOCTORAL PROGRAM 2025-2026 | — | $426,000 | Sep 29, 2025 | Sep 30, 2025 – Sep 29, 2026 |
| Prime | Department of Defense Department of the Air Force | TRANSPIRATION COOLING TO ENABLE SHARP LEADING EDGE TECHNOLOGY | — | $5,957,220 | Apr 22, 2025 | Dec 2, 2019 – Oct 21, 2024 |
| Prime | Department of Health and Human Services National Institutes of Health | UNIVERSITY OF OXFORD NEW & CONTINUING SCHOLARS OF THE OXFORD-CAMBRIDGE UNIVERSITY DOCTORAL PROGRAM | — | $510,000 | Sep 24, 2024 | Sep 24, 2024 – Sep 23, 2025 |
| Prime | Department of Defense Defense Threat Reduction Agency | MAHIDOL OXFORD RESEARCH TROPICAL UNIT VETERINARY LAB CAPACITY BUILDING | — | $8,450,393 | Jun 17, 2024 | Jun 23, 2021 – Jun 27, 2025 |
| Prime | Department of Health and Human Services Centers for Disease Control and Prevention | FY 21 BAA TOPIC 8 - CGPS (OXFORD) | — | $1,663,431 | May 31, 2024 | Jun 15, 2021 – Sep 14, 2022 |
| Prime | Department of Health and Human Services National Institutes of Health | UNIVERSITY OF OXFORD NEW & CONTINUING SCHOLARS OF THE OXFORD-CAMBRIDGE UNIVERSITY DOCTORAL PROGRAM | — | $498,000 | Aug 28, 2023 | Sep 1, 2023 – Aug 31, 2024 |
| Prime | Department of Health and Human Services National Institutes of Health | UNIVERSITY OF OXFORD NEW AND CONTINUING SCHOLARS OF THE OXFORD-CAMBRIDGE UNIVERSITY DOCTORAL PROGRAM | — | $506,000 | Sep 1, 2022 | Sep 14, 2022 – Sep 13, 2023 |
| Prime | Department of Health and Human Services Centers for Disease Control and Prevention | CLINICAL SAMPLE GONORRHOEA SEQUENCING TO COMBAT ANMTIBIOTIC RESISTANCE | — | $569,784 | Apr 30, 2022 | Sep 30, 2018 – Nov 29, 2019 |
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
9 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 OXFORD UNIVERSITY WILL BE PERFORMING THROUGHOUT THE PROPOSED TOTAL WORK PERIOD. NOTE THAT THE TASK NUMBERS BELOW REFLECT THE NUMBERING OF THE OVERALL ACTIVITIES IN THE PRIME CONTRACT.
OPTION 4 ACTIVITIES: CONDUCT TWO PHASE 1 CLINICAL TRIALS IN THE CONTROLLED HUMAN MYCOBACTERIAL CHALLENGE MODEL
USING AN ESTABLISHED MODEL OF AEROSOLIZED BCG DELIVERED TO THE LUNGS OF HUMANS, FOLLOWED BY BRONCHOSCOPIC ASSESSMENT OF MUCOSAL IMMUNITY, ASSESS VACCINE-MEDIATED PROTECTION FROM THIS CHALLENGE. TO DATE WE HAVE DELIVERED BCG VIA THE AEROSOL ROUTE TO OVER 65 VOLUNTEERS AND REPEATED THE DOSE ESCALATION FROM 1X104CFU - 1 X 107CFU BCG WITH NO SAFETY CONCERNS.
PROTOCOL SUMMARY OF THE TWO PHASE I CLINICAL TRIALS:
TB0441:
A CLINICAL CHALLENGE STUDY TO EVALUATE CONTROLLED HUMAN INFECTION WITH BCG ADMINISTERED BY THE AEROSOL INHALED ROUTE IN HISTORICALLY BCG-VACCINATED HEALTHY ADULT VOLUNTEERS
PHASE: 1 STUDY DURATION: 18 MONTHS
POPULATION: HEALTHY ADULT VOLUNTEERS, AGED 18-50. A TOTAL OF 12 SUBJECTS WILL BE ENROLLED. ESTIMATED TIME TO COMPLETE ENROLLMENT: APPROXIMATELY 9 MONTHS
SUBJECT PARTICIPATION DURATION: 6 MONTHS FROM ENROLLMENT NUMBER OF SITES: ONE (UNIVERSITY OF OXFORD/ OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST)
DESCRIPTION OF AGENTS OR INTERVENTION: BCG
STUDY OBJECTIVES: PRIMARY AIM IS TO QUANTIFY THE BCG RECOVERABLE FROM BRONCHIAL SAMPLES IN HEALTHY HISTORICALLY BCG-VACCINATED ADULT VOLUNTEERS
SECONDARY AIM IS TO EVALUATE THE HUMAN CLINICAL RESPONSE TO BCG CHALLENGE BY THE AEROSOL INHALED ROUTE IN HEALTHY, HISTORICALLY BCG-VACCINATED ADULT VOLUNTEERS
EXPLORATORY AIM IS TO IDENTIFY LABORATORY MARKERS OF THE IMMUNE RESPONSE THAT CORRELATE WITH THE LEVELS OF BCG RECOVERED FROM BRONCHIAL SAMPLES
STUDY OUTCOME MEASURES: PRIMARY OUTCOME MEASURE:
1. BCG RECOVERABLE FROM BRONCHIAL SAMPLE
BCG CULTURE BY MYCOBACTERIAL GROWTH INDICATOR TUBE; PCR QUANTIFICATION AND DNA STRIP ASSAY SPECIATION AS REQUIRED
[TIME FRAME: UP TO DAY 168]
SECONDARY OUTCOME MEASURE:
2. EVALUATION OF THE HUMAN CLINICAL RESPONSE TO BCG CHALLENGE
ACTIVELY AND PASSIVELY COLLECTED DATA ON ADVERSE EVENTS; DETAILED PARTICIPANT SYMPTOM PROFILES, LUNG FUNCTION TEST RESULTS
[TIME FRAME: UP TO DAY 168]
OTHER PRE-SPECIFIED OUTCOME MEASURES:
