INDIA – The International Vaccine Institute (IVI) and Bharat Biotech has announced the beginning of Phase II/III clinical trial of Chikungunya vaccine candidate (BBV87) in Costa Rica.
IVI is leading the Global Chikungunya vaccine Clinical Development Program (GCCDP) consortium 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.
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.
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 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 programme 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, the release added.
IVI said it is advancing clinical development of BBV87 through a Phase II/III randomized, controlled trial to evaluate the safety and immunogenicity of a two-dose regimen of BBV87 Chikungunya vaccine in healthy adults at nine clinical trial sites across five 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 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 worldwide,” said Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech.
Chikungunya virus was first identified in Tanzania in 1952, with sporadic outbreaks of the disease reported subsequently across Africa and Asia.
In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, the total number of cases has been estimated at over 3.4 million in 43 countries.