SEATTLE CHILDREN'S HOSPITAL

Subcontracted by this company · 13 sub-awards · latest Nov 4, 2026

• “THE GERNER LAB WILL DEFINE THE SPATIAL ORGANIZATION AND FUNCTIONAL STATE OF MYCOBACTERIUM TUBERCULOSIS (MTB) AND OF THE HOST IMMUNE RESPONSE WITHIN INFECTED TISSUES, AS WELL AS CONTRIBUTE TO THE ONGOING SPATIAL TRANSCRIPTOMIC ANALYSIS WORK OF EARLY MTB CONTROL. THE GERNER LAB WILL APPLY MULTIPLEX ANTIBODY-BASED IMAGING OF THE MTB PROTEOME, TOGETHER WITH ESTABLISHED IMMUNE CELL AND STRUCTURAL MARKER PANELS, IN WELL-CHARACTERIZED MOUSE INFECTION MODELS AND WITH FURTHER TESTING IN HUMAN TB TISSUES, AND WILL ADVANCE THE SPATIAL TRANSCRIPTOMIC STUDY OF EARLY LUNG LESION DEVELOPMENT. THIS WORK SUPPORTS THE CENTRAL GOALS OF THE CASCADE CONTRACT AND CONTRIBUTES IMAGING AND SPATIAL TRANSCRIPTOMIC DATASETS TO THE CENTER’S CROSS-SPECIES INTEGRATION AND COMPUTATIONAL MODELING ACTIVITIES. A. MOUSE IMMUNOLOGIC STUDIES – MTB PROTEOME IMAGING ACTIVITY 1 (MONTHS 1-12): VALIDATE ANTIBODY-BASED PROBES FOR DETECTION OF THE MTB PROTEOME AND MTB FUNCTIONAL STATES IN WELL-CHARACTERIZED MOUSE INFECTION SAMPLES. SUB-ACTIVITY 1: VALIDATE AND BENCHMARK THE MTB-SPECIFIC ANTIBODY ARRAYS AVAILABLE THROUGH BEI RESOURCES AND THE FORTUNE/GRACE LABS (HI-IMPAC-TB) IN MOUSE TISSUES CONTAINING IDENTIFIABLE MTB BACILLI (MCHERRY) AND DEFINED FUNCTIONAL STATES (LIVE/DEAD, HSPX’), WITH ESTABLISHED IMMUNE AND STRUCTURAL MARKERS. A. SCREEN THE ANTIBODY ARRAYS USING ARCHIVED SAMPLES, INCLUDING DAY 35 LIVE/DEAD LUNGS FROM B6/H37RV AND C3H/SA161, AND DAY 15 AND DAY 30 HSPX’ LUNGS AND DRAINING LYMPH NODES FROM B6/H37RV INFECTION. B. PERFORM QUANTITATIVE IMAGE ANALYSIS TO DEFINE THE RELATIONSHIP AMONG LOCAL MTB PROTEIN EXPRESSION, BACILLARY BURDEN, BACTERIAL FUNCTIONAL STATE, AND THE SURROUNDING CELLULAR MICROENVIRONMENT. SUB-ACTIVITY 2: DISSECT CHANGES IN MTB PROTEIN EXPRESSION IN SETTINGS OF COMTB OR BCG VACCINATION. A. APPLY PROBES VALIDATED IN SUB-ACTIVITY 1 TO MCHERRY REPORTER STRAIN INFECTIONS IN VACCINATED B6 AND/OR C3H MICE USING AVAILABLE SAMPLE SETS. B. RELATE VACCINE-INDUCED PROTEOME CHANGES TO LESION”
• “THE UNIVERSITY OF WASHINGTON CRYO-EM GROUP (UW-CRYOEM), UNDER THE DIRECTION OF DAVID VEESLER, PH.D., WILL PERFORM THE FOLLOWING WORK TO SUPPORT THE BASIC PROJECT REQUIREMENT. UW-CRYOEM WILL BE RESPONSIBLE FOR SOLVING CRYOEM STRUCTURES DURING THIS CONTRACT YEAR (SEPT 1, 2026 THROUGH AUG 31, 2027). UW-CRYOEM WILL ALSO MANAGE (SHEPHERD) A PANDEMIC PREPAREDNESS PROJECT AND WILL SUPPORT OTHER SPECIAL STUDIES AS NEEDED. A. STRUCTURE DETERMINATION OF PROTEINS OR PROTEIN COMPLEXES BY CRYOEM: UW-CRYOEM (DR. VEESLER) WILL DETERMINE THE STRUCTURE OF PROTEIN OR PROTEIN COMPLEXES USING CRYOEM AS A PART OF THIS SUBCONTRACT. THESE TARGET(S) WILL ORIGINATE FROM NIAID CATEGORY A-C INFECTIOUS DISEASE ORGANISMS, AS WELL AS EMERGING AND RE-EMERGING DISEASE AND ONCE APPROVED BY NIAID WILL ENTER THE SSGCID PIPELINE FOR TRACKING THE UW-CRYOEM WORK. THE TARGETS SELECTED WILL BE IMPACTFUL AND MAY BE MANAGED AS HIGH VALUE TARGET (HVT), COMMUNITY REQUEST PROJECT (CRP), HIGHEST IMPACT PROJECT (HIP) AND OTHER SPECIAL STUDIES WITHIN THE SSGCID PIPELINE. PROTEINS FROM VIRAL AND/OR EUKARYOTIC TARGETS WILL BE EXPRESSED IN BACULOVIRUS-INFECTED INSECT CELLS OR MAMMALIAN CELLS (HEK), WHILE BACTERIAL TARGETS (IF SELECTED FOR CRYOEM) WILL BE EXPRESSED IN E. COLI. THE MOLECULAR WEIGHT AND STOICHIOMETRY OF THE PURIFIED PROTEINS WILL BE CONFIRMED USING ANALYTICAL SEC COUPLED WITH MULTI-ANGLE LIGHT SCATTERING (SEC-MALS). THE HOMOGENEITY AND STRUCTURAL STABILITY OF THE PURIFIED PROTEINS WILL ALSO BE ASSESSED BY HIGH-THROUGHPUT NEGATIVE STAIN ELECTRON MICROSCOPY USING AN AUTOMATED DATA COLLECTION AND PROCESSING PIPELINE. PROMISING SAMPLES WILL BE FURTHER EVALUATED BY COMPUTING LOW-RESOLUTION THREE-DIMENSIONAL RECONSTRUCTIONS THAT DEMONSTRATE THE COMPOSITIONAL AND CONFORMATIONAL HETEROGENEITY OF EACH SAMPLE. THIS INFORMATION CAN ALSO BE USED TO GUIDE FURTHER CONSTRUCT SELECTION AND OPTIMIZATION OF THE EXPRESSION AND PURIFICATION CONDITIONS (IF NECESSARY). SAMPLES WILL BE VITRIFIED WITH AN FEI VITROBOT DE”
• “THE UNIVERSITY OF WASHINGTON NMR GROUP (UW-NMR), UNDER THE DIRECTION OF GABRIELE VARANI, PH.D., WILL PERFORM THE FOLLOWING WORK TO SUPPORT THE BASIC PROJECT REQUIREMENT. UW-NMR WILL BE RESPONSIBLE FOR SOLVING 1 NMR STRUCTURE DURING THIS ONE YEAR SUBCONTRACT PERIOD, 9/1/2026 – 8/31/2027) AND FOR LEADING ONE PROJECT ON PANDEMIC PREPAREDNESS AND RAPID RESPONSE TO OUTBREAKS/EPIDEMIC/PANDEMICS. A. STRUCTURE DETERMINATION OF PROTEINS OR RNA MOLECULE BY NMR: UW-NMR WILL DETERMINE THE SOLUTION STRUCTURE OF PROTEINS OR RNA MOLECULES USING NUCLEAR MAGNETIC RESONANCE (NMR)-BASED METHODS. THESE TARGETS WILL ORIGINATE FROM NIAID CATEGORY A-C INFECTIOUS DISEASE ORGANISMS, AS WELL AS EMERGING AND RE-EMERGING DISEASES AND ONCE APPROVED BY NIAID WILL ENTER INTO THE SSGCID PIPELINE FOR TRACKING THE UW-NMR WORK. THE NMR SPECTROSCOPY WILL BE MAINLY DEDICATED TO PROTEINS SMALLER THAN ~25 KDA THAT FAIL TO PRODUCE DIFFRACTION QUALITY CRYSTALS. THE CANDIDATE TARGETS WILL PRIMARILY BE IDENTIFIED FROM COMMUNITY REQUESTS AND INTERNAL BATCHES; SPECIFICALLY, THESE WILL BE TARGETS OF INTEREST TO THE CENTER THAT COULD NOT BE DETERMINED USING CRYSTALLOGRAPHY. HOWEVER, DR. VARANI WILL ALSO IDENTIFY RELEVANT COLLABORATORS HIMSELF WHO ARE WILLING TO NOMINATE TARGETS TO THE NMR PIPELINE AND ARE WILLING TO COLLABORATE TO PUBLISH ANY RESULTS PRODUCED BY SSGCID, ESPECIALLY IN THE AREA OF BACTERIAL AND VIRAL NON CODING RNAS. UW-NMR MAY ALSO BE ASKED TO LEAD AND SUPPORT HIGH VALUE TARGET (HVT), COMMUNITY REQUEST PROJECT (CRP), HIGHEST IMPACT PROJECT (HIP) AND OTHER SPECIAL STUDIES WITHIN THE SSGCID PIPELINE, AS DECIDED BY THE SSGCID SCIENTIFIC LEADERSHIP TEAM, WHENEVER OPPORTUNITIES ARISE FOR ADVANCING SCIENTIFIC PROBLEMS THAT MIGHT BEST BE ADDRESSED BY NMR. CANDIDATES SUITABLE FOR FURTHER EXAMINATION WILL BE IDENTIFIED FROM 1H-15N HSQC SPECTRA COLLECTED ON 15N-LABELED PROTEIN PREPARED BY UW-NMR. STANDARD TRIPLE RESONANCE EXPERIMENTS WILL BE PERFORMED TO ASSIGN THE BACKBONE AND THE SIDE CHAIN RESONANC”

