An open, non-randomised, phase 1/2 trial on the safety, tolerability, and immunogenicity of single-dose vaccine “Sputnik Light” for prevention of coronavirus infection in healthy adults

Tukhvatulin, Amir I.; Dolzhikova, Inna V.; Shcheblyakov, Dmitry V.; Zubkova, Olga V.; Dzharullaeva, Alina S.; Kovyrshina, Anna V.; Lubenets, Nadezhda L.; Grousova, Daria M.; Erokhova, Alina S.; Ботиков, А. Г.; Izhaeva, Fatima M.; Popova, Olga; Ozharovskaia, Tatiana A.; Esmagambetov, Ilias B.; Favorskaya, I. A.; Zrelkin, Denis I.; Voronina, Daria V.; Щербинин, Д Н; Семихин, А. С.; Simakova, Yana V.; Tokarskaya, Elizaveta A.; Шмаров, М. М.; Никитенко, Н. А.; Гущин, В.А.; Smolyarchuk, E. A.; Zubkova, Tatiana G.; Zakharov, Konstantin; Vasilyuk, Vasiliy B.; Борисевич, С. В.; Naroditsky, Boris S.; Logunov, Denis Y.; Gintsburg, Alexander L.

doi:10.1016/j.lanepe.2021.100241

Cited by 54 publications

(48 citation statements)

References 17 publications

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“…BAU/мл. К 42 дню сероконверсия, соответственно, составила 92,9%, антиген-специфический клеточный иммунитет развил-ся у 100% серопозитивных и 96% серонегативных добровольцев [10].…”

Section: Discussionunclassified

Long-term dynamics of the levels of anti-SARS-CoV-2 S-protein IgG antibodies in vaccinated individuals

Drapkina¹,

Бернс²,

Gorshkov³

et al. 2022

Cardiovasc Ther Prev

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In the context of the ongoing coronavirus disease 2019 (COVID-19) pandemic, it is extremely important to study immunogenicity and immune response duration in different vaccines.Aim. As part of a prospective observational study, to study the levels of anti-SARS-CoV-2 S-protein IgG antibodies in individuals vaccinated with the Gam-COVID-Vac and CoviVac vaccines.Material and methods. The data of 93 people who completed the first 3 visits were analyzed, 23 of whom were vaccinated with the Gam-COVID-Vac vaccine and 70 people — with the CoviVac vaccine. We collected blood before the injection of vaccine doses I and II, as well as 42 days after the injection of dose I in order to quantitatively determine IgG levels. The level of anti-SARS-CoV-2 S-protein IgG antibodies was determined using the SARS-CoV-2 IgG ELISA-BEST reagent kit on the InfiniteF50 TECAN system.Results. A significant increase in anti-SARS-CoV-2 S-protein IgG antibodies was observed in those vaccinated with Gam-COVID-Vac. In the group of CoviVac vaccine, an increase in the level anti-SARS-CoV-2 S-protein IgG antibodies in absolute values was recorded, however, this increase did not reach statistical significance.Conclusion. The data obtained show that the level of anti-SARS-CoV-2 S-protein antibodies 42 days after Gam-COVID-Vac vaccination is significantly higher than after CoviVac vaccination. However, an increase in the level of IgG in both groups indicates the ability of both vaccines to stimulate the production of anti-SARS-CoV antibodies.

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Section: Discussionunclassified

Long-term dynamics of the levels of anti-SARS-CoV-2 S-protein IgG antibodies in vaccinated individuals

Drapkina¹,

Бернс²,

Gorshkov³

et al. 2022

Cardiovasc Ther Prev

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“…Negative immunity following the first dose of the Sputnik vaccine has been reported in several recent studies, with the main dermatological side effects being urticarial rashes [ 10 – 12 ] . We are the first to report a severe persistent eczematous reaction following injection of the first dose of the Sputnik vaccine.…”