3. LABORATORY MARKERS OF THE IMMUNE RESPONSE THAT CORRELATE WITH THE LEVELS OF BCG RECOVERED FROM BRONCHIAL SAMPLES.
LABORATORY MARKERS OF INNATE AND ADAPTIVE IMMUNITY, INCLUDING EX-VIVO IFN- ELISPOT AND ELISA; RNA SEQUENCE ANALYSIS AND INTRACELLULAR CYTOKINE STAINING OF BLOOD. BCG CFU COUNTS, MGIT AND/ OR MOLECULAR DIAGNOSTICS ON INDUCED SPUTUM (IF PERFORMED) AND ON MATRIX FROM DUCKBILL MASK COLLECTION
[TIME FRAME: UP TO DAY 168]
DESCRIPTION OF STUDY GROUPS: GROUP 1: DOSE ESCALATION IN HISTORICALLY BCG VACCINATED VOLUNTEERS (N=12)
1A: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 104 CFU AEROSOL INHALED BCG
1B: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 105 CFU AEROSOL INHALED BCG
1C: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 106 CFU AEROSOL INHALED BCG
1D: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 107 CFU AEROSOL INHALED BCG
TB0451:
A PHASE I CLINICAL TRIAL TO EVALUATE (I) THE ADAPTIVE IMMUNE RESPONSE TO A CONTROLLED HUMAN INFECTION WITH AEROSOL BCG; AND (II) THE PROTECTIVE EFFICACY OF A PRIOR BCG VACCINATION AND/OR ID93+GLA-SE VACCINATION USING THIS MODEL
PHASE: 1 STUDY DURATION: 30 MONTHS
POPULATION: HEALTHY ADULT VOLUNTEERS, AGED 18-50. A TOTAL OF 48 SUBJECTS WILL BE ENROLLED. ESTIMATED TIME TO COMPLETE ENROLLMENT: APPROXIMATELY 21 MONTHS
SUBJECT PARTICIPATION DURATION: BCG ONLY: 2 MONTHS FROM ENROLLMENT
ID93 + GLA-SE + BCG: 6 MONTHS FROM ENROLLMENT NUMBER OF SITES: ONE (UNIVERSITY OF OXFORD/ OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST) WITH A POSSIBILITY OF A SECOND SITE TO AID RECRUITMENT (I.E SOUTHAMPTON, BIRMINGHAM)
DESCRIPTION OF AGENTS OR INTERVENTION: BCG
ID93 + GLA-SE (2 ΜG ID93, 5 ΜG GLA)
STUDY SUB00002492 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 | — | $205,272 | Sep 22, 2025 | — – — |
| Subcontractor | Department of Health and Human Services | THIS STATEMENT OF WORK (SOW) OUTLINES THE ACTIVITIES THAT OXFORD UNIVERSITY WILL BE PERFORMING THROUGHOUT THE PROPOSED TOTAL WORK PERIOD. NOTE THAT THE TASK NUMBERS BELOW REFLECT THE NUMBERING OF THE OVERALL ACTIVITIES IN THE PRIME CONTRACT.
OPTION 4 ACTIVITIES: CONDUCT TWO PHASE 1 CLINICAL TRIALS IN THE CONTROLLED HUMAN MYCOBACTERIAL CHALLENGE MODEL
USING AN ESTABLISHED MODEL OF AEROSOLIZED BCG DELIVERED TO THE LUNGS OF HUMANS, FOLLOWED BY BRONCHOSCOPIC ASSESSMENT OF MUCOSAL IMMUNITY, ASSESS VACCINE-MEDIATED PROTECTION FROM THIS CHALLENGE. TO DATE WE HAVE DELIVERED BCG VIA THE AEROSOL ROUTE TO OVER 65 VOLUNTEERS AND REPEATED THE DOSE ESCALATION FROM 1X104CFU - 1 X 107CFU BCG WITH NO SAFETY CONCERNS.
