SARS-CoV-2 Antibody and T Cell Response after a Third Vaccine Dose in Hemodialysis Patients Compared with Healthy Controls

  1. Benedikt Simon
  2. Harald Rubey
  3. Martin Gromann
  4. Astrid Knopf-Völkerer
  5. Boris Hemedi
  6. Sonja Zehetmayer
  7. Bernhard Kirsch

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Abstract

Hemodialysis (HD) patients have an increased risk of severe SARS-CoV-2 infection. In this study, we assess the impact of a third vaccine dose (3D) on antibody levels and T cell response in HD patients and a healthy control group in a prospective cohort study consisting of 60 HD patients and 65 healthy controls. Each participant received two doses of the BNT-162b2 mRNA vaccine and an mRNA vaccine 3D. The SARS-CoV-2 antibody response was measured 6 months after the second vaccine dose and 6 to 8 weeks after the 3D. We assessed INF-γ secretion 6–8 weeks post 3D in 24 healthy controls, 17 HD patients with a normal response, and 20 low responder HD patients. The groups were compared using univariate quantile regressions and multiple analyses. After the 3D, the SARS-CoV-2-specific antibody and INF-γ titers of most HD patients were comparable to those of healthy controls. A subgroup of HD patients who had shown a diminished antibody response after the first two vaccine doses developed a significantly lower antibody and INF-γ response compared to responder HD patients and controls even after the 3D. A new strategy is needed to protect low/non-responder HD patients from severe SARS-CoV-2 infection.

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  1. Version published to 10.3390/vaccines10050694
  2. ScreenIT

    SciScore for 10.1101/2022.03.16.22272527: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The study protocol was approved by the local ethics committee.
    Consent: Written informed consent was obtained.
    Sex as a biological variablePregnant women and individuals with known SARS-CoV-2 infection in the past (diagnosed via patient history and test for nucleocapsid (N) antibody, see Section 2.3.2) were excluded from the study.
    RandomizationSome were then randomly selected to receive an INF-γ release assay (IGRA) test due to the limited availability of test kits.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    We conducted a prospective cohort study to elucidate the antibody and INF-γ response to vaccination with Comirnaty (BNT-162b2, BioNTech/Pfizer, two doses) and a booster dose of an mRNA vaccine (either Spikevax (mRNA-1273), Moderna or Comirnaty) administered 6 months after the second vaccine dose in HD patients versus healthy controls vaccinated with the same regimen.
    BNT-162b2
    suggested: None
    The antibody response elicited by vaccination was measured using an Elecsys ® Anti-SARS-CoV-2 S on a Cobas e 801 platform according to specifications, diluted 100-fold.
    Anti-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: We detected the following sentences addressing limitations in the study:
    This could be viewed as a limitation; however, antibody titers are relevant, as demonstrated by recent studies focusing on the correlates of protection from severe infection. In nonhuman primates, after mRNA vaccine immunization16 and in adoptive transfer studies17, antibodies were identified as one such correlate. The assay we used in this paper, an RBD-specific S antibody ELISA, not only correlates with neutralization tests, it was concluded that S-specific and/or RBD-specific antibody tests can be used as a correlate of protection from severe infection16. This conclusion is further reinforced by data on immunization with the AstraZeneca18 and mRNA-127319 vaccines. Another study showed a better correlation of the vaccine efficacy of seven different COVID-19 vaccines with binding (S) antibody titers than with neutralization assays20. It also provides data from human monoclonal therapy that proves the protective role of antibodies in COVID-1920. The RBD antibody test used in our study also showed good correlation with the WHO International Standard and Reference Panel for anti-SARS-CoV-2 antibody21,22, thus providing standardized results. Cut-offs to quantify antibody titers were determined as in our previous study7 according to correlation with a neutralization test10. Briefly, a serum antibody titer of 29 U/ml 3 weeks after the second vaccine dose was used as the cut-off to divide responder HD patients and low/non-responder HD patients. We feel that these data support the u...

    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

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  3. Version published to 10.1101/2022.03.16.22272527v1 on medRxiv