COVAXIN™ – Phase 1 Study Results

by Bharatbiotech
0 comment 11130 views

COVAXIN™ (BBV152) demonstrated acceptable safety profile and high immune response, which induced T-cell responses in Phase 1 study.


  • In a Phase 1 placebo-controlled, double-blinded clinical trial, an inactivated SARS-CoV-2 vaccine (BBV152) was evaluated in 375 subjects.
  • On day 28 (14 days after 2nd dose), all subjects who received the vaccine intramuscularly had significantly elevated Spike binding IgG antibodies and Neutralizing Antibody titers.
  • The vaccine induced antibody responses reported, were able to neutralize both homologous (vaccine virus strain) and heterologous (divergent) SARS-CoV-2 strains.
  • A Th1 biased T-cell response was observed.
  • Local reactions and systemic events after immunization were generally mild in nature and resolved transiently. No serious (grade 3-4) adverse events were reported.


BBV152 induced binding and neutralizing antibody responses & with the inclusion of the Algel-IMDG adjuvant, this is the first inactivated SARS-CoV-2 vaccine that has been reported to induce a Th1-biased response. Phase 2 trials are in analysis and phase 3 clinical trials are underway.

The paper is available on an online preprint (non-peer reviewed) server at and is concurrently undergoing scientific peer-review for potential publication.

*Disclaimer: The provided study information is a preprint publish and has not yet undergone peer review. The findings are provisional and the conclusions/final results may differ.

Forward Looking Statement: [Download PDF]

You may also like

Leave a Comment