Impact of tozinameran (BNT162b2) mRNA vaccine on kidney transplant and chronic dialysis patients: 3–5 months follow-up

  1. Iddo Z. Ben-Dov
  2. Yonatan Oster
  3. Keren Tzukert
  4. Talia Alster
  5. Raneem Bader
  6. Ruth Israeli
  7. Haya Asayag
  8. Michal Aharon
  9. Ido Burstein
  10. Hadas Pri-Chen
  11. Ashraf Imam
  12. Roy Abel
  13. Irit Mor-Yosef Levi
  14. Abed Khalaileh
  15. Esther Oiknine-Djian
  16. Aharon Bloch
  17. Dana G. Wolf
  18. Michal Dranitzki Elhalel

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Abstract

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  1. Version published to 10.1007/s40620-021-01210-y
  2. Version published to 10.1101/2021.06.12.21258813v2 on medRxiv
  3. ScreenIT

    SciScore for 10.1101/2021.06.12.21258813: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: Clinical methods: Blood samples were taken from dialysis and transplant patients during routine visits, after obtaining informed consent, at several designated time-windows during the vaccination period: at baseline (namely, before administration of the first vaccine dose), 10-20 days after the first vaccine, 2-6 weeks after the second vaccine inoculation (typically scheduled 21 days after the first inoculation) and 3 months or longer after the first vaccination.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Anti-SARS-2 IgG antibodies were quantified using LIAISON SARS-CoV-2 S1/S2 IgG (DiaSorin) and ARCHITECT SARS-CoV-2 IgG II (Abbott) immunoassays, and the former kit results are reported here.
    Anti-SARS-2 IgG
    suggested: None
    Right-skewed variables (e.g. antibody titers) were log10-transformed prior to statistical testing.
    e.g.
    suggested: None
    Software and Algorithms
    SentencesResources
    Anti-SARS-2 IgG antibodies were quantified using LIAISON SARS-CoV-2 S1/S2 IgG (DiaSorin) and ARCHITECT SARS-CoV-2 IgG II (Abbott) immunoassays, and the former kit results are reported here.
    Abbott
    suggested: (Abbott, RRID:SCR_010477)
    Model outputs are presented using the sjPlot package19.
    sjPlot
    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: We detected the following sentences addressing limitations in the study:
    There are several limitations to our study. This is a single center study, and may not represent the larger ESRD community when considering future vaccination policy, although we believe that the study is large enough to facilitate further research. A longer follow-up period can enrich the data on antibody titers, although the dramatic rapid decline in COVID-19 prevalence in Israel means that hopefully little new data regarding protectivity will be available. Additionally, COVID-19 infection was defined as positive PCR, regardless of symptoms, but routine screening was not done, and therefore we might have missed several asymptomatic patients. Lastly, we did not report in this study ongoing investigation of cellular immunity or non-IgG antibodies which could add to our understanding of the immune response and protection after vaccination. In conclusion, we show that ESRD patients exhibit impaired humoral response to two doses of tozinameran, a prototype of mRNA vaccination, manifested either by negative ELISA or lower titers than those of the healthy controls. Of note, a small rise in antibody levels and proportion of responding patiens is evident after three months, suggesting a different time scale of the immune response. Additionally, we show inverse association of IgG titers with the risk of contracting COVID-19 after vaccination. We suggest testing immune-compromised patients for COVID-19 IgG antibodies in order to identify high-risk patients, and to expand research rega...

    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.

  4. Version published to 10.1101/2021.06.12.21258813v1 on medRxiv