SARS-CoV-2 vaccine effectiveness and breakthrough infections in maintenance dialysis patients

  1. Harold J. Manley
  2. Gideon N. Aweh
  3. Caroline M. Hsu
  4. Daniel E. Weiner
  5. Dana Miskulin
  6. Antonia M. Harford
  7. Doug Johnson
  8. Eduardo K. Lacson

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Abstract

Background

SARS-CoV-2 vaccine effectiveness during the Delta period and immunogenicity threshold associated with protection against COVID-19 related hospitalization or death in the dialysis population is unknown.

Methods

A retrospective, observational study assessed SARS-CoV-2 vaccine effectiveness and immunogenicity threshold in all adult maintenance dialysis patients without COVID-19 history treated between February 1 and October 2, 2021. All COVID-19 infections, composite of hospitalization or death following COVID-19 and available SARS-CoV-2 anti-spike immunoglobulin (Ig) G values were extracted from electronic medical record. COVID-19 cases per 10,000 days at risk and vaccine effectiveness during pre-Delta and Delta periods were determined.

Results

Of 15,718 patients receiving dialysis during the study period, 11,191 (71%) were fully vaccinated, 733 (5%) were partially vaccinated and 3,794 (24%) were unvaccinated. 967 COVID-19 were cases identified: 511 (53%) occurred in unvaccinated patients and 579 (60%) occurred during the Delta period. COVID-19 related hospitalization or death was less likely among vaccinated versus unvaccinated patients for all vaccines (adjusted HR 0.19 [0.12, 0.30]) and for BNT162b2/Pfizer, mRNA-1273/Moderna, and Ad26.COV2.S/Janssen (adjusted HR=0.25 [0.16, 0.40], 0.14 [0.08, 0.22], and 0.34 [0.17, 0.68] respectively). Among those with anti-spike IgG levels, those with IgG level ≥ 7 had significantly lower risk of a COVID-19 diagnosis (HR=0.25 [0.15, 0.42]) and none experienced a COVID-related hospitalization or death.

Conclusions

Among maintenance dialysis patients, SARS-CoV-2 vaccination was associated with a lower risk of COVID-19 diagnosis and associated hospitalization or death. Among vaccinated patients, low anti-spike IgG level is associated with worse COVID-19 related outcomes.

Significance Statement

SARS-CoV-2 vaccine effectiveness and association between antibody levels and clinical outcomes in maintenance dialysis patients is not known. Between February 1 and October 2, 2021, vaccine effectiveness was 85% against COVID-19 infection and 81% against composite of COVID-related hospitalization or death. COVID-19 case rates and severe outcomes were higher during the Delta dominant period (June 27-October 2, 2021). Increasing time (weeks) since full vaccination status was associated with increased risk for COVID-19 related hospitalization or death. Anti-spike IgG level ≥ 7 had lower risk of a COVID-19 diagnosis and no COVID-related hospitalization or death. Our findings supports utilization of SARS-CoV-2 vaccination and suggests that monitoring SARS-CoV-2 antibody levels and administering additional vaccine doses to maintain adequate immunity will be beneficial.

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  1. ScreenIT

    SciScore for 10.1101/2021.12.20.21268124: (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

    Antibodies
    SentencesResources
    SARS-CoV-2 Antibody Testing: The DCI central laboratory assesses serum anti-spike IgG antibody against the receptor binding domain of the S1 subunit of SARS-CoV-2 spike antigen using a US-FDA-EUA-approved chemiluminescent assay (ADVIA Centaur® XP/XPT COV2G).
    anti-spike IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    These variables include: SARS-CoV-2 vaccine name and dates administered, age, sex, race (Black, White, Native American, Asian/Pacific Islander, Other/Unknown), ethnicity (Hispanic or Non-Hispanic), US state and county of residence, congregate living status (e.g., nursing home, long term care facility), modality (in-center hemodialysis, home hemodialysis, peritoneal dialysis), date of ESRD, body mass index, dialysis dose delivered (Kt/V), serum albumin, hepatitis B surface antibody, immunosuppression (immune-modulating medications, prior transplant, immunodeficiency disorder), substance abuse disorder (tobacco, alcohol or drug), and other comorbid conditions.
    Islander
    suggested: (Islander, RRID:SCR_007758)
    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:
    However, there are limitations associated with this study. Due to the observational design, residual biases (e.g., misclassification of vaccine exposure in patients vaccinated outside the clinic, inability to identify all asymptomatic infections) and confounding may exist. Randomized clinical trials comparing individual COVID-19 vaccines head-to-head are not likely to be performed in this population. The electronic health records do not contain standardized documentation of COVID-19 symptoms and therefore we could not estimate vaccine effectiveness with regard to mitigating or tempering severity of symptoms. Although the model adjusted for likelihood to follow mask, social distancing and vaccine recommendations throughout the US by adjusting for state and county level presidential election voting records, individual patient actual adherence to those recommendations is not known. Finally, we did not know the specific SARS-CoV-2 variant for each infection and attributed all infections to the Delta variant after June 26, 2021. In conclusion, SARS-CoV-2 vaccines are effective in maintenance dialysis patients, reducing the risk of both COVID-19 cases and COVID-related hospitalization or death. COVID-19 cases increased during the Delta variant dominant period and current immunosuppression criteria are limited in identifying dialysis patients at highest breakthrough risk. Further research is needed to evaluate the potential utility of antibody titer monitoring to determine patients ...

    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

    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.

  2. Version published to 10.1101/2021.12.20.21268124 on medRxiv