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The International Vaccine Institute (IVI) and Bharat Biotech International Ltd (BBIL) have commenced Phase II/III trials of Global Chikungunya Vaccine in Costa Rica.
“The first participant received Bharat Biotech’s 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 Bharat Biotech,” IVI said in a release on Wednesday.
“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,” Krishna Ella, Chairman and Managing Director of Bharat Biotech International Limited, said.
Also read: Covid-19 vaccination: India administers over 59 crore doses
“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 realise a safe, efficacious vaccine that can help reduce Chikungunya disease burden world over,” he dded.
The study has been 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 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 also expected to begin in Panama and Colombia by September 2021 and in Thailand and Guatemala soon after.
The 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.
Renu Swarup, Secretary, Department of Biotechnology (DBT) and Chairperson, Biotechnology Industry Research Assistance Council (BIRAC) said, “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.”
Also read: Gennova’s mRNA vax gets nod for Phase II, III trials
Today’s 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.
Hyderabad-based Bharat Bio’s BBV87 vaccine is an inactivated whole virion vaccine based on a strain derived from an East, Central, South African (ECSA) genotype. The vaccine has completed standard pre-clinical studies, and an optimum immune response was elicited by the adjuvanted vaccine in phase 1 clinical trials in India.
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.
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