The International Vaccine Institute (IVI) on Wednesday announced that the first participant received Bharat Biotech's Chikungunya vaccine candidate (BBV87) in a Phase II/III clinical trial in Costa Rica.
This marks the beginning of a multi-country study led by IVI in partnership 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 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.
"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," said Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech International Limited.
"Chikungunya is a severe and devitalizing disease. Taking into cognizance the need to develop an effective vaccine for chikungunya, the Department of Biotechnology, Government of India has provided financial support under the Ind-CEPI Mission, to Bharat Biotech for the Global Chikungunya Vaccine Clinical Development Program (GCCDP). It is very encouraging to witness the commencement of Phase II/III study of BBV87 in Costa Rica. This milestone is a first step towards developing a promising vaccine candidate against Chikungunya, an exhausting disease," said Dr. Renu Swarup, Secretary, Department of Biotechnology (DBT) and Chairperson, Biotechnology Industry Research Assistance Council (BIRAC).
Dr. Sushant Sahastrabuddhe, Acting Associate Director General at IVI and Principal Investigator of GCCDP stated that 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.
The announcement furthers CEPI's US $3.5bn 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 International Limited in June 2020, providing up to US $14.1 million for vaccine manufacturing and clinical development of the BBV87 vaccine candidate. The funding is supported by the European Union's (EU's) Horizon 2020 program through an existing framework partnership agreement with CEPI. The consortium was also supported with a grant of up to US $2.0 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.