Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) for COVID-19 in Healthy Volunteers

Phase 1 study The study is designed to evaluate the safety, reactogenicity, tolerability, and immunogenicity of Four arms of healthy volunteers who receive two intramuscular doses of BBV152 vaccine formulations or Placebo. A total no of 375 subjects will be enrolled in 4:1 ratio. This study will be conducted in a dose escalatory manner with a two-dose regimen fourteen days apart. Phase 2 study The study is designed to evaluate the safety, reactogenicity, tolerability, and immunogenicity of two arms of healthy volunteers who will receive two intramuscular doses of BBV152 vaccine formulations (BBV152-A \& BBV152-B) in a 1:1 ratio with dosage schedule on Day 0 and Day 28. A protocol amendment was made to evaluate a boosting regimen at the 6-month interval in the Phase 2 trial. At 6 months post-dose 2, participants who received the 6ug Algel-IMDG allocation were randomized equally to receive a third dose of BBV152 (6ug Algel-IMDG) or placebo. The investigator, participant and Sponsor were blinded to the allocation.