Subcontracted by this company · 4 sub-awards · latest Jan 12, 2026

• “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”
• “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”
• “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-S”

Subcontracted by this company · 4 sub-awards · latest Oct 8, 2025

• “THIS STATEMENT OF WORK (SOW) OUTLINES THE ACTIVITIES THAT UK HEALTH SECURITY AGENCY (UKHSA), PREVIOUSLY KNOWN AS PUBLIC HEALTH ENGLAND (PHE), 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-DERIVED SAMPLES AND/OR DOWNSTREAM DATA MAY BE SHARED WITH THE PARTNERS ON THIS CONTRACT. OPTION 2 ACTIVITIES: OBJECTIVE: EVALUATE OPTIMIZED M.TB VACCINE CANDIDATES FOR SAFETY, IMMUNOGENICITY AND EFFICACY IN GUINEA PIG MODEL OF TB TASK 2.1 EVALUATE IMMUNE RESPONSE OF TB CANDIDATE VACCINES IN GUINEA PIGS GUINEA PIG IMMUNOLOGY THE ABILITY TO STUDY IMMUNE RESPONSES IN GUINEA PIGS IS SLOWLY IMPROVING. METHODOLOGY FOR DETERMINING A VARIETY OF CELL- SURFACE MARKERS, CYTOKINES AND CHEMOKINES HAS BEEN DEVELOPED AND STUDIES HAVE BEEN PERFORMED ON BCG-VACCINATED AND M.TB-INFECTED GUINEA PIGS. RELATED SOPS DEVELOPED AT PARTNER INSTITUTES LIKE CSU WILL BE SHARED WITH UKHSA FOR PERFORMANCE OF GUINEA PIG ENDPOINTS AND ASSAY HARMONIZATION. THE NUMBER OF ANTIBODY REAGENTS REMAINS RESTRICTIVE BUT SOME KEY FEATURES OF THE IMMUNE RESPONSE HAVE BEEN DESCRIBED. USING FLOW CYTOMETRY, IT IS POSSIBLE TO MONITOR CD4 AND CD8 T CELLS IN THE LUNGS AND STAINING WITH CD62L PLUS GATING VERSUS CD45 CAN IDENTIFY ACTIVATED T CELLS. FURTHER DEVELOPMENT OF ANTIBODI”
• “THIS STATEMENT OF WORK (SOW) OUTLINES THE ACTIVITIES THAT UK HEALTH SECURITY AGENCY (UKHSA), PREVIOUSLY KNOWN AS PUBLIC HEALTH ENGLAND (PHE), 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.M72 ACTIVITIES: THE ANIMALS USED IN THESE STUDIES WILL BE RHESUS MACAQUES OF INDIAN GENOTYPE OBTAINED FROM ESTABLISHED UK BREEDING COLONIES AND WILL BE BETWEEN 3 AND 6 YEARS OF AGE (TYPICALLY BETWEEN 4 – 12 KG). ABSENCE OF PREVIOUS EXPOSURE TO MYCOBACTERIAL ANTIGENS AND/OR NTM RECOGNITION WILL BE CONFIRMED BY EX VIVO IFN-Γ ELISPOT TO MEASURE RESPONSES TO PURIFIED PROTEIN DERIVATIVE (PPD) FROM M.TB, POOLED 15-MER PEPTIDES OF ESAT-6 AND CFP-10 AND NTM MEGA PEPTIDE POOLS FOR SCREENING TIMEPOINTS AND MTB300 FOR POST VACCINATION AND M.TB CHALLENGE TIMEPOINTS AS AVAILABLE. THE PROJECT LICENSE ENABLING THESE STUDIES WILL BE APPROVED BY THE ANIMAL WELFARE AND ETHICAL REVIEW BODY AT UKHSA PORTON AND GRANTED BY THE HOME OFFICE, UK. ANIMALS WILL BE HOUSED IN SOCIALLY COMPATIBLE GROUPS AND ACCORDING TO THE CODE OF PRACTICE FOR THE HOUSING AND CARE OF ANIMALS BRED, SUPPLIED OR USED FOR SCIENTIFIC PURPOSES, DECEMBER 2014, THE NC3RS, AND THE GUIDELINES ON”
• “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).”