PROTOCOL SUMMARY OF THE TWO PHASE I CLINICAL TRIALS:
TB0441:
A CLINICAL CHALLENGE STUDY TO EVALUATE CONTROLLED HUMAN INFECTION WITH BCG ADMINISTERED BY THE AEROSOL INHALED ROUTE IN HISTORICALLY BCG-VACCINATED HEALTHY ADULT VOLUNTEERS
PHASE: 1 STUDY DURATION: 18 MONTHS
POPULATION: HEALTHY ADULT VOLUNTEERS, AGED 18-50. A TOTAL OF 12 SUBJECTS WILL BE ENROLLED. ESTIMATED TIME TO COMPLETE ENROLLMENT: APPROXIMATELY 9 MONTHS
SUBJECT PARTICIPATION DURATION: 6 MONTHS FROM ENROLLMENT NUMBER OF SITES: ONE (UNIVERSITY OF OXFORD/ OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST)
DESCRIPTION OF AGENTS OR INTERVENTION: BCG
STUDY OBJECTIVES: PRIMARY AIM IS TO QUANTIFY THE BCG RECOVERABLE FROM BRONCHIAL SAMPLES IN HEALTHY HISTORICALLY BCG-VACCINATED ADULT VOLUNTEERS
SECONDARY AIM IS TO EVALUATE THE HUMAN CLINICAL RESPONSE TO BCG CHALLENGE BY THE AEROSOL INHALED ROUTE IN HEALTHY, HISTORICALLY BCG-VACCINATED ADULT VOLUNTEERS
EXPLORATORY AIM IS TO IDENTIFY LABORATORY MARKERS OF THE IMMUNE RESPONSE THAT CORRELATE WITH THE LEVELS OF BCG RECOVERED FROM BRONCHIAL SAMPLES
STUDY OUTCOME MEASURES: PRIMARY OUTCOME MEASURE:
1. BCG RECOVERABLE FROM BRONCHIAL SAMPLE
BCG CULTURE BY MYCOBACTERIAL GROWTH INDICATOR TUBE; PCR QUANTIFICATION AND DNA STRIP ASSAY SPECIATION AS REQUIRED
[TIME FRAME: UP TO DAY 168]
SECONDARY OUTCOME MEASURE:
2. EVALUATION OF THE HUMAN CLINICAL RESPONSE TO BCG CHALLENGE
ACTIVELY AND PASSIVELY COLLECTED DATA ON ADVERSE EVENTS; DETAILED PARTICIPANT SYMPTOM PROFILES, LUNG FUNCTION TEST RESULTS
[TIME FRAME: UP TO DAY 168]
OTHER PRE-SPECIFIED OUTCOME MEASURES:
3. LABORATORY MARKERS OF THE IMMUNE RESPONSE THAT CORRELATE WITH THE LEVELS OF BCG RECOVERED FROM BRONCHIAL SAMPLES.
LABORATORY MARKERS OF INNATE AND ADAPTIVE IMMUNITY, INCLUDING EX-VIVO IFN-ïϿ½Â§ ELISPOT AND ELISA; RNA SEQUENCE ANALYSIS AND INTRACELLULAR CYTOKINE STAINING OF BLOOD AND BRONCHIAL SAMPLES. BCG CFU COUNTS, MGIT AND/ OR MOLECULAR DIAGNOSTICS ON INDUCED SPUTUM (IF PERFORMED) AND ON MATRIX FROM DUCKBILL MASK COLLECTION
[TIME FRAME: UP TO DAY 168]
DESCRIPTION OF STUDY GROUPS: GROUP 1: DOSE ESCALATION IN HISTORICALLY BCG VACCINATED VOLUNTEERS (N=12)
1A: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 104 CFU AEROSOL INHALED BCG
1B: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 105 CFU AEROSOL INHALED BCG
1C: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 106 CFU AEROSOL INHALED BCG
1D: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 107 CFU AEROSOL INHALED BCG
TB0451:
A PHASE I CLINICAL TRIAL TO EVALUATE (I) THE ADAPTIVE IMMUNE RESPONSE TO A CONTROLLED HUMAN INFECTION WITH AEROSOL BCG; AND (II) THE PROTECTIVE EFFICACY OF A PRIOR BCG VACCINATION AND/OR ID93+GLA-SE VACCINATION USING THIS MODEL
PHASE: 1 STUDY DURATION: 30 MONTHS
POPULATION: HEALTHY ADULT VOLUNTEERS, AGED 18-50. A TOTAL OF 48 SUBJECTS WILL BE ENROLLED. ESTIMATED TIME TO COMPLETE ENROLLMENT: APPROXIMATELY 21 MONTHS
SUBJECT PARTICIPATION DURATION: BCG ONLY: 2 MONTHS FROM ENROLLMENT
ID93 + GLA-SE + BCG: 6 MONTHS FROM ENROLLMENT NUMBER OF SITES: ONE (UNIVERSITY OF OXFORD/ OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST) WITH A POSSIBILITY OF A SECOND SITE TO AID RECRUITMENT (I.E SOUTHAMPTON, BIRMINGHAM)
DESCRIPTION OF AGENTS OR INTERVENTION: BCG
ID93 + GLA-SE 12873SUB 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 | — | $420,818 | Jan 31, 2025 | — – — |
| Subcontractor | Department of Health and Human Services | THIS STATEMENT OF WORK (SOW) OUTLINES THE ACTIVITIES THAT THE UNIVERSITY OF OXFORD (LEGAL ENTITY THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD) WILL BE PERFORMING THROUGHOUT THE PROPOSED TOTAL WORK PERIOD. NOTE THAT THE TASK NUMBERS BELOW REFLECT THE NUMBERING OF THE OVERALL ACTIVITIES IN THE PRIME CONTRACT.
