HYDERABAD: Bharat Biotech’s chikungunya vaccine candidate (BBV87) has commenced a multi-country phase II and III clinical trials with the first participant receiving a jab in Costa Rica. The study is being conducted to evaluate safety and immunogenicity of a two-dose regimen of BBV87 in healthy adults at nine clinical trial sites across five countries with endemic chikungunya.
Bharat Biotech has joined hands with the International Vaccine Institute (IVI), which is leading the Global Chikungunya vaccine Clinical Development Programme (GCCDP), for BBV87. The study is being funded by Coalition for Epidemic Preparedness Innovations (CEPI) with support from Ind-CEPI mission of Department of Biotechnology.
Apart from Clinica San Agustin in Costa Rica, trials will begin in Panama and Colombia by September and in Thailand and Guatemala soon after, Bharat Biotech said. The inactivated whole virion vaccine, based on a strain derived from an East, Central, South African genotype, has completed standard pre-clinical studies, and elicited optimum immune response in phase-I trials in India, the company said.
As part of the tie-up, CEPI or Bharat Biotech may look at third-party manufacturing of stockpiles of investigational product to be used for further clinical trials in outbreak conditions to advance vaccine development, it added.
The global partnership will provide critical data for further clinical development of the vaccine with the hopes of meeting CEPI’s goal to develop, license and gain WHO Prequalification for a Chikungunya vaccine and make it accessible to affected populations