Subcontracted by this company · 3 sub-awards · latest Sep 15, 2026

• “THE UNIVERSITY OF KANSAS (KU), UNDER THE DIRECTION OF SCOTT LOVELL, PH.D., WILL PERFORM THE FOLLOWING WORK TO SUPPORT THE BASIC PROJECT REQUIREMENT (9/1/2026-8/31/2027). KU WILL ACCEPT PROTEIN AND OTHER SAMPLES PRIMARILY GENERATED BY OTHER SSGCID SITES AND PREPARE THEM FOR X-RAY CRYSTALLOGRAPHY STRUCTURE DETERMINATION STUDIES, CONDUCT CRYSTALLIZATION EXPERIMENTS, COLLECT DIFFRACTION DATA, AND PERFORM STRUCTURE SOLUTION. KU WILL ALSO SUPPORT VARIOUS SPECIAL PROJECT STUDIES AS NEEDED AND LEAD ONE FUNCTIONAL STUDY. A. STRUCTURE DETERMINATION OF PROTEINS OR PROTEIN COMPLEXES BY X-RAY CRYSTALLOGRAPHY: KU WILL ACCEPT PROTEIN SAMPLES PRIMARILY RECEIVED FROM THE OTHER TEAM SITES FOR X-RAY CRYSTALLOGRAPHY STRUCTURE DETERMINATION STUDIES AND CONDUCT HIGH THROUGHPUT CRYSTALLIZATION EXPERIMENTS, INCLUDING CRYSTALLIZATION TRIALS, OPTIMIZATION, DATA COLLECTION AND INTERPRETATION. WHEN NECESSARY, KU WILL CONDUCT CO-CRYSTALLIZATION SCREENS OF THE TARGET IN COMPLEX WITH SMALL MOLECULES AND LIGANDS. KU WILL IDENTIFY AND HARVEST CRYSTALS THAT ARE SUITABLE FOR DIFFRACTION SCREENING AND CONDUCT LARGE SCALE CRYSTAL DIFFRACTION SCREENS, COLLECT DIFFRACTION DATA AND MONITOR QUALITY METRICS OF THE SUITABLE CRYSTALS. WHERE APPROPRIATE, KU WILL ALSO LIAISE WITH KUMC’S CRYOEM CENTER TO HELP SOLVE STRUCTURES BY CRYOEM. KU WILL PERFORM STRUCTURE SOLUTION, MODEL REFINEMENT AND VALIDATION FOR X-RAY CRYSTALLOGRAPHY. A STRUCTURE DETERMINATION PROJECT WILL BE CONSIDERED COMPLETE WHEN THE REFINEMENT AND VALIDATION OF THE FINAL STRUCTURE MODELS DO NOT PROVIDE ANY CLEAR SIGNAL OF WHERE THE MODEL CAN BE IMPROVED OR WHEN 3D STRUCTURE QUALITY PARAMETERS SATISFY THE MINIMUM QUALITY REQUIREMENTS ESTABLISHED AND AGREED UPON IN COORDINATION WITH THE CENTER FOR STRUCTURAL BIOLOGY OF INFECTIOUS DISEASES. KU WILL SUPPORT HIGH VALUE TARGETS (HVTS), COMMUNITY REQUEST PROJECTS (CRP), HIGHEST IMPACT PROJECTS (HIP) AND OTHER SPECIAL STUDIES WITHIN THE SSGCID PIPELINE, AS DECIDED BY THE SSGCID SCIENTIFIC L”
• “THE UNIVERSITY OF KANSAS (KU), UNDER THE DIRECTION OF SCOTT LOVELL, PH.D., WILL PERFORM THE FOLLOWING WORK TO SUPPORT THE BASIC PROJECT REQUIREMENT (9/1/2025-8/31/2026). KU WILL ACCEPT PROTEIN AND OTHER SAMPLES PRIMARILY GENERATED BY OTHER SSGCID SITES AND PREPARE THEM FOR X-RAY CRYSTALLOGRAPHY STRUCTURE DETERMINATION STUDIES, CONDUCT CRYSTALLIZATION EXPERIMENTS, COLLECT DIFFRACTION DATA, AND PERFORM STRUCTURE SOLUTION. KU WILL ALSO SUPPORT VARIOUS SPECIAL PROJECT STUDIES AS NEEDED AND LEAD ONE FUNCTIONAL STUDY. STRUCTURE DETERMINATION OF PROTEINS OR PROTEIN COMPLEXES BY X-RAY CRYSTALLOGRAPHY: KU WILL ACCEPT PROTEIN SAMPLES PRIMARILY RECEIVED FROM THE OTHER TEAM SITES FOR X-RAY CRYSTALLOGRAPHY STRUCTURE DETERMINATION STUDIES AND CONDUCT HIGH THROUGHPUT CRYSTALLIZATION EXPERIMENTS, INCLUDING CRYSTALLIZATION TRIALS, OPTIMIZATION, DATA COLLECTION AND INTERPRETATION. WHEN NECESSARY, KU WILL CONDUCT CO-CRYSTALLIZATION SCREENS OF THE TARGET IN COMPLEX WITH SMALL MOLECULES AND LIGANDS. KU WILL IDENTIFY AND HARVEST CRYSTALS THAT ARE SUITABLE FOR DIFFRACTION SCREENING AND CONDUCT LARGE SCALE CRYSTAL DIFFRACTION SCREENS, COLLECT DIFFRACTION DATA AND MONITOR QUALITY METRICS OF THE SUITABLE CRYSTALS. WHERE APPROPRIATE, KU WILL ALSO LIAISE WITH KUMC’S CRYOEM CENTER TO HELP SOLVE STRUCTURES BY CRYOEM. KU WILL PERFORM STRUCTURE SOLUTION, MODEL REFINEMENT AND VALIDATION FOR X-RAY CRYSTALLOGRAPHY. A STRUCTURE DETERMINATION PROJECT WILL BE CONSIDERED COMPLETE WHEN THE REFINEMENT AND VALIDATION OF THE FINAL STRUCTURE MODELS DO NOT PROVIDE ANY CLEAR SIGNAL OF WHERE THE MODEL CAN BE IMPROVED OR WHEN 3D STRUCTURE QUALITY PARAMETERS SATISFY THE MINIMUM QUALITY REQUIREMENTS ESTABLISHED AND AGREED UPON IN COORDINATION WITH THE CENTER FOR STRUCTURAL BIOLOGY OF INFECTIOUS DISEASES. KU WILL SUPPORT HIGH VALUE TARGETS (HVTS), COMMUNITY REQUEST PROJECTS (CRP), HIGHEST IMPACT PROJECTS (HIP) AND OTHER SPECIAL STUDIES WITHIN THE SSGCID PIPELINE, AS DECIDED BY THE SSGCID SCIENTIFIC LEADERSHIP”
• “THE UNIVERSITY OF KANSAS (KU), UNDER THE DIRECTION OF SCOTT LOVELL, PH.D., WILL PERFORM THE FOLLOWING WORK TO SUPPORT THE BASIC PROJECT REQUIREMENT (9/1/2024-8/31/2025). KU WILL ACCEPT PROTEIN AND OTHER SAMPLES PRIMARILY GENERATED BY OTHER SSGCID SITES AND PREPARE THEM FOR X-RAY CRYSTALLOGRAPHY STRUCTURE DETERMINATION STUDIES, CONDUCT CRYSTALLIZATION EXPERIMENTS, COLLECT DIFFRACTION DATA, AND PERFORM STRUCTURE SOLUTION. KU WILL ALSO SUPPORT VARIOUS SPECIAL PROJECT STUDIES AS NEEDED AND LEAD ONE FUNCTIONAL STUDY. A. STRUCTURE DETERMINATION OF PROTEINS OR PROTEIN COMPLEXES BY X-RAY CRYSTALLOGRAPHY: KU WILL ACCEPT PROTEIN SAMPLES PRIMARILY RECEIVED FROM THE OTHER TEAM SITES FOR X-RAY CRYSTALLOGRAPHY STRUCTURE DETERMINATION STUDIES AND CONDUCT HIGH THROUGHPUT CRYSTALLIZATION EXPERIMENTS, INCLUDING CRYSTALLIZATION TRIALS, OPTIMIZATION, DATA COLLECTION AND INTERPRETATION. WHEN NECESSARY, KU WILL CONDUCT CO-CRYSTALLIZATION SCREENS OF THE TARGET IN COMPLEX WITH SMALL MOLECULES AND LIGANDS. KU WILL IDENTIFY AND HARVEST CRYSTALS THAT ARE SUITABLE FOR DIFFRACTION SCREENING AND CONDUCT LARGE SCALE CRYSTAL DIFFRACTION SCREENS, COLLECT DIFFRACTION DATA AND MONITOR QUALITY METRICS OF THE SUITABLE CRYSTALS. WHERE APPROPRIATE, KU WILL ALSO LIAISE WITH KUMC€„¢S CRYOEM CENTER TO HELP SOLVE STRUCTURES BY CRYOEM. KU WILL PERFORM STRUCTURE SOLUTION, MODEL REFINEMENT AND VALIDATION FOR X-RAY CRYSTALLOGRAPHY. A STRUCTURE DETERMINATION PROJECT WILL BE CONSIDERED COMPLETE WHEN THE REFINEMENT AND VALIDATION OF THE FINAL STRUCTURE MODELS DO NOT PROVIDE ANY CLEAR SIGNAL OF WHERE THE MODEL CAN BE IMPROVED OR WHEN 3D STRUCTURE QUALITY PARAMETERS SATISFY THE MINIMUM QUALITY REQUIREMENTS ESTABLISHED AND AGREED UPON IN COORDINATION WITH THE CENTER FOR STRUCTURAL BIOLOGY OF INFECTIOUS DISEASES. KU WILL SUPPORT HIGH VALUE TARGETS (HVTS), COMMUNITY REQUEST PROJECTS (CRP), HIGHEST IMPACT PROJECTS (HIP) AND OTHER SPECIAL STUDIES WITHIN THE SSGCID PIPELINE, AS DECIDED BY THE SSGC”

