The Subject Expert Committee (SEC) on Vaccines, advising India’s top drug regulator, has approved the first human trial of a homegrown chikungunya vaccine developed by Ahmedabad-based Zydus Lifesciences. This inactivated, Vero cell-based formulation is designed to trigger immunity against the mosquito-borne chikungunya virus, for which no approved vaccine is currently available in India.
Job Overview
Zydus Lifesciences has received approval from the DCGI SEC to conduct Phase I human trials for its homegrown chikungunya vaccine candidate. This follows the review of a revised protocol and completed pre-clinical studies. The approval is conditional upon fulfilling substantive requirements before proceeding to larger population trials.
Important Dates
- SEC Meeting Held On: March 19, 2026
Eligibility Criteria
- Healthy volunteers
Age Limit
- Between 18 and 50 years of age
Selection Process
The Phase I study will enroll healthy volunteers who will receive two doses of the vaccine, administered across three cohorts in a cautious step-up design.
Important Instructions
The vaccine is an inactivated, Vero cell-based formulation derived from a parent virus seed (DEN-AFP-SV13-0030).
The trial is registered as BIO/CT/25/000115 with the Central Drugs Standard Control Organisation (CDSCO).
Zydus must report interim data to the CDSCO before moving to Phase II, including immunogenicity results up to 28 days after the second dose, safety data extending to 84 days post-vaccination, and a sign-off report from an independent Data Safety Monitoring Board (DSMB).
Additional conditional requirements before recruiting larger populations include completing a lethal dose challenge test in an animal model or non-human primates, a developmental and reproductive toxicology (DART) study, and generating additional immunogenicity data.
