IVI partnership with Bharat Biotech launches Global Chikungunya vaccine Phase II/III trial in Costa Rica
Hyderabad, Aug 25: The International Vaccine Institute (IVI) announced Today the first participant received Bharat Biotech’s Chikungunya vaccine candidate (BBV87) in Phase II/III clinical trial in Costa Rica.
IVI is leading the Global Chikungunya vaccine Clinical Development Program (GCCDP) consortium in partnership with Hyderabad-based Bharat Biotech (BB) and with support from the Coalition for Epidemic Preparedness Innovations (CEPI) and Ind-CEPI mission of the Department of Biotechnology, India.
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, said IVI, a nonprofit inter-governmental organization established at the initiative of the United Nations Development Programme (UNDP), said in a release.
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 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.
CEPI or Bharat Biotech may propose a third party for manufacturing of a stockpile of the investigational products 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). (UNI)