COVAXIN™ (BBV152) demonstrated acceptable safety profile and high immune response, which induced T-cell responses in Phase 1 study.
SALIENT FEATURES –
- 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 https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30942-7/fulltext 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.
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