Sputnik Light booster after Sputnik V vaccination induces robust neutralizing antibody response to B.1.1.529 (Omicron) SARS-CoV-2 variant

  1. IV Dolzhikova
  2. AA Iliukhina
  3. AV Kovyrshina
  4. AV Kuzina
  5. VA Gushchin
  6. AE Siniavin
  7. AA Pochtovyi
  8. EV Shidlovskaya
  9. NA Kuznetsova
  10. MM Megeryan
  11. AS Dzharullaeva
  12. AS Erokhova
  13. FM Izhaeva
  14. DM Grousova
  15. AG Botikov
  16. DV Shcheblyakov
  17. AI Tukhvatulin
  18. OV Zubkova
  19. DY Logunov
  20. AL Gintsburg

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Abstract

COVID-19 vaccination campaign has been launched around the world. More than 8 billion vaccines doses have been administered, according to the WHO. Published studies shows that vaccination reduces the number of COVID-19 cases and dramatically reduces COVID-19-associated hospitalizations and deaths worldwide. In turn, the emergence of SARS-CoV-2 variants of concern (VOC) with mutations in the receptor-binding domain (RBD) of S glycoprotein poses risks of diminishing the effectiveness of the vaccination campaign. In November 2021, the first information appeared about a new variant of the SARS-CoV-2 virus, which was named Omicron. The Omicron variant is of concern because it contains a large number of mutations, especially in the S glycoprotein (16 mutation in RBD), which could be associated with resistance to neutralizing antibodies (NtAB) and significantly reduce the effectiveness of COVID-19 vaccines. Neutralizing antibodies are one of the important parameters characterizing the protective properties of a vaccine. We conducted a study of neutralizing antibodies in the blood serum of people vaccinated with Sputnik V, as well as those revaccinated with Sputnik Light after Sputnik V. Results showed that a decrease in the level of neutralizing antibodies was observed against SARS-CoV-2 Omicron (B.1.1.529) variant in comparison to B.1.1.1 variant. Analysis of the sera of individuals vaccinated with Sputnik V 6-12 months ago showed that there was a decrease in the level of neutralizing antibodies by 11.76 folds. While no direct comparison with other vaccines declines has been done in this study, we note their reported decline in antibody neutralization at a much more significant level of 40-84 times. At the same time, the analysis of sera of individuals who were vaccinated with Sputnik V, and then revaccinated Sputnik Light, showed that 2-3 months after revaccination the decrease in the level of neutralizing antibodies against the Omicron variant was 7.13 folds. Despite the decrease in NtAb, we showed that all revaccinated individuals had NtAb to Omicron variant. Moreover, the NtAb level to Omicron variant in revaccinated sera are slightly higher than NtAb to B.1.1.1 in vaccinated sera.

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    SciScore for 10.1101/2021.12.17.21267976: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: Ethics statement: The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Local Ethics Committee of Gamaleya NRCEM
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Experimental Models: Cell Lines
    SentencesResources
    The virus was isolated, propagated and titrated on Vero E6 cells in complete DMEM with 2% HI-FBS.
    Vero E6
    suggested: RRID:CVCL_XD71)
    Software and Algorithms
    SentencesResources
    Statistical analysis: Statistical analysis was performed in GraphPad Prism version 9.2.0 (
    GraphPad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)
    GraphPad Software Inc.
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    This study has several limitations: 1) the relatively small number of tested samples, which may not reflect the range of neutralizing antibodies in different groups of vaccinated, 2) limited data on the dynamics over time of neutralizing antibodies to the Omicron variant after vaccination and revaccination. Additional work is currently underway to study the level of neutralizing antibodies in expanded sample sizes, as well as to study the effectiveness of the Sputnik V vaccine against Omicron variant in a lethal model in hACE2-transgenic mice. Further studies are important to understand the effectiveness of COVID-19 vaccines against the new SARS-CoV-2 Omicron variant. If there will be a critical decrease in effectiveness (lower than recommended by WHO), it is necessary to consider change the antigenic composition of the vaccines. In this case, the efficacy of the new vaccine candidate should be studied against Omicron, as well as Delta, the proportion of which remains prevalent.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2021.12.17.21267976 on medRxiv