Immunogenicity of SARS-CoV-2 Vaccine in Dialysis

  1. Eduardo Lacson
  2. Christos P. Argyropoulos
  3. Harold J. Manley
  4. Gideon Aweh
  5. Andrew I. Chin
  6. Loay H. Salman
  7. Caroline M. Hsu
  8. Doug S. Johnson
  9. Daniel E. Weiner

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Abstract

In this retrospective observational evaluation of SARS-CoV-2 mRNA vaccine seroresponse defined by levels of Ig-G against the receptor-binding domain of the S1 subunit of SARS-CoV-2 spike antigen ≥2 U/L in patients receiving maintenance dialysis, 165 out of 186 (88.7%) were responsive (with 70% at maximum titer) ≥14 days after completing the second dose. This early study suggests that, despite the possibly reduced immunogenicity among patients on dialysis, the short-term incidence of development of antispike antibody is good, giving hope that most of these patients who are vulnerable, once immunized, will be protected from COVID-19. Longer-term evaluation is needed to determine the durability of this protection, the role of repeating vaccine series in initial nonresponders, and the role of booster doses among responders.

Background

Patients receiving maintenance dialysis represent a high-risk, immune-compromised population with 15%–25% COVID-19 mortality rate who were unrepresented in clinical trials of mRNA vaccines.

Methods

All patients receiving maintenance dialysis who received two doses of SARS-CoV-2 mRNA vaccines with antibody test results drawn ≥14 days after the second dose, as documented in the electronic health record through March 18, 2021, were included. Response was on the basis of levels of Ig-G against the receptor binding domain of the S1 subunit of SARS-CoV-2 spike-antigen (seropositive ≥2 U/L) using an FDA-approved semiquantitative chemiluminescent assay (ADVIA Centaur XP/XPT COV2G).

Results

Among 186 patients on dialysis from 30 clinics in eight states tested 23±8 days after receiving two vaccine doses, there were 165 (88.7%) responders with 70% at maximum titer. There was no significant difference between BNT162b2/Pfizer (148 out of 168, 88.1%) and mRNA-1273/Moderna (17 out of 18, 94.4%), P =0.42. All 38 patients with COVID-19 history were responders, with 97% at maximum titer. Among patients without COVID-19, 127 out of 148 (85.8%) were responders, comparable between BNT162b2/Pfizer (113 out of 133) and mRNA-1273/Moderna (14 out of 15) vaccines (85.0% versus 93.3%, P =0.38).

Conclusions

Most patients receiving maintenance dialysis responded after two doses of BNT162b2/Pfizer or mRNA-1273/Moderna vaccine, suggesting the short-term development of antispike antibody is good, giving hope that most of these patients who are vulnerable, once immunized, will be protected from COVID-19. Longer-term evaluation is needed to determine antibody titer durability and if booster dose(s) are warranted. Further research to evaluate the approach to patients without a serologic response is needed, including benefits of additional dose(s) or administration of alternate options.

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  1. Version published to 10.1681/asn.2021040432
  2. ScreenIT

    SciScore for 10.1101/2021.04.08.21254779: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: This retrospective evaluation is a DCI quality improvement evaluation under Western Institutional Review Board (WIRB) exemption.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical analyses were performed using SAS v9.4.
    SAS
    suggested: (SASqPCR, RRID:SCR_003056)

    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:
    Additional limitations include an observational design that may have led to residual confounding and selection biases, heavily influenced by accessibility and availability of vaccines. Future studies could also evaluate T-cell responses given that specific clinical implications of serology tests including the SAb-IgG we utilized, need further elucidation. In conclusion, the vast majority of maintenance dialysis patients responded with IgG spike antibody titers to a complete series of both SARS-CoV-2 mRNA BNT162b2 and mRNA-1273 vaccines. Further study is needed to determine duration of the seroprotection as well as the ideal approach to non-responders, including whether they should receive a booster dose. Early evidence suggests that vaccinated dialysis patients with prior COVID-19 develop robust antibody response. Our findings support an equitable and aggressive vaccination strategy for all eligible maintenance dialysis patients regardless of age, sex, race, ethnicity, or disability, to prevent the extremely high morbidity and mortality associated with COVID-19 in this high risk population.

    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

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  3. Version published to 10.1101/2021.04.08.21254779v1 on medRxiv