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 4 ACTIVITIES: CONDUCT TWO PHASE 1 CLINICAL TRIALS IN THE CONTROLLED HUMAN MYCOBACTERIAL CHALLENGE MODEL
USING AN ESTABLISHED MODEL OF AEROSOLIZED BCG DELIVERED TO THE LUNGS OF HUMANS, FOLLOWED BY BRONCHOSCOPIC ASSESSMENT OF MUCOSAL IMMUNITY, ASSESS VACCINE-MEDIATED PROTECTION FROM THIS CHALLENGE. TO DATE WE HAVE DELIVERED BCG VIA THE AEROSOL ROUTE TO OVER 65 VOLUNTEERS AND REPEATED THE DOSE ESCALATION FROM 1X104CFU - 1 X 107CFU BCG. DUE TO MINOR SAFETY SIGNALS SEEN AT THE HIGHER DOSE OF BCG IN TB046 (A BCG REVACCINATION STUDY IN DIABETIC AND NON-DIABETIC ADULTS AT OXFORD PRECEDING TB045), TB045 WILL INSTEAD INCLUDE 1 X 106 CFU OF AEROSOL INHALED BCG
PROTOCOL SUMMARY OF THE TWO PHASE I CLINICAL TRIALS:
TB0441:
A CLINICAL CHALLENGE STUDY TO EVALUATE CONTROLLED HUMAN INFECTION WITH BCG ADMINISTERED BY THE AEROSOL INHALED ROUTE IN HISTORICALLY BCG-VACCINATED HEALTHY ADULT VOLUNTEERS
PHASE: 1 STUDY DURATION: 18 MONTHS
POPULATION: HEALTHY ADULT VOLUNTEERS, AGED 18-50. A TOTAL OF 12 SUBJECTS WILL BE ENROLLED. ESTIMATED TIME TO COMPLETE ENROLLMENT: APPROXIMATELY 9 MONTHS
SUBJECT PARTICIPATION DURATION: 6 MONTHS FROM ENROLLMENT NUMBER OF SITES: ONE (UNIVERSITY OF OXFORD/OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST)
DESCRIPTION OF AGENTS OR INTERVENTION: BCG
STUDY OBJECTIVES: PRIMARY AIM IS TO QUANTIFY THE BCG RECOVERABLE FROM BRONCHIAL SAMPLES IN HEALTHY HISTORICALLY BCG-VACCINATED ADULT VOLUNTEERS
SECONDARY AIM IS TO EVALUATE THE HUMAN CLINICAL RESPONSE TO BCG CHALLENGE BY THE AEROSOL INHALED ROUTE IN HEALTHY, HISTORICALLY BCG-VACCINATED ADULT VOLUNTEERS
EXPLORATORY AIM IS TO IDENTIFY LABORATORY MARKERS OF THE IMMUNE RESPONSE THAT CORRELATE WITH THE LEVELS OF BCG RECOVERED FROM BRONCHIAL SAMPLES
STUDY OUTCOME MEASURES: PRIMARY OUTCOME MEASURE:
1. BCG RECOVERABLE FROM BRONCHIAL SAMPLE
BCG CULTURE BY MYCOBACTERIAL GROWTH INDICATOR TUBE; PCR QUANTIFICATION AND DNA STRIP ASSAY SPECIATION AS REQUIRED
[TIME FRAME: UP TO DAY 168]
SECONDARY OUTCOME MEASURE:
2. EVALUATION OF THE HUMAN CLINICAL RESPONSE TO BCG CHALLENGE
ACTIVELY AND PASSIVELY COLLECTED DATA ON ADVERSE EVENTS; DETAILED PARTICIPANT SYMPTOM PROFILES, LUNG FUNCTION TEST RESULTS
[TIME FRAME: UP TO DAY 168]
OTHER PRE-SPECIFIED OUTCOME MEASURES:
3. LABORATORY MARKERS OF THE IMMUNE RESPONSE THAT CORRELATE WITH THE LEVELS OF BCG RECOVERED FROM BRONCHIAL SAMPLES.
LABORATORY MARKERS OF INNATE AND ADAPTIVE IMMUNITY, INCLUDING EX-VIVO IFN-ïϿ½Â§ ELISPOT AND ELISA; RNA SEQUENCE ANALYSIS AND INTRACELLULAR CYTOKINE STAINING OF BLOOD. BCG CFU COUNTS, MGIT AND/ OR MOLECULAR DIAGNOSTICS ON INDUCED SPUTUM (IF PERFORMED) AND ON MATRIX FROM DUCKBILL MASK COLLECTION
[TIME FRAME: UP TO DAY 168]
DESCRIPTION OF STUDY GROUPS: GROUP 1: DOSE ESCALATION IN HISTORICALLY BCG VACCINATED VOLUNTEERS (N=12)
1A: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 104 CFU AEROSOL INHALED BCG
1B: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 105 CFU AEROSOL INHALED BCG
1C: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 106 CFU AEROSOL INHALED BCG
1D: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 107 CFU AEROSOL INHALED BCG
TB0451:
A CLINICAL TRIAL EVALUATING THE SAFETY OF AN AEROSOL BCG CONTROLLED HUMAN INFECTION MODEL IN ASSESSING THE IMMUNOGENICITY OF HISTORICAL BCG VACCINATION AND VACCINATION WITH ID93+GLA-SE IN HEALTHY ADULT VOLUNTE 13426SUB 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 | — | $254,093 | Nov 30, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | OPTION 4 ACTIVITIES: CONDUCT TWO PHASE 1 CLINICAL TRIALS IN THE CONTROLLED HUMAN MYCOBACTERIAL CHALLENGE MODEL
USING AN ESTABLISHED MODEL OF AEROSOLIZED BCG DELIVERED TO THE LUNGS OF HUMANS, FOLLOWED BY BRONCHOSCOPIC ASSESSMENT OF MUCOSAL IMMUNITY, ASSESS VACCINE-MEDIATED PROTECTION FROM THIS CHALLENGE. TO DATE WE HAVE DELIVERED BCG VIA THE AEROSOL ROUTE TO OVER 65 VOLUNTEERS AND REPEATED THE DOSE ESCALATION FROM 1X104CFU - 1 X 107CFU BCG WITH NO SAFETY CONCERNS.