Section: Discussionmentioning

confidence: 99%

Severe Persistent Eczema in a Recipient of the Gam-COVID-Vac vaccine

Ameri

Abolmaali

Alwedaie³

et al. 2022

European Journal of Case Reports in Internal Medicine

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Since the beginning of the COVID-19 pandemic, efforts have been made to design safe and effective vaccines against SARS-CoV-2. Numerous vaccines have been designed and tested in limited clinical trials in various countries. Among them, the Sputnik V vaccine has shown a relatively safe profile and, to our knowledge, has no associated major side effects. We describe the case of a 40-year-old female healthcare worker who developed severe persistent eczematous lesions on the second day after she received the first dose of the Sputnik vaccine. The eczematous lesions were refractory to an antihistamine and persisted at the 1 month follow-up. Severe persistent eczematous lesions should be viewed as a potential side effect of vaccination with the Sputnik V vaccine. Moreover, a severe allergic reaction to a COVID-2019 vaccine may indicate the vaccine is ineffective in the recipient.

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“…Unlike Ad26.COV2.S, which encodes prefusion-stabilized S, rAd26 carries the gene for native SARS-CoV-2 s S protein (rAd26-S). For seropositive individuals, a single 1 × 10 11 vp immunization of rAd26 elicited higher NAbs than those from convalescent plasma; for seronegative individuals, rAd26 elicited lower NAbs than those from convalescent plasma [34]. Additional studies showed that a single 1 × 10 11 vp immunization of rAd26 or rAd5 elicited NAb titers that were 2-4 fold lower than those from convalescent plasma, and immunizations of the heterologous vaccine based on rAd26 and rAd5 induced higher NAb titers compared with those in convalescent plasma [35].…”

Section: Adenoviral Vectormentioning

confidence: 93%

“…In a "Sputnik light" study, 96% of volunteers showed IFN-γ T cell responses just 10 days after a single shot of rAd26. The median SFC per 10 6 PBMCs was 554.3 spots, which is 3-fold higher than that of Ad26.COV2.S [34]. Interestingly, "Sputnik light", which relies on a prime-only regimen of rAd26, induced similar levels of T cell response in comparison with "Sputnik V", which utilizes both rAd26 and rAd5 in a heterologous prime-boost approach.…”

Section: Cellular Immunitymentioning

confidence: 95%

“…In addition to exploiting the robust immunogenicity of both Ad vectors, this approach strives to circumvent pre-existing Ad immunity which may impede the induction of potent humoral immunity. A phase 1/2 trial conducted in Russia evaluated the immunogenicity of "Sputnik light", a single-dose vaccine based on rAd26 [34]. Unlike Ad26.COV2.S, which encodes prefusion-stabilized S, rAd26 carries the gene for native SARS-CoV-2 s S protein (rAd26-S).…”

Section: Adenoviral Vectormentioning

confidence: 99%

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Fighting Fire with Fire: Immunogenicity of Viral Vectored Vaccines against COVID-19

Chang

2022

Viruses

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The persistent expansion of the coronavirus disease 2019 (COVID-19) global pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) requires the rapid development of safe and effective countermeasures to reduce transmission, morbidity, and mortality. Several highly efficacious vaccines are actively being deployed around the globe to expedite mass vaccination and control of COVID-19. Notably, viral vectored vaccines (VVVs) are among the first to be approved for global distribution and use. In this review, we examine the humoral, cellular, and innate immune responses elicited by viral vectors, and the immune correlates of protection against COVID-19 in preclinical and clinical studies. We also discuss the durability and breadth of immune response induced by VVVs and boosters. Finally, we present challenges associated with VVVs and offer solutions for overcoming certain limitations of current vaccine regimens. Collectively, this review provides the rationale for expanding the portfolio of VVVs against SARS-CoV-2.

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An open, non-randomised, phase 1/2 trial on the safety, tolerability, and immunogenicity of single-dose vaccine “Sputnik Light” for prevention of coronavirus infection in healthy adults

Cited by 54 publications

References 17 publications

Long-term dynamics of the levels of anti-SARS-CoV-2 S-protein IgG antibodies in vaccinated individuals

Long-term dynamics of the levels of anti-SARS-CoV-2 S-protein IgG antibodies in vaccinated individuals

Severe Persistent Eczema in a Recipient of the Gam-COVID-Vac vaccine

Fighting Fire with Fire: Immunogenicity of Viral Vectored Vaccines against COVID-19

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