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IVI, Bharat Bio start phase-2 trial of chikungunya vaccine
IVI, Bharat Bio start phase-2 trial of chikungunya vaccine
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
Hyderabad: IN partnership with Bharat Biotech, International Vaccine Institute (IVI) initiated phase II, III clinical trial of chikungunya vaccine. A participant in Costa Rica received the first jab on Wednesday.
The trials are 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 trial to evaluate the safety and immunogenicity of a 2-dose regimen of chikungunya vaccine in healthy adults at nine clinical trial sites across five countries with the endemic.
After the trial at Clinica San Agustin in Costa Rica, trials are expected to begin in Panama and Colombia by September 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.
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).
