Evidence map›Paper›PMID 34746910›Full record

ArticleThe Lancet regional health. Europe2021

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.

Amir I Tukhvatulin, Inna V Dolzhikova, Dmitry V Shcheblyakov, Olga V Zubkova, Alina S Dzharullaeva, Anna V Kovyrshina, Nadezhda L Lubenets, Daria M Grousova, Alina S Erokhova, Andrei G Botikov and 22 more

Open access · goldAbstract read
In one paragraph

Article in The Lancet regional health. Europe, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 1 synthesis or guideline pooled it, 71 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Developing the next-generation of adenoviral vector vaccines.Human vaccines & immunotherapeutics · 2025
    Review
  4. Article
  5. Molecular mechanisms of SARS-CoV-2 entry: implications for biomedical strategies.Microbiology and molecular biology reviews : MMBR · 2025
    Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Virosome: An engineered virus for vaccine delivery.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023
    Review
  12. Review
  13. COVID-19 Therapeutics: Use, Mechanism of Action, and Toxicity (Vaccines, Monoclonal Antibodies, and Immunotherapeutics).Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2023
    Review
  14. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors at 3 institutions in 1 country.

Amir I TukhvatulinFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Inna V DolzhikovaFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Dmitry V ShcheblyakovFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Olga V ZubkovaFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Alina S DzharullaevaFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Anna V KovyrshinaFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Nadezhda L LubenetsFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Daria M GrousovaFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Alina S ErokhovaFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Andrei G BotikovFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Fatima M IzhaevaFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Olga PopovaFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Tatiana A OzharovskaiaFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Ilias B EsmagambetovFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Irina A FavorskayaFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Denis I ZrelkinFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Daria V VoroninaFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Dmitry N ShcherbininFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Alexander S SemikhinFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Yana V SimakovaFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Elizaveta A TokarskayaFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Maksim M ShmarovFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Natalia A NikitenkoFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Vladimir A GushchinFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Elena A SmolyarchukFederal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University), Moscow, Russia.
Tatiana G Zubkova"Eco-Safety" Medical Center, St. Petersburg, Russia.
Konstantin A Zakharov"Eco-Safety" Medical Center, St. Petersburg, Russia.
Vasiliy B Vasilyuk"Eco-Safety" Medical Center, St. Petersburg, Russia.
Sergei V Borisevich«48 Central Research Institute» of the Ministry of Defense of the Russian Federation, Moscow Region, Sergiev Posad, Russia.
Boris S NaroditskyFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Denis Y LogunovFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Alexander L GintsburgFederal State Budget Institution "National Research Centre for Epidemiology and Microbiology named after Honorary Academician N F Gamaleya" of the Ministry of Health of the Russian Federation, Moscow, Russia.
Ministry of Health of the Russian Federation · RUSechenov University · RU46th Central Research Institute of the Ministry of Defense of the Russian Federation

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWhile the world is experiencing another wave of COVID-19 pandemic, global vaccination program is hampered by an evident shortage in the supply of licensed vaccines. In an effort to satisfy vaccine demands we developed a new single-dose vaccine based on recombinant adenovirus type 26 (rAd26) vector carrying the gene for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) glycoprotein - "Sputnik Light".

methodsWe conducted an open label, prospective, non-randomised phase 1/2 trial aimed to assess safety, tolerability, and immunogenicity of "Sputnik Light" vaccine in a single center in Russia. Primary outcome measures were antigen-specific humoral immunity (Anti-RBD-SARS-CoV-2 antibodies measured by ELISA on days 1, 10, 28, and 42) and safety (number of participants with adverse events monitored throughout the study). Secondary outcome measures were antigen-specific cellular immunity (measured by antigen-dependent CD4+ and CD8+ T-cell proliferation, number of antigen-specific interferon-γ-producing cells as well as interferon-γ concentration upon antigen restimulation) and change in neutralizing antibodies (measured in SARS-CoV-2 neutralization assay).

findingsMost of the solicited adverse reactions were mild (66

interpretationThe single-dose rAd26 vector-based COVID-19 vaccine "Sputnik Light" has a good safety profile and induces a strong humoral and cellular immune responses both in seronegative and seropositive participants.

fundingRussian Direct Investment Fund.

Identifiers

PMID34746910
PMCPMC8562788
OpenAlexW3210472722

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.