Subcontracted by this company · 3 sub-awards · latest Nov 19, 2025

• “STATEMENT OF WORK – YEAR 7 (BASE) THE DU PLESSIS/WALZL LABORATORY AT STELLENBOSCH UNIVERSITY (SU) WILL BE RESPONSIBLE FOR THE CLINICAL AND IMMUNOLOGICAL WORK (INCLUDING ON-SITE DATA MANAGEMENT) OF THE PROJECT. SU WILL COORDINATE THE STUDY DESIGN, PARTICIPANT SCREENING AND ENROLLMENT FOR THE CASCADE HOUSEHOLD CONTACT STUDY, PERFORM BRONCHOSCOPIES AND MANAGE SAMPLE SHARING TO PARTICIPATING SITES. SU WILL PROVIDE INPUT IN THE DESIGN, EXECUTION AND DATA ANALYSIS OF IMMUNOLOGICAL STUDIES AND PARTICIPATE IN THE LEADERSHIP TEAM OF “CASCADE IMPAC-TB” CENTER. SU WILL INTERACT AND COORDINATE ALL PROJECT ACTIVITIES WITH THE PI OF THE PROJECT. DR. DU PLESSIS AND DR. WALZL, THE SU CO-PI’S WILL REVIEW ALL RAW DATA GENERATED BY THE SU TEAM, AND SUPERVISE THE LABORATORY WORK, AND THE RESEARCH TECHNICIANS. SPECIFIC DELIVERABLES FOR YEAR 7 OF THE CONTRACT AT SU INCLUDE THE FOLLOWING: A. RECRUITMENT: SU WILL CONDUCT PET/CT, BRONCHOSCOPY AND PHLEBOTOMY IN ALL COHORTS TO COVER THE FULL SPECTRUM OF INFECTION AND OBTAIN BAL AND PBMC SAMPLES FROM EACH. RECRUITMENT HAS BEEN COMPLETED, AND NO NEW PARTICIPANTS ARE BEING ENROLLED. HOWEVER, WE ARE FOLLOWING UP SELECTED PARTICIPANTS TO SCREEN FOR TB PROGRESSION WITH LONGITUDINAL SAMPLING, REQUIRING ETHICS APPROVAL AND LIMITED CONTINUED CLINICAL INVOLVEMENT. B. END-ASSAYS: IMMUNOPHENOTYPING EXPERIMENTS – ONE OF THE DELIVERABLES AT SU IS TO CONDUCT DEEP PHENOTYPING OF PAIRED BRONCHOALVEOLAR LAVAGE (BAL) AND PBMC FROM THE VARIOUS CASCADE HOUSEHOLD CONTACT STUDY CLINICAL GROUPS. SU HAS EVALUATED THE ASSAY PRIORITY LIST, AS WELL AS THE BAL AND PBMC SAMPLES COLLECTED FROM PARTICIPANTS ENROLLED IN THE CASCADE HOUSEHOLD CONTACT STUDY, TO ENUMERATE THE NUMBER OF STORED SAMPLES AVAILABLE FOR THE OBJECTIVES RELATED TO THE PROPOSED PLANS FOR THIS END-ASSAY. OF ALL MAIN STUDY PARTICIPANTS FROM WHICH PAIRED BAL AND PBMC HAVE BEEN COLLECTED, SUFFICIENT CELL NUMBERS WERE OBTAINED FROM 88% OF PARTICIPANTS, WHICH INCLUDES MAKING USE OF RESIDUALLY STORED BAL”
• “THE DU PLESSIS/WALZL LABORATORY AT STELLENBOSCH UNIVERSITY (SU) WILL BE RESPONSIBLE FOR THE CLINICAL AND IMMUNOLOGICAL WORK (INCLUDING ON-SITE DATA MANAGEMENT) OF THE PROJECT. SU WILL COORDINATE THE STUDY DESIGN, PARTICIPANT SCREENING AND ENROLLMENT FOR THE CASCADE HOUSEHOLD CONTACT STUDY, PERFORM BRONCHOSCOPIES AND MANAGE SAMPLE SHARING TO PARTICIPATING SITES. SU WILL PROVIDE INPUT IN THE DESIGN, EXECUTION AND DATA ANALYSIS OF IMMUNOLOGICAL STUDIES AND PARTICIPATE IN THE LEADERSHIP TEAM OF €œCASCADE IMPAC-TB€Ͽ½ CENTER. SU WILL INTERACT AND COORDINATE ALL PROJECT ACTIVITIES WITH THE PI OF THE PROJECT. DR. DU PLESSIS AND DR. WALZL, THE SU CO-PI€„¢S WILL REVIEW ALL RAW DATA GENERATED BY THE SU TEAM, AND SUPERVISE THE LABORATORY WORK, AND THE RESEARCH TECHNICIANS. SPECIFIC DELIVERABLES FOR YEAR 6 OF THE CONTRACT AT SU INCLUDE THE FOLLOWING: A. RECRUITMENT: THE ANTICIPATED SCREENING AND RECRUITMENT GOALS HAVE BEEN ACHIEVED AND EXCEEDED. WHILE THE INITIAL RECRUITMENT TARGET WAS SET AT 20 PARTICIPANTS FOR EACH OF THE 8 CLINICAL GROUPS (N=160 TOTAL), WE EXCEEDED THIS TO ACHIEVE AND ENROLL A TOTAL NUMBER OF 185 STUDY PARTICIPANTS ACROSS ALL GROUPS FOR THE MAIN STUDY. THE COVID-19 PANDEMIC HAS RESULTED IN A REQUEST FOR A SOMEWHAT ALTERED CLASSIFICATION AND ENROLLMENT TARGET OF CLINICAL GROUPS, WHICH WAS APPROVED BY THE NIH IN 2021. THE SU HHC STUDY NOW CONSISTS OF GROUPS STRATIFIED NOT ONLY BY IGRA RESULTS OR PET/CT READOUT, BUT ALSO BY SARS-COV-2 SEROLOGY STATUS. THE BUDGET FOR PERIOD 6 WILL INCLUDE LIMITED PARTICIPANT RECRUITMENT AND BRONCHOSCOPIES, AS ORIGINALLY PROPOSED, WHICH WILL INCLUDE ONLY STUDY PARTICIPANTS FROM SELECTED €œBIOLOGICALLY INTERESTING€Ͽ½ CLINICAL PHENOTYPES FOR FURTHER TARGETED FUNCTIONAL ANALYSES THROUGH GRANULOMA MODEL MANIPULATION. SU HAS BUDGETED FOR N=12 BRONCHOSCOPIES. B. END-ASSAYS: IMMUNOPHENOTYPING EXPERIMENTS €€Œ ONE OF THE DELIVERABLES AT SU IS TO CONDUCT DEEP PHENOTYPING OF PAIRED BRONCHOALVEOLAR LAVAGE”
• “THE WALZL LABORATORY AT STELLENBOSCH UNIVERSITY (SU) WILL BE RESPONSIBLE FOR THE CLINICAL AND IMMUNOLOGICAL WORK (INCLUDING ON SITE DATA MANAGEMENT) OF THE PROJECT. SU WILL COORDINATE SAMPLE SHARING FROM EXISTING SAMPLE COLLECTIONS SUCH AS THE GC6 STUDY COLLECTION. SU WILL PROVIDE INPUT IN STUDY DESIGN OF IMMUNOLOGICAL STUDIES AND PARTICIPATE IN THE LEADERSHIP TEAM OF €œCASCADE IMPAC-TB€Ͽ½ CENTER, AND WILL ALSO PERFORM SOME OF THE BRONCHOSCOPIES. SU WILL INTERACT AND COORDINATE ALL PROJECT ACTIVITIES WITH THE PI OF THE PROJECT. TOGETHER WITH DR. DU PLESSIS, THE SU CO-PI, DR. WALZL, WILL REVIEW ALL RAW DATA GENERATED BY THE SU TEAM, AND SUPERVISE THE LABORATORY WORK, AND THE RESEARCH TECHNICIAN. SPECIFIC DELIVERABLES FOR YEAR 4 OF THE CONTRACT AT SU INCLUDE THE FOLLOWING: A. RECRUITMENT MAIN STUDY: THE ORIGINAL RECRUITMENT GOALS WERE 50 STUDY PARTICIPANTS FOR PERIOD 1, 51 STUDY PARTICIPANTS FOR PERIOD 2, 57 STUDY PARTICIPANTS FOR PERIOD 3, 23 STUDY PARTICIPANTS FOR PERIOD 4, 18 STUDY PARTICIPANTS FOR PERIOD 5, 17 STUDY PARTICIPANTS FOR PERIOD 6 AND 20 STUDY PARTICIPANTS FOR PERIOD 7, TO MEET THE TOTAL OF 236 STUDY PARTICIPANTS FOR THE MAIN CONTRACT. DUE TO COVID-19, THE START OF RECRUITMENT WAS DELAYED BY ABOUT EIGHT MONTHS AND THE PACE OF RECRUITMENT HAS BEEN SLOW DUE TO MULTIPLE COVID-19 RELATED RESTRICTIONS AND CHALLENGES. TO ACCOUNT FOR THIS, WE NOW ARE INCLUDING AN ADDITIONAL N=30 STUDY PARTICIPANTS WHO ARE COVID-19 POSITIVE INTO THE MAIN CONTRACT, BRINGING THE TOTAL STUDY PARTICIPANTS TO N=266 FOR THE MAIN STUDY. THE NATIONAL STATE OF DISASTER, DUE TO THE COVID-19 PANDEMIC, WAS LIFTED ON APRIL 5, 2022, IN SOUTH AFRICA AND, AS OF JUNE 23, 2022, RESTRICTIONS THAT LIMITED THE CAPACITY WERE LIFTED. SU NO LONGER HAS TO LIMIT THE STAFF ON SITE. RESUMING CASCADE ACTIVITIES HAS THEREFORE INCREASED. FOR THE CASCADE MAIN STUDY, WE HAVE COMPLETED THE PERIOD 1 AND PERIOD 2 RECRUITMENT GOAL OF 101 PARTICIPANTS ALONG WITH THE PROCESSING OF BIOLOGICAL SPECIMENS”

