Express Pharma

Phase I clinical trial outcome shows Covaxin generates antibody, T-cell memory response

A total of 380 healthy children and adults were enrolled for the trial

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Bharat Biotech’s COVID-19 vaccine  Covaxin has shown positive long term antibody and T cell memory response in Phase I clinical trial.

Covaxin (BBV152) has showed long-term antibody and T-cell memory responses three months after the vaccination in phase I clinical volunteers. The published research report it also indicated that the tolerable safety outcomes with enhanced humoral and cell-mediated immune responses in the Phase II study.

As part of the clinical trial double-blind, randomised, multicentre, phase II clinical trial carried out to evaluate the immunogenicity and safety of BBV152. A total of 380 healthy children and adults were randomised to receive two vaccine formulations (n=190 each) with 3 µg with Algel-IMDG and 6 µwith Algel-IMDG.

According to the paper uploaded on ‘medRxiv’,   two intramuscular doses of vaccines were administered (four weeks apart). Paicipants, investigators, and laboratory staff were blinded to the treatment allocation. The primary outcome was seroconversion (≥4-fold above baseline) based on wild-type virus neutralisation (PRNT50). Secondary outcomes were reactogenicity and safety.

In a follow-up of the phase  I 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) wa