PROTOCOL SUMMARY OF THE TWO PHASE I CLINICAL TRIALS:
TB0441:
A CLINICAL CHALLENGE STUDY TO EVALUATE CONTROLLED HUMAN INFECTION WITH BCG ADMINISTERED BY THE AEROSOL INHALED ROUTE IN HISTORICALLY BCG-VACCINATED HEALTHY ADULT VOLUNTEERS
PHASE: 1 STUDY DURATION: 18 MONTHS
POPULATION: HEALTHY ADULT VOLUNTEERS, AGED 18-50. A TOTAL OF 12 SUBJECTS WILL BE ENROLLED. ESTIMATED TIME TO COMPLETE ENROLLMENT: APPROXIMATELY 9 MONTHS
SUBJECT PARTICIPATION DURATION: 6 MONTHS FROM ENROLLMENT NUMBER OF SITES: ONE (UNIVERSITY OF OXFORD/ OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST)
DESCRIPTION OF AGENTS OR INTERVENTION: BCG
STUDY OBJECTIVES: PRIMARY AIM IS TO QUANTIFY THE BCG RECOVERABLE FROM BRONCHIAL SAMPLES IN HEALTHY HISTORICALLY BCG-VACCINATED ADULT VOLUNTEERS
SECONDARY AIM IS TO EVALUATE THE HUMAN CLINICAL RESPONSE TO BCG CHALLENGE BY THE AEROSOL INHALED ROUTE IN HEALTHY, HISTORICALLY BCG-VACCINATED ADULT VOLUNTEERS
EXPLORATORY AIM IS TO IDENTIFY LABORATORY MARKERS OF THE IMMUNE RESPONSE THAT CORRELATE WITH THE LEVELS OF BCG RECOVERED FROM BRONCHIAL SAMPLES
STUDY OUTCOME MEASURES: PRIMARY OUTCOME MEASURE:
1. BCG RECOVERABLE FROM BRONCHIAL SAMPLE
BCG CULTURE BY MYCOBACTERIAL GROWTH INDICATOR TUBE; PCR QUANTIFICATION AND DNA STRIP ASSAY SPECIATION AS REQUIRED
[TIME FRAME: UP TO DAY 168]
SECONDARY OUTCOME MEASURE:
2. EVALUATION OF THE HUMAN CLINICAL RESPONSE TO BCG CHALLENGE
ACTIVELY AND PASSIVELY COLLECTED DATA ON ADVERSE EVENTS; DETAILED PARTICIPANT SYMPTOM PROFILES, LUNG FUNCTION TEST RESULTS
[TIME FRAME: UP TO DAY 168]
OTHER PRE-SPECIFIED OUTCOME MEASURES:
3. LABORATORY MARKERS OF THE IMMUNE RESPONSE THAT CORRELATE WITH THE LEVELS OF BCG RECOVERED FROM BRONCHIAL SAMPLES.
LABORATORY MARKERS OF INNATE AND ADAPTIVE IMMUNITY, INCLUDING EX-VIVO IFN-ïϿ½Â§ ELISPOT AND ELISA; RNA SEQUENCE ANALYSIS AND INTRACELLULAR CYTOKINE STAINING OF BLOOD. BCG CFU COUNTS, MGIT AND/ OR MOLECULAR DIAGNOSTICS ON INDUCED SPUTUM (IF PERFORMED) AND ON MATRIX FROM DUCKBILL MASK COLLECTION
[TIME FRAME: UP TO DAY 168]
DESCRIPTION OF STUDY GROUPS: GROUP 1: DOSE ESCALATION IN HISTORICALLY BCG VACCINATED VOLUNTEERS (N=12)
1A: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 104 CFU AEROSOL INHALED BCG
1B: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 105 CFU AEROSOL INHALED BCG
1C: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 106 CFU AEROSOL INHALED BCG
1D: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 107 CFU AEROSOL INHALED BCG
TB0451:
A PHASE I CLINICAL TRIAL TO EVALUATE (I) THE ADAPTIVE IMMUNE RESPONSE TO A CONTROLLED HUMAN INFECTION WITH AEROSOL BCG; AND (II) THE PROTECTIVE EFFICACY OF A PRIOR BCG VACCINATION AND/OR ID93+GLA-SE VACCINATION USING THIS MODEL
PHASE: 1 STUDY DURATION: 30 MONTHS
POPULATION: HEALTHY ADULT VOLUNTEERS, AGED 18-50. A TOTAL OF 48 SUBJECTS WILL BE ENROLLED. ESTIMATED TIME TO COMPLETE ENROLLMENT: APPROXIMATELY 21 MONTHS
SUBJECT PARTICIPATION DURATION: BCG ONLY: 2 MONTHS FROM ENROLLMENT
ID93 + GLA-SE + BCG: 6 MONTHS FROM ENROLLMENT NUMBER OF SITES: ONE (UNIVERSITY OF OXFORD/ OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST) WITH A POSSIBILITY OF A SECOND SITE TO AID RECRUITMENT (I.E SOUTHAMPTON, BIRMINGHAM)
DESCRIPTION OF AGENTS OR INTERVENTION: BCG
ID93 + GLA-SE (2 ÂÂΜG ID93, 5 ÂÂΜG GLA)
STUDY OBJECTIVES: PRIMARY AIM IS TO DETERMINE THE SAFETY BCG CHALLENGE BY THE AEROSOL INHALED ROUTE IN HEALTHY VOLUNTEERS AND RECENTLY ID93/GLA-SE-VACCINATED ADULT VOLUNTEERS
SECONDARY AIM IS TO DETERMINE THE PROTECTIVE EFFECT OF ID93 13234SUB 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 | — | $396,302 | Feb 29, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | OPTION 4 ACTIVITIES: CONDUCT TWO PHASE 1 CLINICAL TRIALS IN THE CONTROLLED HUMAN MYCOBACTERIAL CHALLENGE MODEL
USING AN ESTABLISHED MODEL OF AEROSOLIZED BCG DELIVERED TO THE LUNGS OF HUMANS, FOLLOWED BY BRONCHOSCOPIC ASSESSMENT OF MUCOSAL IMMUNITY, ASSESS VACCINE-MEDIATED PROTECTION FROM THIS CHALLENGE. TO DATE WE HAVE DELIVERED BCG VIA THE AEROSOL ROUTE TO OVER 65 VOLUNTEERS AND REPEATED THE DOSE ESCALATION FROM 1X104CFU - 1 X 107CFU BCG WITH NO SAFETY CONCERNS.
