Bharat Biotech, IVI launch Chikungunya vaccine phase 2/3 trial in Costa Rica

International Vaccine Institute (IVI) and Bharat Biotech on Wednesday announced the launch of Phase II/III clinical trial of Chikungunya vaccine candidate (BBV87) in Costa Rica.

The randomised, controlled trial is 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.

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.

Chikungunya is spread by the bites of infected female Aedes mosquitoes and causes fever, severe joint pain, muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years.

The clinical trial launch marks the beginning of a multi-nation study funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the Ind-CEPI mission of the government of India's Department of Biotechnology.

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.

“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),” Bharat Biotech said in a statement on Wednesday.

“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 to GCCDP’s effort for a safe, efficacious vaccine that can help reduce Chikungunya cases,” said Dr Krishna Ella, CMD, Bharat Biotech International Limited.

CEPI’s US $3.5 billion plan was launched in March 2021 to tackle future epidemics and pandemics, including advancing vaccine candidates against known high-risk pathogens such as Chikungunya.