Safety and Effectiveness of COVID-19 SPUTNIK V Vaccine in Dialysis Patients

  1. Guillermo Rosa-Diez
  2. María Marina Papaginovic Leiva
  3. Fernando Lombi
  4. María Soledad Crucelegui
  5. Ricardo Dulio Martínez
  6. Hernán Trimarchi
  7. Rubén Schiavelli
  8. Mercedes Grizzo
  9. Miguel Raño
  10. Ricardo M. Heguilén
  11. Rocío Anahí Jones
  12. Luciana Gonzalez Paganti
  13. Matías Ferrrari
  14. Dra. Paula Zingoni
  15. Victoria Kjohede
  16. Jorge Raúl Geffner
  17. Daniel Ferrante
  18. Fernán González Bernaldo de Quirós
  19. Vanina Pagotto

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Abstract

Given the vulnerability of people with chronic kidney disease to COVID-19, nephrology societies have issued statements calling for prioritization of these patients for vaccination. It is not yet known whether COVID-19 vaccines confer the same high level of protection in patients with kidney disease. The aims of this study were to evaluate the safety measured by the events supposedly attributed to vaccines and the effectiveness evaluated by the presence of antibodies in dialysis patients immunized with the COVID-19 Sputnik V vaccine.

Methods

multicenter, observational and analytical study of a prospective cohort of hemodialysis patients in the Autonomous City of Buenos Aires with a vaccination plan. Patients older than 18 years on dialysis who received both components of the COVID-19 vaccine were included.

Results

491 patients included in the safety analysis. ESAVI with either the first or second component was detected in 186 (37.9% 95% CI 33.6%-42.34%). The effectiveness analysis measures of antibodies against SARS-Cov-2 were performed in 102 patients, 98% had positive IgG against SARS-Cov-2 antibodies 21 days after the second component .In patients with COVID-19 prior to vaccination, antibodies at day 21 after the first component reached almost the highest levels compared to those patients who did not have COVID-19, and the rise between the last measures was lower than patients without COVID-19.

Conclusion

Dialysis patients constitute a vulnerable population for SARS-Cov-2 infection, beyond the recommendations that were implemented by dialysis units, full vaccination is a priority and necessary. The Sputnik V vaccine has been shown to be safe and effective in this patient population.

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  1. ScreenIT

    SciScore for 10.1101/2021.10.21.21265349: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: Ethics statement: The study was approved by the Ethics Committee of the Alberto C Taquini Institute for Translational Medicine Research of the Faculty of Medicine of the University of Buenos Aires.
    Consent: For the effectiveness study, based on the measurement of antibodies, informed consent was requested.
    Field Sample Permit: The analysis was carried out with software R version 4.0.3 Funding source: The COVIDAR group provided the Serokits for sampling and the ELISA COVIDAR IgG kits, supported by FOCEM and Asoc. SAND. None of the funding sources provided economical support for the data collection, statistical analysis, or were used to write the manuscript, or to submit it for publication.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power AnalysisFor the effectiveness objective considering the publication of the published phase 1/2 results of the Sputnik V vaccine study(2) and assuming that the vaccinated population in Buenos Aires will have the same behavior as published, the following sample scenarios were evaluated: a) For a delta of IgG antibody titers between 0 and 21 days of 1.24 with a standard deviation of 1 with a power of 90% and an alpha of 0.01, for a two-tailed hypothesis test.

    Table 2: Resources

    Antibodies
    SentencesResources
    Data referring to the effectiveness was the measurement of antibodies type immunoglobulin G (IgG) against SARS-Cov-2.
    SARS-Cov-2
    suggested: None

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04944433Active, not recruitingSafety and Efficacy of the Coronavirus Disease 2019 Vaccine …

    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 10.1101/2021.10.21.21265349v1 on medRxiv