PROTOCOL SUMMARY OF THE TWO PHASE I CLINICAL TRIALS:
TB0441:
A CLINICAL CHALLENGE STUDY TO EVALUATE CONTROLLED HUMAN INFECTION WITH BCG ADMINISTERED BY THE AEROSOL INHALED ROUTE IN HISTORICALLY BCG-VACCINATED HEALTHY ADULT VOLUNTEERS
PHASE: 1 STUDY DURATION: 18 MONTHS
POPULATION: HEALTHY ADULT VOLUNTEERS, AGED 18-50. A TOTAL OF 12 SUBJECTS WILL BE ENROLLED. ESTIMATED TIME TO COMPLETE ENROLLMENT: APPROXIMATELY 9 MONTHS
SUBJECT PARTICIPATION DURATION: 6 MONTHS FROM ENROLLMENT NUMBER OF SITES: ONE (UNIVERSITY OF OXFORD/ OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST)
DESCRIPTION OF AGENTS OR INTERVENTION: BCG
STUDY OBJECTIVES: PRIMARY AIM IS TO QUANTIFY THE BCG RECOVERABLE FROM BRONCHIAL SAMPLES IN HEALTHY HISTORICALLY BCG-VACCINATED ADULT VOLUNTEERS
SECONDARY AIM IS TO EVALUATE THE HUMAN CLINICAL RESPONSE TO BCG CHALLENGE BY THE AEROSOL INHALED ROUTE IN HEALTHY, HISTORICALLY BCG-VACCINATED ADULT VOLUNTEERS
EXPLORATORY AIM IS TO IDENTIFY LABORATORY MARKERS OF THE IMMUNE RESPONSE THAT CORRELATE WITH THE LEVELS OF BCG RECOVERED FROM BRONCHIAL SAMPLES
STUDY OUTCOME MEASURES: PRIMARY OUTCOME MEASURE:
1. BCG RECOVERABLE FROM BRONCHIAL SAMPLE
BCG CULTURE BY MYCOBACTERIAL GROWTH INDICATOR TUBE; PCR QUANTIFICATION AND DNA STRIP ASSAY SPECIATION AS REQUIRED
[TIME FRAME: UP TO DAY 168]
SECONDARY OUTCOME MEASURE:
2. EVALUATION OF THE HUMAN CLINICAL RESPONSE TO BCG CHALLENGE
ACTIVELY AND PASSIVELY COLLECTED DATA ON ADVERSE EVENTS; DETAILED PARTICIPANT SYMPTOM PROFILES, LUNG FUNCTION TEST RESULTS
[TIME FRAME: UP TO DAY 168]
OTHER PRE-SPECIFIED OUTCOME MEASURES:
3. LABORATORY MARKERS OF THE IMMUNE RESPONSE THAT CORRELATE WITH THE LEVELS OF BCG RECOVERED FROM BRONCHIAL SAMPLES.
LABORATORY MARKERS OF INNATE AND ADAPTIVE IMMUNITY, INCLUDING EX-VIVO IFN-ïϿ½Â§ ELISPOT AND ELISA; RNA SEQUENCE ANALYSIS AND INTRACELLULAR CYTOKINE STAINING OF BLOOD. BCG CFU COUNTS, MGIT AND/ OR MOLECULAR DIAGNOSTICS ON INDUCED SPUTUM (IF PERFORMED) AND ON MATRIX FROM DUCKBILL MASK COLLECTION
[TIME FRAME: UP TO DAY 168]
DESCRIPTION OF STUDY GROUPS: GROUP 1: DOSE ESCALATION IN HISTORICALLY BCG VACCINATED VOLUNTEERS (N=12)
1A: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 104 CFU AEROSOL INHALED BCG
1B: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 105 CFU AEROSOL INHALED BCG
1C: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 106 CFU AEROSOL INHALED BCG
1D: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 107 CFU AEROSOL INHALED BCG
TB0451:
A PHASE I CLINICAL TRIAL TO EVALUATE (I) THE ADAPTIVE IMMUNE RESPONSE TO A CONTROLLED HUMAN INFECTION WITH AEROSOL BCG; AND (II) THE PROTECTIVE EFFICACY OF A PRIOR BCG VACCINATION AND/OR ID93+GLA-SE VACCINATION USING THIS MODEL
PHASE: 1 STUDY DURATION: 30 MONTHS
POPULATION: HEALTHY ADULT VOLUNTEERS, AGED 18-50. A TOTAL OF 48 SUBJECTS WILL BE ENROLLED. ESTIMATED TIME TO COMPLETE ENROLLMENT: APPROXIMATELY 21 MONTHS
SUBJECT PARTICIPATION DURATION: BCG ONLY: 2 MONTHS FROM ENROLLMENT
ID93 + GLA-SE + BCG: 6 MONTHS FROM ENROLLMENT NUMBER OF SITES: ONE (UNIVERSITY OF OXFORD/ OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST) WITH A POSSIBILITY OF A SECOND SITE TO AID RECRUITMENT (I.E SOUTHAMPTON, BIRMINGHAM)
DESCRIPTION OF AGENTS OR INTERVENTION: BCG
ID93 + GLA-SE (2 ÂÂΜG ID93, 5 ÂÂΜG GLA)
STUDY OBJECTIVES: PRIMARY AIM IS TO DETERMINE THE SAFETY BCG CHALLENGE BY THE AEROSOL INHALED ROUTE IN HEALTHY VOLUNTEERS AND RECENTLY ID93/GLA-SE-VACCINATED ADULT VOLUNTEERS
SECONDARY AIM IS TO DETERMINE THE PROTECTIVE EFFECT OF ID93 13222SUB 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 | — | $26,105 | Jan 31, 2024 | — – — |
| Subcontractor | Department of Health and Human Services | OPTION 4 ACTIVITIES: CONDUCT TWO PHASE 1 CLINICAL TRIALS IN THE CONTROLLED HUMAN MYCOBACTERIAL CHALLENGE MODEL
USING AN ESTABLISHED MODEL OF AEROSOLIZED BCG DELIVERED TO THE LUNGS OF HUMANS, FOLLOWED BY BRONCHOSCOPIC ASSESSMENT OF MUCOSAL IMMUNITY, ASSESS VACCINE-MEDIATED PROTECTION FROM THIS CHALLENGE. TO DATE WE HAVE DELIVERED BCG VIA THE AEROSOL ROUTE TO OVER 65 VOLUNTEERS AND REPEATED THE DOSE ESCALATION FROM 1X104CFU - 1 X 107CFU BCG WITH NO SAFETY CONCERNS.