Subcontracted by this company · 2 sub-awards · latest Nov 18, 2025

• “STATEMENT OF WORK – YEAR 7 (BASE) – GALE THE GALE LABORATORY WILL PERFORM RNA-SEQ ASSAYS FOR THE NHP IMMUNOLOGIC STUDIES IN YEAR 7. WHOLE BLOOD AND TISSUE SAMPLES WILL BE RECEIVED AT THE GALE LABORATORY AT THE UNIVERSITY OF MINNESOTA FROM LOUIS PICKER (OHSU). RNA-SEQ ASSAYS WILL BE CONDUCTED BY UNIVERSITY OF MINNESOTA GENOME CENTER (UMGC). RNA-SEQ ASSAY TASKS INCLUDE 1) RNA ISOLATION AND RNA QC, 2) RNA-SEQ LIBRARY CONSTRUCTION AND LIBRARY QC, AND 3) GENERATION OF RNA SEQUENCE DATA FROM THE RESULTING MRNA-SEQ LIBRARIES ON A UG 100 PLATFORM. THE GALE LABORATORY WILL CONDUCT COMPUTATIONAL DATA ANALYSIS AND MODELING ON THE RNA-SEQ DATA SETS. IN YEAR 7, THE GALE LAB WILL ANALYZE NHP WHOLE BLOOD AND TISSUE RNA-SEQ DATA SETS THAT WERE GENERATED IN YEAR 7 AND PRIOR PERIODS. THIS ANALYSIS WILL INCLUDE BUT NOT BE LIMITED TO INITIAL DATA QC, GENERATION OF NORMALIZED EXPRESSION MATRICES, DIFFERENTIAL GENE EXPRESSION ANALYSIS, FUNCTIONAL ANALYSIS, CO-EXPRESSION ANALYSIS AND WHEN APPROPRIATE RULE-BASED MODELING.”
• “THE OVERALL GOAL OF THE IMPAC-TB PROGRAM IS TO INFORM THE RATIONAL DESIGN OF AN EFFECTIVE TB VACCINE BY IDENTIFICATION OF IMMUNE RESPONSES THAT ARE CAPABLE OF CONTROLLING AND POTENTIALLY EVEN ERADICATING MTB. WE WILL ACHIEVE THIS GOAL BY IDENTIFYING AND DISSECTING PROTECTIVE PATHWAYS IN NATURAL AND VACCINE-INDUCED IMMUNITY THROUGH INTEGRATED ANALYSES OF TISSUE-SPECIFIC AND SYSTEMIC IMMUNITY IN MICE, NON-HUMAN PRIMATES (NHP), AND HUMANS. 1. THE GALE LABORATORY WILL CONDUCT RNA-SEQ ASSAYS FOR THE NHP IMMUNOLOGIC STUDIES. IN YEAR 6, THE GALE LABORATORY WILL PERFORM RNA-SEQ ASSAYS ON NHP SAMPLES COLLECTED FROM EXP #1, EXP #2, AND EXP #4. TASKS INCLUDE 1) RECEIVING TISSUE HOMOGENATE SAMPLES RECEIVED AT THE UNIVERSITY OF MINNESOTA FROM LOUIS PICKER (OHSU), 2) ISOLATING RNA FROM THESE SAMPLES AND PERFORMING RNA QC, 3) CONSTRUCTING RNA-SEQ LIBRARIES AND LIBRARY QC USING THE ISOLATED RNA, AND 4) GENERATING RNA SEQUENCE DATA FROM THE RESULTING MRNA-SEQ LIBRARIES. 2. THE GALE LABORATORY WILL CONDUCT COMPUTATIONAL DATA ANALYSIS AND MODELING ON THE RNA-SEQ DATA SETS. IN YEAR 6, THE GALE LAB WILL ANALYZE NHP WHOLE BLOOD RNA-SEQ DATA SETS THAT WERE GENERATED AT UNIVERSITY OF WASHINGTON (GALE LAB) DURING YEAR 5. THIS ANALYSIS WILL INCLUDE BUT NOT BE LIMITED TO INITIAL DATA QC, GENERATION OF NORMALIZED EXPRESSION MATRICES, DIFFERENTIAL GENE EXPRESSION ANALYSIS, FUNCTIONAL ANALYSIS, CO-EXPRESSION ANALYSIS AND WHEN APPROPRIATE RULE-BASED MODELING.”

