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Lancet Releases Covaxin Phase 2 Trial Data | India News

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HYDERABAD: A week after Bharat Biotech and the Indian Council for Medical Research (ICMR) announced that India’s first indigenous Covid-19 vaccine, Covaxin, (codenamed BBV152) has shown a provisional efficacy of nearly 81 %, the prestigious medical journal The Lancet has published Phase 2 results of clinical trials of the candidate vaccine.
The results of the study entitled ‘Safety and immunogenicity of an inactivated vaccine against SARS-CoV-2, BBV152L are interim results of a phase 2, double-blind, randomized, multicenter and 3-month follow-up trial of a double-blind trial, Randomized Phase 1 Trial ” were published in the British peer-reviewed journal on Tuesday.
“BBV152 led to enhanced immune responses and induced T cell responses that were Th1-biased. Due to the difference in dosing regimens between Phase 1 (two doses given 2 weeks apart) and Phase 2 (two doses given 4 weeks apart) trials, neutralization responses were significantly higher in the trial. phase 2 than in the phase 1 trial, said the research article published in the Lancet.
According to the paper, the proportion of participants who reported adverse events in the phase 2 trial was lower than in the phase 1 trial.
The study also said that no immunological differences were observed between men and women and between age groups, and that both groups that received the vaccine (3 ug with Algel-IMDG and 6 ug with Algel-IMDG) had results of similar security.
Researchers led by ICMR CEO Balram Bhargava and Raches Ella, Project Leader: SARS-CoV-2 Vaccine and Head of Business Development and Promotion, Bharat Biotech, also said that trial tracking data from phase 1 show that BBV152 induces a humoral and cell-mediated immunity three months after the second dose (day 104) of the vaccine.
While the phase 1 study involved 375 volunteers in the 18 to 55 age group at 11 sites, the phase 2 study involved 380 participants in the 12 to 65 age group at nine sites. However, the number of volunteers in the 12-18 and 55-65 age group was lower.
The inactivated whole virion vaccine candidate is currently in phase 3 efficacy trials in 25,800 volunteers at 21 sites across the country.

Times of India

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