PROTOCOL SUMMARY OF THE TWO PHASE I CLINICAL TRIALS:
TB0441:
A CLINICAL CHALLENGE STUDY TO EVALUATE CONTROLLED HUMAN INFECTION WITH BCG ADMINISTERED BY THE AEROSOL INHALED ROUTE IN HISTORICALLY BCG-VACCINATED HEALTHY ADULT VOLUNTEERS
PHASE: 1 STUDY DURATION: 18 MONTHS
POPULATION: HEALTHY ADULT VOLUNTEERS, AGED 18-50. A TOTAL OF 12 SUBJECTS WILL BE ENROLLED. ESTIMATED TIME TO COMPLETE ENROLLMENT: APPROXIMATELY 9 MONTHS
SUBJECT PARTICIPATION DURATION: 6 MONTHS FROM ENROLLMENT NUMBER OF SITES: ONE (UNIVERSITY OF OXFORD/ OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST)
DESCRIPTION OF AGENTS OR INTERVENTION: BCG
STUDY OBJECTIVES: PRIMARY AIM IS TO QUANTIFY THE BCG RECOVERABLE FROM BRONCHIAL SAMPLES IN HEALTHY HISTORICALLY BCG-VACCINATED ADULT VOLUNTEERS
SECONDARY AIM IS TO EVALUATE THE HUMAN CLINICAL RESPONSE TO BCG CHALLENGE BY THE AEROSOL INHALED ROUTE IN HEALTHY, HISTORICALLY BCG-VACCINATED ADULT VOLUNTEERS
EXPLORATORY AIM IS TO IDENTIFY LABORATORY MARKERS OF THE IMMUNE RESPONSE THAT CORRELATE WITH THE LEVELS OF BCG RECOVERED FROM BRONCHIAL SAMPLES
STUDY OUTCOME MEASURES: PRIMARY OUTCOME MEASURE:
1. BCG RECOVERABLE FROM BRONCHIAL SAMPLE
BCG CULTURE BY MYCOBACTERIAL GROWTH INDICATOR TUBE; PCR QUANTIFICATION AND DNA STRIP ASSAY SPECIATION AS REQUIRED
[TIME FRAME: UP TO DAY 168]
SECONDARY OUTCOME MEASURE:
2. EVALUATION OF THE HUMAN CLINICAL RESPONSE TO BCG CHALLENGE
ACTIVELY AND PASSIVELY COLLECTED DATA ON ADVERSE EVENTS; DETAILED PARTICIPANT SYMPTOM PROFILES, LUNG FUNCTION TEST RESULTS
[TIME FRAME: UP TO DAY 168]
OTHER PRE-SPECIFIED OUTCOME MEASURES:
3. LABORATORY MARKERS OF THE IMMUNE RESPONSE THAT CORRELATE WITH THE LEVELS OF BCG RECOVERED FROM BRONCHIAL SAMPLES.
LABORATORY MARKERS OF INNATE AND ADAPTIVE IMMUNITY, INCLUDING EX-VIVO IFN-ïϿ½Â§ ELISPOT AND ELISA; RNA SEQUENCE ANALYSIS AND INTRACELLULAR CYTOKINE STAINING OF BLOOD AND BRONCHIAL SAMPLES. BCG CFU COUNTS, MGIT AND/ OR MOLECULAR DIAGNOSTICS ON INDUCED SPUTUM (IF PERFORMED) AND ON MATRIX FROM DUCKBILL MASK COLLECTION
[TIME FRAME: UP TO DAY 168]
DESCRIPTION OF STUDY GROUPS: GROUP 1: DOSE ESCALATION IN HISTORICALLY BCG VACCINATED VOLUNTEERS (N=12)
1A: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 104 CFU AEROSOL INHALED BCG
1B: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 105 CFU AEROSOL INHALED BCG
1C: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 106 CFU AEROSOL INHALED BCG
1D: 3 HISTORICALLY BCG VACCINATED VOLUNTEERS WILL RECEIVE 1 X 107 CFU AEROSOL INHALED BCG
TB0451:
A PHASE I CLINICAL TRIAL TO EVALUATE (I) THE ADAPTIVE IMMUNE RESPONSE TO A CONTROLLED HUMAN INFECTION WITH AEROSOL BCG; AND (II) THE PROTECTIVE EFFICACY OF A PRIOR BCG VACCINATION AND/OR ID93+GLA-SE VACCINATION USING THIS MODEL
PHASE: 1 STUDY DURATION: 30 MONTHS
POPULATION: HEALTHY ADULT VOLUNTEERS, AGED 18-50. A TOTAL OF 48 SUBJECTS WILL BE ENROLLED. ESTIMATED TIME TO COMPLETE ENROLLMENT: APPROXIMATELY 21 MONTHS
SUBJECT PARTICIPATION DURATION: BCG ONLY: 2 MONTHS FROM ENROLLMENT
ID93 + GLA-SE + BCG: 6 MONTHS FROM ENROLLMENT NUMBER OF SITES: ONE (UNIVERSITY OF OXFORD/ OXFORD UNIVERSITY HOSPITALS NHS FOUNDATION TRUST) WITH A POSSIBILITY OF A SECOND SITE TO AID RECRUITMENT (I.E SOUTHAMPTON, BIRMINGHAM)
DESCRIPTION OF AGENTS OR INTERVENTION: BCG
ID93 + GLA-SE (2 ÂÂΜG ID93, 5 ÂÂΜG GLA)