Subcontracted by this company · 3 sub-awards · latest Nov 14, 2025

• “IN YEAR 7, THE EDLEFSEN GROUP AT FRED HUTCHINSON CANCER CENTER (FRED HUTCH) WILL PROVIDE DATA QUALITY ASSURANCE PROCESSES AND ENSURE THE TIMELINESS AND ACCURACY OF STATISTICAL ANALYSES AND THE EFFECTIVE COMMUNICATION OF RESULTS. FRED HUTCH WILL DEVELOP REPRODUCIBLE RESEARCH ANALYSIS SOFTWARE AND NOVEL ANALYTICAL METHODS. IN ADDITION, FRED HUTCH WILL CONTRIBUTE TO THE DESIGN AND PROPER STATISTICAL CONDUCT OF ALL AIMS, AND ASSOCIATED DATA. DR. EDLEFSEN WILL COLLABORATE WITH AN INDEPENDENT CONTRACTOR BASED IN GDANSK, POLAND, TO PROVIDE BIOINFORMATICS EXPERTISE ON THE PROJECT. FRED HUTCH IS CONDUCTING THESE ACTIVITIES ON AN ONGOING BASIS AND CONDUCTING ACTIVITIES MEETING THESE DESCRIPTIONS IN ALL YEARS OF THE CONTRACT.”
• “THIS STATEMENT OF WORK (SOW) OUTLINES THE ACTIVITIES THAT FRED HUTCHINSON CANCER CENTER (FHCC EDLEFSEN) WILL BE PERFORMING. NOTE THAT THE TASK NUMBERS BELOW REFLECT THE NUMBERING OF THE OVERALL ACTIVITIES IN THE PRIME CONTRACT. ALTHOUGH THIS SOW DETAILS THE COMPLETE SUITE OF PROPOSED WORK, THE TASKS ASSOCIATED WITH THIS CONTRACT ITERATION ARE LIMITED TO THE SPECIFIC ACTIVITIES OUTLINED BELOW, DELIVERABLES FOR THIS CONTRACT PERIOD ARE HIGHLIGHTED. YEAR 6 (BASE) €€Œ EDLEFSEN IN YEAR 6, THE EDLEFSEN GROUP AT FRED HUTCHINSON CANCER CENTER (FRED HUTCH) WILL PROVIDE DATA QUALITY ASSURANCE PROCESSES AND ENSURE THE TIMELINESS AND ACCURACY OF STATISTICAL ANALYSES AND THE EFFECTIVE COMMUNICATION OF RESULTS. FRED HUTCH WILL DEVELOP REPRODUCIBLE RESEARCH ANALYSIS SOFTWARE AND NOVEL ANALYTICAL METHODS. IN ADDITION, FRED HUTCH WILL CONTRIBUTE TO THE DESIGN AND PROPER STATISTICAL CONDUCT OF ALL AIMS, AND ASSOCIATED DATA. DR. EDLEFSEN WILL COLLABORATE WITH AN INDEPENDENT CONTRACTOR BASED IN GDANSK, POLAND, TO PROVIDE BIOINFORMATICS EXPERTISE ON THE PROJECT. FRED HUTCH IS CONDUCTING THESE ACTIVITIES ON AN ONGOING BASIS AND CONDUCTING ACTIVITIES MEETING THESE DESCRIPTIONS IN ALL YEARS OF THE CONTRACT.”
• “THIS STATEMENT OF WORK (SOW) OUTLINES THE ACTIVITIES THAT FRED HUTCHINSON CANCER CENTER (FHCC) WILL BE PERFORMING. NOTE THAT THE TASK NUMBERS BELOW REFLECT THE NUMBERING OF THE OVERALL ACTIVITIES IN THE PRIME CONTRACT. ALTHOUGH THIS SOW DETAILS THE COMPLETE SUITE OF PROPOSED WORK, THE TASKS ASSOCIATED WITH THIS CONTRACT ITERATION ARE LIMITED TO THE SPECIFIC ACTIVITIES OUTLINED BELOW, DELIVERABLES FOR THIS CONTRACT PERIOD ARE HIGHLIGHTED. 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 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 3.5 TRANSCRIPTOMIC ANALYSIS OF NHP SAMPLES. FHCC WILL EXECUTE GENE EXPRESSION PROFILING WITH RNASEQ/NANOSTRING ASSAYS ON NHP SAMPLES GENERATED IN OPTION 3 AT UKHSA. TRANSCRIPTOMIC ANALYSIS WILL BE FOCUSED ON IDENTIFYING A PERIPHERAL BLOOD SURROGATE ENDPOINT FOR THE M.TB ERDMAN ULDA CHALLENGE OUTCOMES. THE INITIAL UNBIASED RNA SEQUENCING APPROACH WILL USE WHOLE-BLOOD SAMPLES FROM PRE- AND POST-CHALLENGE TIME POINTS. SPECIFICALLY, WE WILL LOOK FOR TRANSCRIPTS THAT ARE CORRELATED WITH M.TB COLONY FORMING UNITS (CFU) AND M.TB QPCR ASSAYS FROM BRONCHOALVEOLAR LAVAGE (BAL), THE PRIMARY CHALLENGE OUTCOMES. IN ADDITION TO ABSOLUTE ABUNDANCE AT PO”

Subcontracted by this company · 1 sub-award · latest Sep 2, 2025

• “AFRICA HEALTH RESEARCH INSTITUTE (AHRI) WILL CONDUCT GLOBAL MOLECULAR MEASUREMENTS ON TB CASES AND CONTROLS IN THE VUKUZAZI COHORT TO DEFINE CORRELATES OF PROTECTION AND TEST HYPOTHESIZED MECHANISMS OF PROTECTION ARISING FROM WITHIN THE CENTER OR OTHER PROGRAMS (YEARS 2-7). IN YEAR 4, AHRI WILL SPECIFICALLY: ACTIVITY 1: IDENTIFY EARLY TB CASES AND MTB-INFECTED UNDISEASED CONTROLS FROM PARTICIPANTS IN THE VUKUZAZI COHORT. ACTIVITY 2: IDENTIFY LATE TB CASES AND MTB-INFECTED UNDISEASED CONTROLS FROM PARTICIPANTS IN THE VUKUZAZI COHORT. ACTIVITY 3: CONDUCT TRANSCRIPTIONAL ANALYSIS ON WHOLE-BLOOD FROM TB CASES AND MATCHED CONTROLS IN THE VUKUZAZI STUDY. €ƒ”

