Hyderabad: International Vaccine Institute (IVI) on Wednesday said Bharat Biotech's Chikungunya vaccine candidate (BBV87) was administered to first volunteer in Costa Rica during phase II/III clinical trial.
This marks a multi-country study led by IVI in partnership with Bharat Biotech and funded by the Coalition for Epidemic Preparedness Innovations (CEPI). It is being supported by the Ind-CEPI mission of the Department of Biotechnology.
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.
BBIL'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. Inactivated virions technology has a safety profile that potentially makes this vaccine accessible to special populations, such as the immunocompromised and pregnant women, that some other technologies cannot reach.
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 the 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).
"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 the world over," said Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech International Limited.
Dr. Renu Swarup, Secretary, Department of Biotechnology (DBT) and Chairperson, Biotechnology Industry Research Assistance Council (BIRAC said the Centre 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," Dr. Renu said