The International Vaccine Institute 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 2-dose regimen of BBV87 Chikungunya vaccine in healthy adults at 9 clinical trial sites across 5 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 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).
Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, said: “Epidemic preparedness is a vital step in public health care. Bharat Biotech’s vaccine candidate is an ingenious, well-researched vaccine, and we thank the first volunteer from Costa Rica for participating in this study. The IVI-led multi-country scale human trial has begun an important trial phase in furthering the evaluation of safety and immunogenicity. As a partner, we are committed towards GCCDP’s effort to realize a safe, efficacious vaccine that can help reduce Chikungunya disease burden world over.”
“As a leader in pandemic vaccines, we have demonstrated unwavering commitment in solving the Chikungunya, Pandemic Flu, Zika and Typhoid problems, as well as our relentless dedication to solve public health challenges through research and development of novel vaccines.”
Dr. Ella added, “Our Director of R&D, Dr. Sumathy K, Head of the Chikungunya vaccine development program, is actively involved with research and development of this vaccine and works closely with the GCCDP consortium.”
Dr. Sushant Sahastrabuddhe, Acting Associate Director General at IVI and Principal Investigator of GCCDP, said: “We are thrilled to announce that the first participant was dosed with BBIL’s Chikungunya vaccine candidate in a multi-country Phase II/III study. The start of this trial in Costa Rica is a significant milestone in the effort to make available a safe, effective, and affordable Chikungunya vaccine for the one billion people around the world at risk of Chikungunya virus infection. We are grateful to our partner Bharat Biotech, our clinical trial site collaborators and partners, and CEPI for this collective effort that will generate crucial safety and immunogenicity data in regions most affected by Chikungunya.”