IVI and Bharat launch global Chikungunya vaccine Phase II/III trial in Costa Rica

The International Vaccine Institute (IVI) has announced the first participant received Bharat Biotech International Ltd’s (BBIL) Chikungunya vaccine candidate (BBV87) in a Phase II/III clinical trial in Costa Rica, marking the start of a multi-country study led by IVI in partnership with BBIL and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the Ind-CEPI mission of the Department of Biotechnology, India.

IVI is advancing clinical development of BBV87 through a Phase II/III randomized, controlled trial to evaluate the safety and immunogenicity of a two-dose regimen of BBV87 Chikungunya vaccine in healthy adults at nine clinical trial sites across five countries with endemic Chikungunya. In addition to the trial at Clinica San Agustin in Costa Rica, trials are expected to begin in Panama and Colombia by September 2021 and in Thailand and Guatemala soon after.

The Global Chikungunya vaccine Clinical Development Program (GCCDP) seeks to develop and manufacture an affordable Chikungunya vaccine with the aim of achieving World Health Organization (WHO) prequalification to enable its distribution in low- and middle-income countries, consistent with CEPI’s core commitment to equitable access, affordability and sustainability. As needed, CEPI or BBIL may propose a third-party for manufacturing of a stockpile of investigational product to be used for further clinical trials in outbreak conditions to advance vaccine development, or pursuant to an emergency use authorization in emergency situations based on national or international guidance (such as by the WHO).