Study of Gam-COVID-Vac in Adolescents

Summary

Double-blind, placebo-controlled study with open dose selection period for safety assessment, tolerance and immunogenicity of the drug "GamKOVID-Vac M, a combined vector vaccine for prevention of coronavirus infection caused by the virus SARS-CoV-2" in adolescents

Timeline

Start

2021-07-05

Primary completion

2022-11-06

Completion

2023-12-31

Publications

• Tukhvatulin AI, Dolzhikova IV, Dzharullaeva AS, Grousova DM, Kovyrshina AV, Zubkova OV, Zorkov ID, Iliukhina AA, Shelkov AY, Erokhova AS, Popova O, Ozharovskaia TA, Zrelkin DI, Izhaeva FM, Shcheblyakov DV, Esmagambetov IB, Tokarskaya EA, Nikitenko NA, Lubenets NL, Khadorich EA, Gushchin VA, Borzakova SN, Vlasova AV, Osmanov IM, Gorev VV, Naroditsky BS, Logunov DY, Gintsburg AL. Safety and immunogenicity of rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine against SARS-CoV-2 in healthy adolescents: an open-label, non-randomized, multicenter, phase 1/2, dose-escalation study. Front Immunol. 2023 Aug 1;14:1228461. doi: 10.3389/fimmu.2023.1228461. eCollection 2023.

Drugs

Indications