Trial reportFrontiers in immunology2026
Sputnik V update: safety and neutralizing antibodies in healthy adults and adolescents.
Trial report in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Safety, Reactogenicity and Immunogenicity Study of the Vector Vaccine GamCovidVac-M for the Prevention of Coronavirus (COVID-19) Infection Caused by the SARS-CoV-2 Virus With Altered Antigenic Composition With Participation of 12-17 Years Old Volunteers.
Safety, Reactogenicity and Immunogenicity Study of the Vector Vaccine GamCovidVac for the Prevention of Coronavirus (COVID-19) Infection Caused by the SARS-CoV-2 Virus With Altered Antigenic Profile With Participation of Adult Volunteers
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37 authors.
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Abstract
Background: During the COVID-19 pandemic, adenoviral vector-based Sputnik V vaccine was used to vaccinate the civilian population of 74 countries worldwide. As part of laboratory monitoring of the effectiveness of the Sputnik V vaccine, a decrease in effectiveness was detected against Omicron BA.5 and XBB variants. XBB variant quickly displaced all previously circulating variants, so the antigen composition of the Sputnik V vaccine was changed to the XBB variant. Methods: The Gam-COVID-Vac XBB (Sputnik V XBB) vaccine was developed, manufactured, and stored by Gamaleya NRCEM (Moscow, Russia). Two open prospective clinical study of the safety, reactogenicity and immunogenicity of the Sputnik V XBB vaccine was conducted in 50 adult participants over 18 years old and 50 adolescent participants 12-17 years old (ClinicalTrials.gov Identifier: NCT06068569 and NCT06068556). Immunogenicity study included ELISA assay for detection glycoprotein S of the Omicron XBB variant and neutralization assay with viable SARS-CoV-2 virus Omicron ХВВ.1.5, ХВВ.1.9.1, ХВВ.1.16, EG.5.1, ВА.2.86, JN.1, KS.1, XFG.3, NY.2 and PY.2 variants. Results: Safety profile of the Sputnik V XBB vaccine was consistent with the previous formulation, and no new safety concerns were reported. There were no cases of serious AEs. Seroconversion of antigen-specific IgG on day 42 was 100% in adults and 87.5% in adolescents. We showed robust NtAb response to circulating SARS-CoV-2 variants (ХВВ.1.5, ХВВ.1.9.1, ХВВ.1.16, EG.5.1, ВА.2.86, JN.1, KS.1, XFG.3, NY.2 and PY.2) in vaccinated adults and adolescents, seroconversion rate of NtAb against any circulating variant was 96% in adults and 94% in adolescents. Conclusion: The results of the clinical trials demonstrated a favorable safety profile and a high level of immunogenicity of Sputnik V XBB in adults and adolescents. Clinical Trial Registration: ClinicalTrials.gov, identifiers NCT06068569 and NCT06068556.
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