Product Development Award (Bridging Award)
Vaccines
2024
11 / 27 / 2024
11 / 30 / 2027
36
Phase 2
Cholera
Sub-Saharan Africa
IVI (International Vaccine Institute) / Republic of Korea
EuBiologics / Republic of Korea, Massachusetts General Hospital / USA
3,999,909,800
🔗Novel Cholera Conjugate Vaccine (BA 1)
Building on the successful Phase I clinical trial funded by RIGHT Foundation that confirmed safety and promising immunogenicity of the Cholera Conjugate Vaccine (CCV), the International Vaccine Institute(IVI) has secured a Bridging Award to advance to Phase II studies. This next phase will produce clinical
trial materials and conduct studies in endemic populations, focusing on determining optimal dosing, formulation (with or without adjuvant), and schedules for adults and children through an age-descending approach. By leveraging polysaccharide conjugation technology, CCV aims to deliver higher efficacy, longer-lasting protection, and potential integration into routine childhood immunization programs (EPI). The Phase II trials will specifically evaluate single versus two-dose regimens and explore prime-boost combinations with OCV in children under five. This breakthrough vaccine could significantly reduce cholera burden globally by offering a more effective, programmatically suitable alternative to current interventions, potentially transforming cholera control strategies worldwide.