Seroresponse to SARS-CoV-2 Vaccines among Maintenance Dialysis Patients over 6 Months

  1. Caroline M. Hsu
  2. Daniel E. Weiner
  3. Harold J. Manley
  4. Gideon N. Aweh
  5. Vladimir Ladik
  6. Jill Frament
  7. Dana Miskulin
  8. Christos Argyropoulos
  9. Kenneth Abreo
  10. Andrew Chin
  11. Reginald Gladish
  12. Loay Salman
  13. Doug Johnson
  14. Eduardo K. Lacson

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Abstract

Although most patients receiving maintenance dialysis exhibit initial seroresponse to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination, concerns exist regarding the durability of this antibody response. This study evaluated seroresponse over time.

Design, setting, participants, & measurements

This retrospective cohort study included patients on maintenance dialysis, from a midsize national dialysis provider, who received a complete SARS-CoV-2 vaccine series and had at least one antibody titer checked after full vaccination. IgG spike antibodies (anti-spike IgG) titers were assessed monthly with routine laboratory tests after vaccination; the semiquantitative assay reported a range between zero and ≥20 Index. Descriptive analyses compared trends over time by history of coronavirus disease 2019 (COVID-19) and vaccine type. Time-to-event analyses examined the outcome of loss of seroresponse (anti-spike IgG <1 Index or development of COVID-19). Cox regression adjusted for additional clinical characteristics.

Results

Among 1870 patients receiving maintenance dialysis, 1569 had no prior COVID-19. Patients without prior COVID-19 had declining titers over time. Among 443 recipients of BNT162b2 (Pfizer), median (interquartile range) anti-spike IgG titer declined from ≥20 (5.89 to ≥20) in month 1 after full vaccination to 1.96 (0.60–5.88) by month 6. Among 778 recipients of mRNA-1273 (Moderna), anti-spike IgG titer declined from ≥20 (interquartile range, ≥20 to ≥20) in month 1 to 7.99 (2.61 to ≥20) by month 6. The 348 recipients of Ad26.COV2.S (Janssen) had a lower titer response than recipients of an mRNA vaccine over all time periods. In time-to-event analyses, recipients of Ad26.COV2.S and mRNA-1273 had the shortest and longest time to loss of seroresponse, respectively. The maximum titer reached in the first 2 months after full vaccination was associated with durability of the anti-spike IgG seroresponse; patients with anti-spike IgG titer 1–19.99 had a shorter time to loss of seroresponse compared with patients with anti-spike IgG titer ≥20 (hazard ratio, 15.5; 95% confidence interval, 11.7 to 20.7).

Conclusions

Among patients receiving maintenance dialysis, vaccine-induced seroresponse wanes over time across vaccine types. Early titers after full vaccination are associated with the durability of seroresponse.

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  1. Version published to 10.2215/cjn.12250921
  2. ScreenIT

    SciScore for 10.1101/2021.09.13.21263535: (What is this?)

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

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.

    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:
    We acknowledge this study’s limitations. As with all observational studies, confounding variables may affect interpretation of results. In particular, data for months 5 and 6 primarily reflect patients who received their doses vaccine early (e.g. January and February of 2021) with a moderately higher proportion of BNT162b2/Pfizer vaccine recipients, and these patients may be frailer at baseline. In addition, we did not correlate antibody titers with breakthrough infection, an issue which remains complex and controversial. In conclusion, immunity to SARS-CoV-2 vaccines, as indicated by SAb-IgG titers, wanes over time in maintenance dialysis patients without a prior history of COVID-19. In the setting of SARS-CoV-2 variants of concern, the impact of waning titers on breakthrough infections needs to be monitored closely. The current CDC recommendation to provide a third vaccine dose based on clinical assessment for immune compromise is an important consideration for the maintenance dialysis population. A large proportion of maintenance dialysis patients have suboptimal response to the currently recommended vaccine regimens. Therefore, additional doses of vaccine should be considered for this vulnerable population, whether routinely or, with further investigation, potentially guided by protective correlates such as antibody response.

    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.
    • Thank you for including a protocol registration statement.

    Results from scite Reference Check: We found no unreliable references.

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  3. Version published to 10.1101/2021.09.13.21263535v1 on medRxiv