publication . Article . 2021

Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia

Denis Y. Logunov; I. V. Dolzhikova; D. V. Shcheblyakov; A. I. Tukhvatulin; O. V. Zubkova; Alina S. Dzharullaeva; Anna V Kovyrshina; Nadezhda L Lubenets; D. M. Grousova; Alina S Erokhova; ...
Open Access English
  • Published: 01 Feb 2021 Journal: The Lancet (issn: 0140-6736, Copyright policy)
  • Publisher: Elsevier BV
Background A heterologous recombinant adenovirus (rAd)-based vaccine, Gam-COVID-Vac (Sputnik V), showed a good safety profile and induced strong humoral and cellular immune responses in participants in phase 1/2 clinical trials. Here, we report preliminary results on the efficacy and safety of Gam-COVID-Vac from the interim analysis of this phase 3 trial. Methods We did a randomised, double-blind, placebo-controlled, phase 3 trial at 25 hospitals and polyclinics in Moscow, Russia. We included participants aged at least 18 years, with negative SARS-CoV-2 PCR and IgG and IgM tests, no infectious diseases in the 14 days before enrolment, and no other vaccinations i...
free text keywords: General Medicine, Articles, Clinical trial, Vaccine efficacy, Interim analysis, Medicine, business.industry, business, Vaccination, Data monitoring committee, Case report form, Placebo, Internal medicine, medicine.medical_specialty, Adverse effect
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