Five countries part of the study to evaluate safety, immunogenicity of BBV87
A multi-country phase II/III clinical trial of Bharat Biotech’s chikungunya vaccine candidate BBV87 by the International Vaccine Institute (IVI) has been rolled out in Costa Rica.
The first participant received BBV87, marking start of a study led by IVI with Bharat Biotech 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 randomised, controlled trial to evaluate safety and immunogenicity of a 2-dose regimen of the chikungunya vaccine candidate in healthy adults at nine clinical trial sites across five countries with endemic chikungunya. The trials are expected to begin in Panama and Colombia by September and subsequently, in Thailand and Guatemala.
IVI and Bharat Biotech in a joint statement said the Global Chikungunya Vaccine Clinical Development Programme (GCCDP) seeks to develop and manufacture an affordable chikungunya vaccine with the aim of achieving WHO prequalification to enable its distribution in low- and middle-income countries. As required, CEPI or Bharat Biotech 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 authorisation based on national or international guidance.
Bharat Biotech CMD Krishna Ella said with the IVI-led multi-country scale human trial has begun an important trial phase. Acting Associate Director General at IVI and Principal Investigator of GCCDP Sushant Sahastrabuddhe said the study will generate crucial safety and immunogenicity data in regions most affected by chikungunya.
Secretary to the department of Biotechnology Renu Swarup said DBT had provided financial support under the Ind-CEPI Mission to Bharat Biotech for the GCCDP. BBV87 is an inactivated whole virion vaccine based on a strain derived from an East, Central, South African (ECSA) genotype, the release said.
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