COVAXIN™ – Phase 2 Study Results & Phase 1 Follow-up Data

by Bharatbiotech
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COVAXIN™ (BBV152) showed long-term antibody and T-cell memory responses (3-months after vaccination) in phase 1 volunteers, and tolerable safety outcomes with enhanced humoral & cell-mediated immune responses in the Phase 2 study.

SALIENT FEATURES –

  • In a double-blind, randomised, multi-centre, phase 2 clinical trial a total of 380 healthy children and adults were randomised to receive two vaccine formulations (n=190 each) with 3 µg and 6 µg with Algel-IMDG.
  • Two intramuscular doses of vaccines were administered (four weeks apart).
  • In a follow-up of the phase 1 trial, BBV152 produced high levels of neutralising antibodies that remained elevated in all participants three months (at day 104) after the second vaccination. Based on these results, we hypothesize that BBV152 can generate antibodies that may persist for 6-12 months.
  • Higher neutralising titres (2-fold) was observed in the phase 2 study than in the phase 1 study.
  • Both vaccine groups elicited more Th1-biased cytokines than Th2-biased cytokines.
  • After two doses, local and systemic adverse reactions observed in both vaccine groups were minimal, and the majority of them resolved within 24 hours of onset. No serious adverse events were reported in this study.

SUMMARY:

The results from the phase 2 study show that both humoral and cell-mediated responses were observed. No neutralising antibody differences were observed between sexes and across age groups. BBV152 was well tolerated in both dose groups with no serious adverse events.

The paper is available on an online preprint (non-peer-reviewed) server at https://www.medrxiv.org/content/10.1101/2020.12.21.20248643v1.full.pdf 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]

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