STUDY OBJECTIVES: PRIMARY AIM IS TO DETERMINE THE SAFETY BCG CHALLENGE BY THE AEROSOL INHALED ROUTE IN HEALTHY VOLUNTEERS AND RECENTLY ID93/GLA-SE-VACCINATED ADULT VOLUNTEERS
SECONDARY AIM IS TO DETERMINE THE PROT 12873SUB 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 | — | $448,171 | Jun 30, 2023 | — – — |
| Subcontractor | Department of Health and Human Services | FOLLOWING ON FROM A SUCCESSFUL LEAD OPTIMIZATION STAGE, THE OXFORD UNIVERSITY JENNER INSTITUTE’S GONORRHEA VACCINE CANDIDATE, GONOVAC, HAS TRANSITIONED INTO OPTION 1, THE IND-ENABLING/PRECLINICAL STAGE WHICH HAS THE OVERALL AIM OF COMPLETING TOXICOLOGY STUDIES AND PRODUCING GMP LOTS OF OUR NOMV GONOCOCCAL VACCINE READY FOR PHASE I CLINICAL STUDIES IN OPTION 2. GMP MASTER CELL BANK PRODUCTION AND RELEASE WILL BE THE FIRST SUCH ACTIVITY. AT THE SAME TIME, OUR UPSTREAM AND DOWNSTREAM PRODUCTION PROCESSES WILL BE SCALED UP PRIOR TO GMP-LIKE ENGINEERING RUNS OF DRUG SUBSTANCE/DRUG PRODUCT (DS/DP) WHICH WILL BE USED FOR FORMAL TOXICOLOGY STUDIES AND STABILITY TESTING. AS A FINAL STAGE, GMP GRADE DS/DP WILL BE PRODUCED FOLLOWED BY VIALING OF DP. KC3403 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: MA Parent award description: CARB-X GLOBAL ANTIBACTERIAL ACCELERATOR OTA View parent award on USAspending | — | $626,602 | Nov 29, 2022 | — – — |
| Subcontractor | Department of Health and Human Services | OPTION 4 ACTIVITIES: CONDUCT TWO PHASE 1 CLINICAL TRIALS IN THE CONTROLLED HUMAN MYCOBACTERIAL CHALLENGE MODEL
USING AN ESTABLISHED MODEL OF AEROSOLIZED BCG DELIVERED TO THE LUNGS OF HUMANS, FOLLOWED BY BRONCHOSCOPIC ASSESSMENT OF MUCOSAL IMMUNITY, ASSESS VACCINE-MEDIATED PROTECTION FROM THIS CHALLENGE. TO DATE WE HAVE DELIVERED BCG VIA THE AEROSOL ROUTE TO OVER 65 VOLUNTEERS AND REPEATED THE DOSE ESCALATION FROM 1X104CFU - 1 X 107CFU BCG WITH NO SAFETY CONCERNS.
PROTOCOL SUMMARY OF THE TWO PHASE I CLINICAL TRIALS:
TB0441: A CLINICAL CHALLENGE STUDY TO EVALUATE CONTROLLED HUMAN INFECTION WITH BCG ADMINISTERED BY THE AEROSOL INHALED ROUTE IN HISTORICALLY BCG-VACCINATED HEALTHY ADULT VOLUNTEERS
TB0451: A PHASE I CLINICAL TRIAL TO EVALUATE (I) THE ADAPTIVE IMMUNE RESPONSE TO A CONTROLLED HUMAN INFECTION WITH AEROSOL BCG; AND (II) THE PROTECTIVE EFFICACY OF A PRIOR BCG VACCINATION AND/OR ID93+GLA-SE VACCINATION USING THIS MODEL 12873SUB 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 | — | $366,047 | Oct 31, 2022 | — – — |
| Subcontractor | Department of Health and Human Services | OPTION 4 ACTIVITIES: CONDUCT TWO PHASE 1 CLINICAL TRIALS IN THE CONTROLLED HUMAN MYCOBACTERIAL CHALLENGE MODEL
TB044: A CLINICAL CHALLENGE STUDY TO EVALUATE CONTROLLED HUMAN INFECTION WITH BCG ADMINISTERED BY THE AEROSOL INHALED ROUTE IN HISTORICALLY BCG-VACCINATED HEALTHY ADULT VOLUNTEERS
TB045: A PHASE I CLINICAL TRIAL TO EVALUATE (I) THE ADAPTIVE IMMUNE RESPONSE TO A CONTROLLED HUMAN INFECTION WITH AEROSOL BCG; AND (II) THE PROTECTIVE EFFICACY OF A PRIOR BCG VACCINATION AND/OR ID93+GLA-SE VACCINATION USING THIS MODEL 12717SUB 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 | — | $89,537 | Mar 31, 2022 | — – — |
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 Health and Human ServicesGov-sourced
- Department of DefenseGov-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.