IVI, Bharat Biotech launch chikungunya vaccine phase II/III trial in Costa Rica
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
Hyderabad: The International Vaccine Institute (IVI) said 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 global 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 randomised, controlled trial to evaluate the safety and immunogenicity of a 2-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.
Bharat Biotech’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.
The Global Chikungunya Vaccine Clinical Development Program (GCCDP) seeks to develop and manufacture 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.
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 authorisation in emergency situations based on national or international guidance.
Dr Krishna Ella, CMD, Bharat Biotech International Limited, said, “Epidemic preparedness is a vital step in public health care. The IVI-led multi-country scale human trial has begun an important trial phase in furthering the evaluation of safety and immunogenicity.”
Dr Renu Swarup, secretary, Department of Biotechnology (DBT) and Chairperson, Biotechnology Industry Research Assistance Council (BIRAC), said, “Chikungunya is a severe and devitalising disease. Taking into cognisance 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.”
Dr Sushant Sahastrabuddhe, acting associate director General at IVI and Principal Investigator of GCCDP, said, “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.”
CEPI first partnered with IVI and Bharat Biotech International Limited in June 2020, providing up to $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.
.
Now you can get handpicked stories from Telangana Today on Telegram everyday. Click the link to subscribe.
Click to follow Telangana Today Facebook page and Twitter .
