To report preliminary results on the efficacy and safety of Gam-COVID-Vac from the interim analysis of this phase 3 trial.
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https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00234-8/fulltext |
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February 02, 2021 |
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Randomised controlled phase 3 trial |
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Moscow, Russia |
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Level I : RCT |
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To report preliminary results on the efficacy and safety of Gam-COVID-Vac from the interim analysis of this phase 3 trial. |
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The researchers in this study present the preliminary clinical efficacy results of the rAd26 and rAd5 vector-based COVID-19 vaccine Gam-COVID-Vac in a randomised, double-blind, placebo-controlled multicentre phase 3 trial in Moscow, Russia, with 21 862 participants. They present the trial’s initial immunogenicity findings, which include receptor-binding domain-specific IgG titers, virus neutralising antibody titers, and IFN- response. |
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The phase 3 trial of Gam-COVID-Vac showed efficacy 91·6% against COVID-19 and was well tolerated in a large cohort, according to the interim analysis. |
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The interim analysis of the randomised, controlled, phase 3 trial of Gam-COVID Vac in Russia revealed high efficacy, immunogenicity, and a good tolerability profile in participants aged 18 years of age or older |
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Gam-COVID-Vac (Sputnik V), a heterologous recombinant adenovirus (rAd)-based vaccine, demonstrated good safety and induced strong humoral and cellular immune responses in participants in phase 1/2 clinical trials. The researchers present preliminary findings from the interim analysis of this phase 3 trial on the efficacy and safety of Gam-COVID-Vac. |