INTERNATIONAL VACCINE INSTITUTEPub 78
Pub 78
Programs
Clinical Trial Research Program
THE PHASE II COMPONENT OF THE STUDY IS COMPLETED, AND THE INTERIM CLINICAL STUDY REPORT (CSR) FROM PHASE II (PARTS A AND B) IS AVAILABLE. BASED ON ADDITIONAL TESTING RESULTS OF DAYS 28 AND 56 OF PHASE 2 SUBGROUP SAMPLES, DATA FROM NHP PASSIVE TRANSFER STUDY, AND SAFETY DATA, A FINAL DECISION ON THE OPTIMAL DOSE FOR PART C WAS MADE, AND 40 UG WAS SELECTED. A CONSORTIUM CONSENSUS JUSTIFICATION MEMO OF FINAL DOSE SELECTION IS COMPLETED. PROTOCOL AMENDMENT V 5.0 CONTAINING THIS NEW INFORMATION WAS APPROVED BY LOCAL ECS AND NRAS. VIRTUAL PI MEETINGS WITH ALL SITES TO UPDATE PROGRAM STATUS AND PROJECTION OF PART C START DATE WERE PERFORMED. A NEW VERSION OF THE INVESTIGATOR BROCHURE (IB) WAS RELEASED IN FEBRUARY 2024. AN AD HOC DSMB MEETING THAT AIMED TO REVIEW IN MORE DETAIL THE PREGNANCIES CASES THAT OCCURRED IN THE PHASE 2 CLINICAL TRIAL IN FEBRUARY 2024. NO SAFETY CONCERNS WERE FOUND IN THE REPORTED DATA. THE START OF ENROLMENT FOR PART C IS NOW PLANNED IN Q3 2025 DUE TO CHANGES IN THE IP MANUFACTURING PROCESS (FROM CELL STACKS TO BIOREACTORS) AND SPONSORSHIP CHANGES FROM IVI TO BHARAT GCCDP 2 CLINICAL TRIAL PROTOCOL SUMMARIES (INCLUDING CHILDREN AND IMMUNOSUPPRESSED POPULATION) WERE PRESENTED TO CEPI DURING THE BID DEFENSE MEETING HELD IN LONDON IN FEBRUARY 2024GeographiesNot indicatedDatesJan 1, 2024 – Dec 31, 2024Source990No causes providedNo populations provided–$2.4MBPCOV2 Project
BPCOV2 PROJECT - 2024 SUMMARY OF ACTIVITIES (REFERENCE YEAR 2024) IN 2024, THE BPCOV2 PROJECT ADVANCED PRE-CLINICAL DEVELOPMENT OF A NEXT-GENERATION PAN-CORONAVIRUS MRNA VACCINE PLATFORM SUPPORTED BY CEPI. PROJECT PARTNERS (UPENN, UNC, UC DAVIS, CHULA VRC, AND IVI) FOCUSED ON MRNA CONSTRUCT DESIGN AND PRODUCTION. MULTIPLE MRNA CONSTRUCTS WERE PRODUCED AND TESTED, INCLUDING SPIKE VARIANTS, CHIMERIC CONSTRUCTS, AND VLP PLATFORMS, FORMULATED WITH SM-102 TO ENABLE PLATFORM COMPARISON.GeographiesNot indicatedDatesJan 1, 2024 – Dec 31, 2024Source990No causes providedNo populations provided–$1.7MVAT0008 Clinical Trial
VAT0008 IS A PIVOTAL MULTI-COUNTRY PHASE 3, MULTI-STAGE, MODIFIED DOUBLE-BLIND AND MULTI-ARM STUDY WHERE EFFICACY, SAFETY AND IMMUNOGENICITY OF TWO SARS-COV-2 ADJUVANTED RECOMBINANT PROTEIN VACCINES (MONOVALENT AND BIVALENT) WERE TESTED AS PRIMARY SERIES AND MONOVALENT BOOSTER DOSE AS AN EXTENSION. IVI LED THE EFFORT IN NEPAL TO CONDUCT THE CLINICAL TRIAL INCLUDING CONDUCTING THE LOCAL DSMB MEETING. THE PRIMARY SERIES STUDY WAS INITIATED IN JULY 2021. THE FIRST SUBJECT FOR THE PRIMARY SERIES WAS ENROLLED IN SEPTEMBER 2021. THE CROSSOVER/BOOSTER PHASE STARTED IN JANUARY 2023. THE LAST SUBJECT VACCINATION FOR THE CROSSOVER/BOOSTER PHASE WAS COMPLETED IN NOVEMBER 2023. INVESTIGATORS MEETING WAS CONDUCTED IN FEBRUARY 2023 FOR THE SUCCESSFUL CONDUCTION OF THE PRIMARY SERIES STUDY. THE 11TH DSMB MEETING WAS HELD ON SEPTEMBER 2023, AND NO SAFETY CONCERN WAS RAISED. IVI TEAM CONDUCTED A QUALITY CONTROL VISIT IN Q3 2023. FINAL QUALITY CONTROL VISIT TO SITES WAS DONE IN Q2 2024. STUDY SITE CLOSE-OUT WAS ACTIVITY WAS COMPLETED IN Q3 2024. STUDY DOCUMENT ARCHIVING PROCESS WAS DONE IN Q3 2024. FINAL DATABASE LOCK WAS DONE IN Q3 2024. FINAL DSMB PREPARATION WAS COMPLETED AT THE END OF 2024, AND MEETING WAS CONDUCTED IN JANUARY 2025. NO SAFETY CONCERNS WERE RAISED.GeographiesNot indicatedDatesJan 1, 2024 – Dec 31, 2024Source990No causes providedNo populations provided–$1.5M
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