Subcontracted by this company · 2 sub-awards · latest Nov 25, 2025

• “STATEMENT OF WORK – YEAR 7 (BASE) – BAROUCH LAB DURING THE PRECEDING YEARS OF THE AWARD, WE FOCUSED ON DEVELOPING AN INNOVATIVE AND PHYSIOLOGICALLY RELEVANT MOUSE CHALLENGE MODEL THAT UNDERGOES REPEATED ULTRA-LOW DOSE MTB EXPOSURES TO ASSESS THE PROTECTIVE EFFICACY OF TB VACCINES. IN YEAR 6, WE SUCCESSFULLY ESTABLISHED AND VALIDATED A HIGHLY REPRODUCIBLE MURINE REPEATED ULTRA-LOW DOSE CHALLENGE MODEL WITH REDUCED STRINGENCY. USING THIS MODEL, WE TESTED THE PROTECTIVE EFFICACY OF BCGS AND ΔLPRG VACCINES. UNDER THE REPEATED ULTRA-LOW DOSE EXPOSURE MODEL, ΔLPRG IMMUNIZATION CONFERRED ~65% PROTECTION AGAINST ACQUISITION OF INFECTION, COMPARED WITH ~45% PROTECTION OBSERVED WITH THE SINGLE ULTRA-LOW DOSE CHALLENGE, REPRESENTING A SIGNIFICANT IMPROVEMENT IN VACCINE-INDUCED PROTECTION. WE ALSO EXPANDED OUR CORRELATES OF PROTECTION ANALYSES TO IDENTIFY CELLULAR AND MOLECULAR FACTORS ASSOCIATED WITH PROTECTION FROM THE ACQUISITION OF INFECTION. A MANUSCRIPT DESCRIBING THESE FINDINGS IS CURRENTLY IN PREPARATION. IN YEAR 7, BASED ON THE DATA COLLECTED DURING THE PRECEDING YEAR, OUR RESEARCH WILL FOCUS ON EXTENDING CORRELATES OF PROTECTION STUDIES AND CONDUCTING MECHANISTIC ANALYSES TO DEFINE THE CELLULAR SUBSETS AND PATHWAYS UNDERLYING VACCINE-MEDIATED PROTECTION. WE WILL FURTHER CHARACTERIZE INFECTION KINETICS AND IMMUNE RESPONSES TO REPEATED ULTRA-LOW DOSE MTB EXPOSURE MODEL TO BETTER UNDERSTAND HOW LOW-LEVEL MTB EXPOSURE SHAPES HOST IMMUNITY AND SUBSEQUENT INFECTION OUTCOMES. TO PERFORM THESE STUDIES, WE WILL UTILIZE A BARCODED MTB STRAIN TO MONITOR INFECTION DYNAMICS UNDER REPEATED ULTRA-LOW DOSE AEROSOL CHALLENGES. FINALLY, WE WILL ALSO APPLY THIS PHYSIOLOGICALLY RELEVANT CHALLENGE MODEL TO EVALUATE THE PROTECTIVE EFFICACY OF EMERGING TB VACCINES, INCLUDING SUBUNIT MRNA, PROTEIN-BASED, AND LIVE-ATTENUATED VACCINES.”
• “THIS STATEMENT OF WORK (SOW) OUTLINES THE ACTIVITIES THAT UNIVERSITY OF BETH ISRAEL DEACONESS MEDICAL CENTER (BIDMC) WILL BE PERFORMING. NOTE THAT THE TASK NUMBERS BELOW REFLECT THE NUMBERING OF THE OVERALL ACTIVITIES IN THE PRIME CONTRACT. ALTHOUGH THIS SOW DETAILS THE COMPLETE SUITE OF PROPOSED WORK, THE TASKS ASSOCIATED WITH THIS CONTRACT ITERATION ARE LIMITED TO THE SPECIFIC ACTIVITIES OUTLINED BELOW, DELIVERABLES FOR THIS CONTRACT PERIOD ARE HIGHLIGHTED. YEAR 6 €€Œ BAROUCH OUR RESEARCH PROJECTS IN THE PRECEDING YEARS OF THE AWARD FOCUSED ON DEVELOPING INNOVATIVE MURINE AEROSOL CHALLENGE MODELS FOR THE EVALUATION OF TUBERCULOSIS VACCINES. A RECENT PUBLICATION ESTABLISHED SUBSTANTIAL VACCINE PROTECTION WITH THE LIVE-ATTENUATED ΀�LPRG VACCINE STRAIN IN THE ULTRA LOW-DOSE MURINE AEROSOL CHALLENGE MODEL AS WELL AS THE DEVELOPMENT OF A NOVEL REPEATED ULTRA LOW- DOSE CHALLENGE MODEL THAT LED TO THE IDENTIFICATION OF CORRELATES OF VACCINE PROTECTION. WE OBSERVED THAT THE NOVEL REPEATED ULTRA LOW-DOSE CHALLENGE MODEL RESULTED IN INCREASED STRINGENCY AND REDUCED VACCINE EFFICACY IN TERMS OF PROTECTION FROM DETECTABLE INFECTION AND UNILATERAL INFECTION. IN YEAR 5 WE ESTABLISHED A SECOND-GENERATION MODEL IN WHICH WE FURTHER REDUCED THE CHALLENGE INOCULUM IN ORDER TO PRESERVE A MODEL OF REPEATED EXPOSURE WHILE REDUCING THE STRINGENCY OF CHALLENGE AND IMPROVING THE LIKELIHOOD OF RESOLVING VACCINE EFFICACY. RESEARCH EFFORTS IN YEAR 6 WILL FOCUS ON ASSESSING BCG AND ΀�LPRG VACCINE PROTECTION IN THIS SECOND-GENERATION MODEL IN THE CONTEXT OF A COMPREHENSIVE CORRELATES OF PROTECTION ANALYSIS. RESULTS FROM THE CORRELATES OF PROTECTION ANALYSES WILL BE HYPOTHESIS-GENERATING AND FORM THE BASIS FOR MECHANISTIC STUDIES EVALUATING THE CELLULAR SUBSETS AND PATHWAYS REGULATING VACCINE PROTECTION. THESE STUDIES WILL CONTINUE TO ESTABLISH NEXT-GENERATION MURINE MODELS FOR TB VACCINE TESTING, IDENTIFICATION OF CORRELATES OF PROTECTION, AND MECHANISTIC STUDIES.”

