1. 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.
- Author
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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, and Gintsburg AL
- Subjects
- Adolescent, Child, Humans, Prospective Studies, SARS-CoV-2, COVID-19 prevention & control, COVID-19 Vaccines adverse effects
- Abstract
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 Registration: ClinicalTrials.gov, NCT04954092, LP-007632., Competing Interests: AT, ID, AD, DG, OZ, AE, OP, TO, FI, DS, IE, ET, NN, NL, BN, DL and AG report the patents for an immunobiological expression vector, pharmaceutical agent, and a method-of-use to prevent COVID-19. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (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.)
- Published
- 2023
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