tetano
Editor, Senior Moderator
Front Immunol
. 2026 Mar 26:17:1736771.
doi: 10.3389/fimmu.2026.1736771. eCollection 2026.
Sputnik V update: safety and neutralizing antibodies in healthy adults and adolescents
Inna V Shuliakova[SUP] 1 [/SUP], Daria M Grousova[SUP] 1 [/SUP], Anna A Iliukhina[SUP] 1 [/SUP], Alina S Dzharullaeva[SUP] 1 [/SUP], Nadezhda L Lubenets[SUP] 1 [/SUP], Maria K Ordzhonikidze[SUP] 1 [/SUP], Fatima M Izhaeva[SUP] 1 [/SUP], Alina S Erokhova[SUP] 1 [/SUP], Ilya D Zorkov[SUP] 1 [/SUP], Valentin V Azizyan[SUP] 1 [/SUP], Zoya D Boeva[SUP] 1 [/SUP], Dmitrii A Reshetnikov[SUP] 1 [/SUP], Irina A Ermolova[SUP] 1 [/SUP], Vladislav A Lega[SUP] 1 [/SUP], Anna V Kovyrshina[SUP] 1 [/SUP], Kirill M Bukhtin[SUP] 1 [/SUP], Lyubov P Romanova[SUP] 1 [/SUP], Ekaterina I Alekseeva[SUP] 2 [/SUP], Svetlana N Borzakova[SUP] 3 [/SUP], Svetlana A Rachina[SUP] 4 [/SUP], Marina G Rusanova[SUP] 5 [/SUP], Tatiana A Ozharovskaia[SUP] 1 [/SUP], Olga Popova[SUP] 1 [/SUP], Denis I Zrelkin[SUP] 1 [/SUP], Olga V Zubkova[SUP] 1 [/SUP], Amir I Tukhvatulin[SUP] 1 [/SUP], Natalia M Tukhvatulina[SUP] 1 [/SUP], Dmitrii V Shcheblyakov[SUP] 1 [/SUP], Irina A Favorskaya[SUP] 1 [/SUP], Ilias B Esmagambetov[SUP] 1 [/SUP], Andrey P Karpov[SUP] 1 [/SUP], Aleksandr S Semikhin[SUP] 1 [/SUP], Andrey A Pochtovyi[SUP] 1 6 [/SUP], Boris S Naroditskiy[SUP] 1 [/SUP], Vladimir A Gushchin[SUP] 1 6 7 [/SUP], Aleksandr L Gintsburg[SUP] 1 3 [/SUP], Denis Y Logunov[SUP] 1 [/SUP]
Affiliations
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.
Keywords: NtAb; SARS-CoV-2; Sputnik V; XBB; vaccine.
. 2026 Mar 26:17:1736771.
doi: 10.3389/fimmu.2026.1736771. eCollection 2026.
Sputnik V update: safety and neutralizing antibodies in healthy adults and adolescents
Inna V Shuliakova[SUP] 1 [/SUP], Daria M Grousova[SUP] 1 [/SUP], Anna A Iliukhina[SUP] 1 [/SUP], Alina S Dzharullaeva[SUP] 1 [/SUP], Nadezhda L Lubenets[SUP] 1 [/SUP], Maria K Ordzhonikidze[SUP] 1 [/SUP], Fatima M Izhaeva[SUP] 1 [/SUP], Alina S Erokhova[SUP] 1 [/SUP], Ilya D Zorkov[SUP] 1 [/SUP], Valentin V Azizyan[SUP] 1 [/SUP], Zoya D Boeva[SUP] 1 [/SUP], Dmitrii A Reshetnikov[SUP] 1 [/SUP], Irina A Ermolova[SUP] 1 [/SUP], Vladislav A Lega[SUP] 1 [/SUP], Anna V Kovyrshina[SUP] 1 [/SUP], Kirill M Bukhtin[SUP] 1 [/SUP], Lyubov P Romanova[SUP] 1 [/SUP], Ekaterina I Alekseeva[SUP] 2 [/SUP], Svetlana N Borzakova[SUP] 3 [/SUP], Svetlana A Rachina[SUP] 4 [/SUP], Marina G Rusanova[SUP] 5 [/SUP], Tatiana A Ozharovskaia[SUP] 1 [/SUP], Olga Popova[SUP] 1 [/SUP], Denis I Zrelkin[SUP] 1 [/SUP], Olga V Zubkova[SUP] 1 [/SUP], Amir I Tukhvatulin[SUP] 1 [/SUP], Natalia M Tukhvatulina[SUP] 1 [/SUP], Dmitrii V Shcheblyakov[SUP] 1 [/SUP], Irina A Favorskaya[SUP] 1 [/SUP], Ilias B Esmagambetov[SUP] 1 [/SUP], Andrey P Karpov[SUP] 1 [/SUP], Aleksandr S Semikhin[SUP] 1 [/SUP], Andrey A Pochtovyi[SUP] 1 6 [/SUP], Boris S Naroditskiy[SUP] 1 [/SUP], Vladimir A Gushchin[SUP] 1 6 7 [/SUP], Aleksandr L Gintsburg[SUP] 1 3 [/SUP], Denis Y Logunov[SUP] 1 [/SUP]
Affiliations
- PMID: 41972135
- PMCID: PMC13062787
- DOI: 10.3389/fimmu.2026.1736771
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.
Keywords: NtAb; SARS-CoV-2; Sputnik V; XBB; vaccine.