IVI, Bharat Biotech start phase-2 trial of chikungunya vaccine

Hyderabad: IN partnership with Bharat Biotech, International Vaccine Institute (IVI) initiated phase II, III clinical trial of chikungunya vaccine. A participant in Costa Rica received the first jab on Wednesday. The trials are 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 trial to evaluate the safety and immunogenicity of a 2-dose regimen of chikungunya vaccine in healthy adults at nine clinical trial sites across five countries with the endemic. After the trial at Clinica San Agustin in Costa Rica, trials are expected to begin in Panama and Colombia by September 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 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 authorization in emergency situations based on national or international guidance (such as by the WHO).

Dr Krishna Ella, CMD of Bharat Biotech International Ltd, said: "Epidemic preparedness is a vital step in public health care. Our vaccine 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."

The announcement furthers CEPI's $3.5-billion plan, launched in March 2021, to tackle future epidemics and pandemics, which includes advancing vaccine candidates against known high-risk pathogens such as chikungunya. CEPI first partnered with IVI and Bharat Biotech in June 2020, providing up to $14.1 million for vaccine manufacturing and clinical development of the BBV87 vaccine candidate.

The funding is supported by the European Union's Horizon 2020 programme through an existing framework partnership agreement with CEPI. The consortium was also supported with a grant of up to $2 million from the Indian government's Ind-CEPI initiative to fund the set-up of GMP manufacturing facilities for the vaccine in India and subsequent manufacture of clinical trial materials.