Subcontracted by this company · 1 sub-award · latest Sep 10, 2025

• “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). 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. NON-HUMAN PRIMATE (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 SCRI HAS WORKED WITH DR. RYAN MCNAMARA, WHO HAS PREVIOUSLY BEEN EMPLOYED AT THE RAGON INSTITUTE, TO DEVELOP A WORKPLAN FOR THE SYSTEM SEROLOGY ENDPOINTS FOR BOTH CLINICAL AND PRECLINICAL EVALUATIONS. WE HAVE CONFIRMED THAT A LIST OF 207 M.TB ANTIGENS THAT WERE RECENTLY PUBLISHED ARE NOT PROPRIETARY TO RAGON AND ARE AN APPROPRIATE SET FOR OUR INVESTIGATIONS. TASK 3.7 COMPARE IMMUNE PROFILES IN NHP, SMALL ANIMAL MODELS AND HUMANS TO IDENTIFY CORRELATES OF PROTECTION. SUBTASK 3.7.1 EVALUATE HUMORAL IMMUNITY AS A VACCINE-INDUCED CORRELATE OF PROTECTION USING SYSTEMS SEROLOGY IN THE NHP MODEL. SEVERAL EFFECTOR FUNCTIONS BASED ON THE FC PORTION OF THE ANTIBODY CAN CONTRIBUTE TO THE CLEARANCE OF ORGANISMS, INCLUDING COMPLEMENT ACTIVITY, ANTIBODY-DEPENDENT CELLULAR PHAGOCYTOSIS (ADCP), ANTIBODY-DEPENDENT CELLULAR CYTOTOXICITY (ADCC), ANTIBODY-DEPENDENT CYTOKINE AND CHEMOKINE SECRETION. SYSTEMS SEROLOGY ANALYSIS WILL BE USED TO EVALUATE ANTIBODY EFFECTOR FUNCTIONS INCLUDING NK CELL ACTIVATION, ADCP, AND ADCC. THESE ASSAYS CAPTURE OVER 100 BIOPHYSICAL AND FUNCTIONAL CHARACTERISTICS OF POLYCLONAL ABS, INC”

Subcontracted by this company · 1 sub-award · latest Dec 31, 2023

• “THE SCOPE OF THIS SUBAWARD IS TO ISOLATE CELLS FROM THE TISSUES OF DECEASED PATIENTS AND THEN EXAMINE CELL SUBSET AND FUNCTION WITHIN THE TISSUES OF ACTIVE TB, LATENT TB AND UNINFECTED INDIVIDUALS. SPECIFICALLY IN THIS YEAR OF THE STUDY (YEAR 5) WE WILL RECRUIT AN ADDITIONAL 60 POST-MORTEM SUBJECTS AND CATEGORIZE THEIR TB DISEASE STATE. €¢ WE WILL UNDERTAKE IMMUNOLOGY STUDIES TO EXAMINE CELL SUBSET AND FUNCTION IN THE TISSUES OF DECEASED ACTIVE TB, LATENT TB AND UNINFECTED PATIENTS. €¢ WE WILL CONTINUE DEFINE THE GRANULOMA ANATOMY IN THE DIFFERENT DISEASE STATES; SHIPPING TISSUE SAMPLES TO SCRI/UW IN SEATTLE TO STUDY HETEROGENEITY OF THE IMMUNE LANDSCAPE IN GRANULOMAS AND TISSUES USING MULTIPARAMETER CONFOCAL IMAGING AND SPATIAL GENOMICS. €¢ WE WILL FURTHER INTERROGATE DIFFERENCES WITHIN IDENTIFIED SUBCLINICAL TB SUBJECTS, EXAMINING PHENOTYPE AND FUNCTION OF THE CD4+/KLRG1+/CD27- T CELL SUBSET. FINALLY WE WILL ALSO UNDERTAKE CD45 INTRAVITAL STAINING, ESTABLISHING THE STAINING PROCEDURE AND DETERMINING IF THE CD4+/KLRG1+/CD27- T CELL SUBSET IS EMBEDDED WITHIN THE VASCULATURE, OR ARE TISSUE-RESIDENT”

Subcontracted by this company · 1 sub-award · latest Jan 31, 2024

• “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 (M.TB). OPTION 3 ACTIVITIES: EVALUATE OPTIMIZED M.TB VACCINE CANDIDATES FOR SAFETY, IMMUNOGENICITY AND EFFICACY IN THE NHP MODEL OF TB SCRI HAS WORKED WITH DR. RYAN MCNAMARA AT THE RAGON INSTITUTE TO DEVELOP A WORKPLAN FOR THE SYSTEM SEROLOGY ENDPOINTS FOR BOTH CLINICAL AND PRECLINICAL EVALUATIONS. WE HAVE CONFIRMED THAT A LIST OF 207 M.TB ANTIGENS THAT WERE RECENTLY PUBLISHED ARE NOT PROPRIETARY TO RAGON AND ARE AN APPROPRIATE SET FOR OUR INVESTIGATIONS. TASK 3.7 COMPARE IMMUNE PROFILES IN NHP, SMALL ANIMAL MODELS AND HUMANS TO IDENTIFY CORRELATES OF PROTECTION. SUBTASK 3.7.1 EVALUATE HUMORAL IMMUNITY AS A VACCINE-INDUCED CORRELATE OF PROTECTION USING SYSTEMS SEROLOGY IN THE NHP MODEL. SEVERAL EFFECTOR FUNCTIONS BASED ON THE FC PORTION OF THE ANTIBODY CAN CONTRIBUTE TO THE CLEARANCE OF ORGANISMS, INCLUDING COMPLEMENT ACTIVITY, ANTIBODY-DEPENDENT CELLULAR PHAGOCYTOSIS (ADCP), ANTIBODY-DEPENDENT CELLULAR CYTOTOXICITY (ADCC), ANTIBODY-DEPENDENT CYTOKINE AND CHEMOKINE SECRETION. SYSTEMS SEROLOGY ANALYSIS WILL BE USED TO EVALUATE ANTIBODY EFFECTOR FUNCTIONS INCLUDING NK CELL ACTIVATION, ADCP, AND ADCC. THESE ASSAYS CAPTURE OVER 100 BIOPHYSICAL AND FUNCTIONAL CHARACTERISTICS OF POLYCLONAL ABS, INCLUDING CYTOLYTIC ACTIVITY, PHAGOCYTIC TARGET CLEARANCE, CYTOKINE SECRETION, AND IMMUNOMODULATOR RELEASE. THIS SUITE OF FUNCTIONAL ASSAYS WILL BE UTILIZED TO BROADLY DEFINE THE FC PROFILES OF ID93- AND BCG-SPECIFIC ABS. FOR ALL FUNCTIONAL ASSAYS, THE FUNCTIONAL ACTIVITY OF ABS WILL BE ASSESSED AGAINST ID93, PPD, INFLUENZA HEMAG”

Subcontracted by this company · 1 sub-award · latest Sep 22, 2025

• “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:”

Subcontracted by this company · 1 sub-award · latest Jul 14, 2025

• “THIS STATEMENT OF WORK (SOW) OUTLINES THE ACTIVITIES THAT UNIVERSITY OF ALABAMA AT BIRMINGHAM (UAB) WILL BE PERFORMING. NOTE THAT THE TASK NUMBERS BELOW REFLECT THE NUMBERING OF THE OVERALL ACTIVITIES IN THE PRIME CONTRACT. ALTHOUGH THIS SOW DETAILS THE COMPLETE SUITE OF PROPOSED WORK, THE TASKS ASSOCIATED WITH THIS CONTRACT ITERATION ARE LIMITED TO THE SPECIFIC ACTIVITIES OUTLINED BELOW, DELIVERABLES FOR THIS CONTRACT PERIOD ARE HIGHLIGHTED. UNDER THIS SUBAWARD, DR. WONG (AN ASSISTANT PROFESSOR AT THE UNIVERSITY OF ALABAMA AT BIRMINGHAM), WILL SUPERVISE THE CLINICAL TEAMS IDENTIFYING EARLY AND LATE TB CASES AND CONTROLS FROM PARTICIPANTS IN THE VUKUZAZI COHORT AND COLLECTING SAMPLES FOR ANALYSES. SHE WILL ALSO SUPERVISE AND DIRECT THE TRANSCRIPTOMICS AND COMPUTATIONAL ANALYSES PERFORMED WITH DATA GENERATED BY THESE STUDIES. THESE ANALYSES WILL INCLUDE IDENTIFICATION OF NOVEL CORRELATES OF PROTECTION AND TESTING OF PREDICTED CORRELATES OF PROTECTION ARISING FROM WITHIN THE CENTER OR OTHER PROGRAMS.”