SARS-CoV-2 Infection during the Omicron Surge among Patients Receiving Dialysis: The Role of Circulating Receptor-Binding Domain Antibodies and Vaccine Doses

  1. Maria E. Montez-Rath
  2. Pablo Garcia
  3. Jialin Han
  4. LinaCel Cadden
  5. Patti Hunsader
  6. Curt Morgan
  7. Russell Kerschmann
  8. Paul Beyer
  9. Mary Dittrich
  10. Geoffrey A. Block
  11. Julie Parsonnet
  12. Glenn M. Chertow
  13. Shuchi Anand

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Abstract

As the SARS-CoV-2 pandemic enters a potentially endemic phase, with fewer community-level mitigation approaches, clinical parameters that indicate heightened infection risk can guide targeted provision of additional vaccine doses, or other protective measures, among patients receiving dialysis. In our prospective cohort study of 3576 patients, three doses of mRNA vaccines enhanced protection against infection during the Omicron-dominant period in the United States. Irrespective of number of vaccine doses, however, patients with circulating receptor-binding domain semiquantitative index values <506 BAU/ml had a two- to three-fold higher risk for infection than patients with higher values. Low circulating antibody levels can inform need and timing of further vaccine doses or monoclonal antibodies to reduce risk for SARS-CoV-2 infection among patients receiving dialysis.

Background

It is unclear whether circulating antibody levels conferred protection against SARS-CoV-2 infection among patients receiving dialysis during the Omicron-dominant period.

Methods

We followed monthly semiquantitative SARS-CoV-2 RBD IgG index values in a randomly selected nationwide cohort of patients receiving dialysis and ascertained SARS-CoV-2 infection during the Omicron-dominant period of December 25, 2021 to January 31, 2022 using electronic health records. We estimated the relative risk for documented SARS-CoV-2 infection by vaccination status and by circulating RBD IgG using a log-binomial model accounting for age, sex, and prior COVID-19.

Results

Among 3576 patients receiving dialysis, 901 (25%) received a third mRNA vaccine dose as of December 24, 2021. Early antibody responses to third doses were robust (median peak index IgG value at assay limit of 150). During the Omicron-dominant period, SARS-CoV-2 infection was documented in 340 (7%) patients. Risk for infection was higher among patients without vaccination and with one to two doses (RR, 2.1; 95% CI, 1.6 to 2.8, and RR, 1.3; 95% CI, 1.0 to 1.8 versus three doses, respectively). Irrespective of the number of vaccine doses, risk for infection was higher among patients with circulating RBD IgG <23 (506 BAU/ml) (RR range, 2.1 to 3.2, 95% CI, 1.3 to 3.4 and 95% CI, 2.2 to 4.5, respectively) compared with RBD IgG ≥23.

Conclusions

Among patients receiving dialysis, a third mRNA vaccine dose enhanced protection against SARS-CoV-2 infection during the Omicron-dominant period, but a low circulating RBD antibody response was associated with risk for infection independent of the number of vaccine doses. Measuring circulating antibody levels in this high-risk group could inform optimal timing of vaccination and other measures to reduce risk of SARS-CoV-2 infection.

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  1. Version published to 10.1681/asn.2022040504
  2. ScreenIT

    SciScore for 10.1101/2022.03.15.22272426: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: Stanford University investigators received anonymized data, and the Institutional Review Board waived the requirement for consent.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Laboratory Testing for RBD Antibodies: We tested remainder samples using the Siemens total RBD Ig assay, which measures IgG and IgM antibodies.
    IgM
    suggested: None
    Software and Algorithms
    SentencesResources
    Statistical analyses were conducted using SAS, version 9.4 (SAS Institute), or Stata/MP 17 (StataCorp).
    SAS
    suggested: (SASqPCR, RRID:SCR_003056)
    StataCorp
    suggested: (Stata, RRID:SCR_012763)

    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: 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 10.1101/2022.03.15.22272426v2 on medRxiv
  4. Version published to 10.1101/2022.03.15.22272426v1 on medRxiv