Haemodialysis patients show a highly diminished antibody response after COVID-19 mRNA vaccination compared with healthy controls

  1. Benedikt Simon
  2. Harald Rubey
  3. Andreas Treipl
  4. Martin Gromann
  5. Boris Hemedi
  6. Sonja Zehetmayer
  7. Bernhard Kirsch

Reviewed by

Read the full article

Listed in

Log in to save this article

Abstract

Background

Haemodialysis (HD) patients are exposed to a high risk due to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. They are prone to acquiring the infection and are threatened by high mortality rates in case of infection. However, HD patients were not included in the efficacy trials of the SARS-CoV-2 vaccines. Such efficacy data would have been critical because HD patients show decreased responses against various other vaccines and this could translate to the SARS-CoV-2 vaccines as well.

Methods

We conducted a prospective cohort study that contained a group of 81 HD patients and 80 healthy controls. All of them had been vaccinated with the BioNTech/Pfizer mRNA vaccine (two doses, as per the manufacturer’s recommendation). The anti-SARS-CoV-2 spike (S) antibody response was measured for all participants 21 days after the second dose. The groups were compared using univariate quantile regressions and a multivariate analysis. The adverse events (AEs) of the vaccination were assessed via a questionnaire. Finally, a correlation between the HBs-antibody response and the SARS-CoV-2 antibody response in the HD patients was established.

Results

The HD patients had significantly lower anti-SARS-CoV-2 S antibody titres than the control patients 21 days after vaccination (median was 171 U/mL for dialysis patients and 2500 U/mL for the controls). Further, the HD group presented fewer AEs than the control group. No correlation was found between the antibody response to previous Hepatitis B vaccination and that of the SARS-CoV-2 vaccine.

Conclusions

HD patients present highly diminished SARS-CoV-2 S antibody titres compared with a cohort of controls. Therefore, they could be much less protected by SARS-CoV-2 mRNA vaccinations than expected. Further studies to test alternative vaccination schemes should be considered.

Article activity feed

  1. Version published to 10.1093/ndt/gfab179
  2. ScreenIT

    SciScore for 10.1101/2021.03.26.21254259: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study protocol was approved by the local Ethics committee and participants were enrolled after written informed consent was obtained.
    Consent: The study protocol was approved by the local Ethics committee and participants were enrolled after written informed consent was obtained.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablePregnant women and individuals with known COVID19 infection in the past (diagnosed via patient history and serological test for nucleocapsid (N) antibody, see 2.3 Serological assessment) were excluded from the study.

    Table 2: Resources

    Antibodies
    SentencesResources
    The antibody response elicited by vaccination with BNT62b2 was measured using an Elecsys ® Anti-SARS-CoV-2 S on a Cobas e 801 platform according to specifications[13].
    Anti-SARS-CoV-2
    suggested: None
    Software and Algorithms
    SentencesResources
    [15] Boxplots were generated using Prism (GraphPad, 2021 version; Prism -GraphPad).
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)
    Prism
    suggested: (PRISM, RRID:SCR_005375)
    Microsoft, included in Office 365; Microsoft Excel, Tabellenkalkulationssoftware
    Microsoft Excel
    suggested: (Microsoft Excel, RRID:SCR_016137)

    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:
    One limitation of our study is that the clinical significance of even a plaque-based neutralization assay has not been widely tested; it is probable, but not yet proven, that high antibody titres in our test system and, by correlation, in neutralization assays protect patients from severe infection courses. Further studies are needed to validate the impact of protective antibody titres in clinical settings. Another limitation in this regard is that our test system only tested humoral (antibody), but no cellular (T-cell) immune response. Since the correlates of protection in SARS CoV-2 infection remain unknown as of this date, the cellular part of the adaptive immune system probably plays a role in protection from COVID-19[28] which is not reflected in our investigation. In summary, our data show that the hemodialysis patients in our study, who are at a very high risk for infection with COVID-19 and severe course of disease and mortality[5–7,29], developed an antibody response which is significantly lower than the antibody response in our control group. This finding has implications for preventative measures beyond vaccination (masks, social distancing and hand hygiene, testing strategies, patient isolation etc.) which need to be maintained for protection. Further studies for alternative vaccination strategies (dosing, schedule) are urgently needed.

    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.

    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.

  3. Version published to 10.1101/2021.03.26.21254259v1 on medRxiv