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

Frontiers in Immunology

Immunology

Ismail M. Osmanov¹  Svetlana N. Borzakova¹  Ilya D. Zorkov²  Daria M. Grousova²  Natalia A. Nikitenko²  Tatiana A. Ozharovskaia²  Vladimir A. Gushchin²  Alina S. Dzharullaeva²  Olga V. Zubkova²  Boris S. Naroditsky²  Anna V. Kovyrshina²  Nadezhda L. Lubenets²  Amir I. Tukhvatulin²  Inna V. Dolzhikova²  Elisaveta A. Tokarskaya²  Fatima M. Izhaeva²  Dmitry V. Shcheblyakov²  Ilias B. Esmagambetov²  Artem Y. Shelkov²  Denis I. Zrelkin²  Anna A. Iliukhina²  Elizaveta A. Khadorich²  Olga Popova²  Alina S. Erokhova²  Denis Y. Logunov³  Alexander L. Gintsburg³  Valerii V. Gorev⁴  Anna V. Vlasova⁴ 

[1] Children’s City Clinical Hospital named after Z. A. Bashlyaeva, Moscow City Health Department, Moscow, Russia;Federal State Budget Institution “National Research Centre for Epidemiology and Microbiology Named After Honorary Academician N. F. Gamaleya”, Ministry of Health of the Russian Federation, Moscow, Russia;Federal State Budget Institution “National Research Centre for Epidemiology and Microbiology Named After Honorary Academician N. F. Gamaleya”, Ministry of Health of the Russian Federation, Moscow, Russia;Sechenov First Moscow State Medical University, Ministry of Health of the Russian Federation, Moscow, Russia;Morozov Children’s City Clinical Hospital, Moscow Health Department, Moscow, Russia;

关键词: Sputnik M;    Sputnik V;    Gam-COVID-Vac;    SARS-CoV-2;    COVID-19;   

DOI  :  10.3389/fimmu.2023.1228461

 received in 2023-05-24, accepted in 2023-07-11,  发布年份 2023

来源: Frontiers

【 摘 要 】

To protect young individuals against SARS-CoV-2 infection, we conducted an open-label, prospective, non-randomised dose-escalation Phase 1/2 clinical trial to evaluate the immunogenicity and safety of the prime-boost “Sputnik V” vaccine administered at 1/10 and 1/5 doses to adolescents aged 12–17 years. The study began with the vaccination of the older cohort (15-to-17-year-old participants) with the lower (1/10) dose of vaccine and then expanded to the whole group (12-to-17-year-old participants). Next, 1/5 dose was used according to the same scheme. Both doses were well tolerated by all age groups. No serious or severe adverse events were detected. Most of the solicited adverse reactions were mild. No significant differences in total frequencies of adverse events were registered between low and high doses in age-pooled groups (69.6% versus 66.7%). In contrast, the 1/5 dose induced significantly higher humoral and T cell-mediated immune responses than the 1/10 dose. The 1/5 vaccine dose elicited higher antigen-binding (both S and RBD-specific) as well as virus-neutralising antibody titres at the maximum of response (day 42), also resulting in a statistically significant difference at a distanced timepoint (day 180) compared to the 1/10 vaccine dose. Higher dose resulted in increased cross-neutralization of Delta and Omicron variants.;Clinical Trial RegistrationClinicalTrials.gov, NCT04954092, LP-007632.

【 授权许可】

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Copyright © 2023 Tukhvatulin, Dolzhikova, Dzharullaeva, Grousova, Kovyrshina, Zubkova, Zorkov, Iliukhina, Shelkov, Erokhova, Popova, Ozharovskaia, Zrelkin, Izhaeva, Shcheblyakov, Esmagambetov, Tokarskaya, Nikitenko, Lubenets, Khadorich, Gushchin, Borzakova, Vlasova, Osmanov, Gorev, Naroditsky, Logunov and Gintsburg