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

Tukhvatulin, A.I.; Dolzhikova, I.V.; Dzharullaeva, A.S.; Grousova, D.M.; Kovyrshina, A.V.; Zubkova, O.V.; Zorkov, I.D.; Iliukhina, A.A.; Shelkov, A.Y.; Erokhova, A.S.; Popova, O.; Ozharovskaia, T.A.; Zrelkin, D.I.; Izhaeva, F.M.; Shcheblyakov, D.V.; Esmagambetov, I.B.; Tokarskaya, E.A.; Nikitenko, N.A.; Lubenets, N.L.; Khadorich, E.A.; Gushchin, V.A.; Borzakova, S.N.; Vlasova, A.V.; Osmanov, I.M.; Gorev, V.V.; Naroditsky, B.S.; Logunov, D.Y.; Gintsburg, A.L.

Авторы: Tukhvatulin Amir I., Dolzhikova Inna V., Dzharullaeva Alina S., Grousova Daria M., Kovyrshina Anna V., Zubkova Olga V., Zorkov Ilya D., Iliukhina Anna A., Shelkov Artem Y., Erokhova Alina S., Popova Olga, Ozharovskaia Tatiana A., Zrelkin Denis I., Izhaeva Fatima M., Shcheblyakov Dmitry V., Esmagambetov Ilias B., Tokarskaya Elisaveta A., Nikitenko Natalia A., Lubenets Nadezhda L., Khadorich Elizaveta A., Gushchin Vladimir A., Borzakova Svetlana N., Vlasova Anna V., Osmanov Ismail M., Gorev Valerii V., Naroditsky Boris S., Logunov Denis Y., Gintsburg Alexander L.
Журнал: Frontiers in immunology
Том: 14
Год издания: 2023
Издательство: Frontiers Research Foundation]
Местоположение издательства: [Lausanne, Switzerland
DOI: 10.3389/fimmu.2023.1228461
Аннотация: 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.
Добавил в систему: Гущин Владимир Алексеевич

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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 studyстатья