International Vaccine Institute

TO DISCOVER, DEVELOP AND DELIVER SAFE, EFFECTIVE AND AFFORDABLE VACCINES FOR GLOBAL PUBLIC HEALTH. ITS VISION IS DEVELOPING COUNTRIES FREE OF SUFFERING FROM INFECTIOUS DISEASE.

THE PURPOSE OF GBP510 PHASE III CLINICAL TRIAL IS TO DEMONSTRATE THAT THE IMMUNE RESPONSE INDUCED BY 2 DOSES OF GBP510 AT 4-WEEK INTERVAL IN SERONEGATIVE ADULTS AGED 18 YEARS AND OLDER IS SUPERIOR /NON-INFERIOR TO THE IMMUNE RESPONSE INDUCED BY 2 DOSES OF CHADOX1-S (ASTRAZENECA). IN JANUARY 2022, ALMOST 3500 PARTICIPANTS WERE ENROLLED AT THE 22 STUDY SITES ACROSS 5 COUNTRIES, THAILAND, PHILIPPINES, VIETNAM, NEW ZEALAND AND UKRAINE. THROUGHOUT THE YEAR 2022, 8 PARTICIPANT VISITS WERE COMPLETED INCLUDING 6 BLOOD COLLECTIONS FOR DATA ANALYSIS. FROM Q2 2022, STAGE 2 FOLLOW UP STUDY (IMMUNE RESPONSE OF THIRD DOSE OF GBP510) AT 2 SITES IN THAILAND, STARTED IN PARALLEL WITH THE INITIAL PHASE III STUDY. IN Q3 2022, GBP510, BRAND NAMED SKYCOVIONE HAS BEEN AUTHORIZED BY THE KOREAN MINISTRY OF FOOD AND DRUG SAFETY (KMFDS).

ALL OTHER PROGRAMS

IN THE FIRST HALF OF 2022, THE GCCDP TEAM COMPLETED QUALITY AUDITS FOR THE STUDY SITES IN COSTA RICA AND PANAMA, AND TWO QUALITY CONTROL VISITS WERE PERFORMED BY IVI STUDY TEAM. IN JUNE, THE SECOND DATA AND SAFETY MONITORING BOARD MEETING WAS HELD AND CONCLUDED WITH A "GO" SAFETY DECISION TO INITIATE THE PHASE III COMPONENT OF THE STUDY. FOLLOW-UP MONITORING OF TRIAL PARTICIPANTS IN PHASE II (850 PPL) CONTINUED FOR 12 MONTHS AND COMPLETED BY NOVEMBER. NO SERIOUS UNEXPECTED ADVERSE REACTIONS HAVE BEEN OBSERVED. THE BRITISH NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL, GCCDP'S PARTNER LABORATORY FOR THE NON-HUMAN PRIMATE (NHP) STUDY, COMPLETED THE ACTIVE IMMUNIZATION STUDY AND THE FINAL REPORT IS NOW AVAILABLE. STUDY DATA DEMONSTRATED POTENT PROTECTION WITH BHARAT BIOTECH'S BBV87 CHIKUNGUNYA VACCINE BY BOTH THE IMPACT ON VIRUS REPLICATION AND HOST RESPONSE TO INFECTION. THE INTERIM CLINICAL STUDY REPORT WAS FINALIZED IN JULY 2022, AND UNBLINDED IMMUNOGENICITY RESULTS ARE NOW AVAILABLE. TOGETHER WITH THE NHP STUDY FINDINGS, THESE RESULTS SUPPORTED THE SELECTION OF THE OPTIMAL DOSE FOR THE PHASE III. MEANWHILE, IVI IS WORKING CLOSELY WITH THE PROJECT'S FUNDER, CEPI, AND THE WHO ON VACCINE VALUE PROFILE DEVELOPMENT FOR CHIKUNGUNYA.

IN 2019, IVI BEGAN SIMPLIFYING OCV THROUGH A REFORMULATION OF THE VACCINE TO LOWER THE COST OF PRODUCTION BY 20% WHILE INCREASING PRODUCTION CAPACITY OF EUVICHOL BY 35%. IN OCTOBER 2022, IVI COMPLETED THE CLINICAL TRIAL COMPARING THE LOWER-COST FORMULATION (EUVICHOL-S) TO SHANCHOL. A FINAL STUDY REPORT IS FORTHCOMING IN EARLY 2023.