SARS-CoV-2 Vaccine Antibody Response and Breakthrough Infection in Patients Receiving Dialysis

This article has been Reviewed by the following groups

Read the full article See related articles

Abstract

No abstract available

Article activity feed

  1. SciScore for 10.1101/2021.10.12.21264860: (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 requirement for consent.
    Sex as a biological variablenot detected.
    RandomizationFrom among the 17,390 seronegative patients, we used systematic sampling with fraction intervals15 stratified by age to randomly select 4,346 persons to follow with monthly SARS-CoV-2 serology assays (see Supplemental Methods for sample size).
    Blindingnot detected.
    Power Analysisnot detected.
    Cell Line AuthenticationAuthentication: The assay is reported by the manufacturer to have 100% sensitivity and 99.8% specificity if performed ≥14 days after a positive reverse transcriptase polymerase chain reaction test (RT-PCR)17; it has been validated independently with similar performance characteristics18,19.

    Table 2: Resources

    Antibodies
    SentencesResources
    We ascertained effect modification by separately adding to the quantile regression model the interaction between time window and RBD antibody status prior to vaccination, vaccine type, age, and diabetes status.
    RBD
    suggested: None
    Software and Algorithms
    SentencesResources
    In partnership with Ascend Clinical, a central laboratory processing routine monthly laboratory tests of persons receiving dialysis at several dialysis networks including US Renal Care, we tested these samples for RBD antibody, and ascertained patient characteristics, vaccination status, and COVID-19 diagnoses using electronic health records.
    Ascend
    suggested: (ascend, RRID:SCR_017257)

    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:
    The limitations of our work include the reliance on RBD as the single measure of antibody response, and use of the electronic health records to detect cases. Although pragmatic and likely detecting clinically meaningful events, this strategy misses asymptomatic cases and those with minor symptoms. Vaccine types were not randomly allocated and the number of patients who received Ad26.CoV2.S was low; therefore, comparisons of response by vaccine type should be interpreted with caution. The number of breakthrough infections was relatively small, but was proportionately higher than in healthy cohorts, and in absolute numbers equivalent to or higher than those described from clinical trials11,12. Furthermore, the observed associations despite the modest sample size and number of events highlights the relevance of our findings. Finally recommended immunization schedules are changing, with an additional (third) dose of BNT162b2 now added for select groups in the US, and our study does not evaluate response to these third doses. In summary, among patients receiving dialysis, the humoral response to SARS-CoV-2 vaccination wanes and is associated with risk for breakthrough infection. Serologic testing using commercially available high-throughput assays could inform vaccination and enhanced mitigation strategies in immunocompromised and other high-risk populations. Even as new vaccine platforms and immunization schedules are employed, further research investigating the associations betw...

    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.