Comparison of immunogenicity and clinical effectiveness between BNT162b2 and ChAdOx1 SARS-CoV-2 vaccines in people with end-stage kidney disease receiving haemodialysis: A prospective, observational cohort study

  1. Paul Martin
  2. Sarah Gleeson
  3. Candice L. Clarke
  4. Tina Thomson
  5. Helena Edwards
  6. Katrina Spensley
  7. Paige Mortimer
  8. Stacey McIntyre
  9. Alison Cox
  10. Graham Pickard
  11. Liz Lightstone
  12. David Thomas
  13. Stephen P. McAdoo
  14. Peter Kelleher
  15. Maria Prendecki
  16. Michelle Willicombe

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Abstract

No abstract available

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  1. Version published to 10.1016/j.lanepe.2022.100478
  2. ScreenIT

    SciScore for 10.1101/2021.07.09.21260089: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The study was approved by the Health Research Authority, Research Ethics Committee (Reference: 20/WA/0123 - The Impact of COVID-19 on Patients with Renal disease and Immunosuppressed Patients).
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Anti-S antibody titres are quantitative with a threshold value of 7.1 BAU/ml for positivity, and an upper level of detection of 5680 BAU/ml.
    Anti-S
    suggested: None
    As part of this protocol, patients were initially screened for anti-NP, and those with a subthreshold anti-NP index value (0.25-1.4), underwent confirmatory testing for natural infection by assessing for receptor binding domain (anti-RBD) antibodies.
    anti-NP
    suggested: None
    anti-RBD
    suggested: None
    This was performed using an in-house double binding antigen ELISA (Imperial Hybrid DABA; Imperial College London, London, UK), which detects total RBD antibodies10-13 Statistical Analysis: Statistical analysis was conducted using Prism 9.0 (GraphPad Software Inc., San Diego, California).
    in-house double binding antigen ELISA
    suggested: None
    antibodies10-13
    suggested: None
    Software and Algorithms
    SentencesResources
    These patients included participants of the OCTAVE study, an Observational Cohort Study of T-cells, Antibodies and Vaccine Efficacy in SARS-CoV-2 in people with chronic diseases and/or secondary immunodeficiency, which is part of the UK COVID-19 Immunity National Core Study Programme.
    OCTAVE
    suggested: (GNU Octave, RRID:SCR_014398)
    For vaccine responses, anti-S IgG were assessed using the Abbott Architect SARS-CoV-2 IgG Quant II CMIA.
    Abbott Architect
    suggested: (Abbott ARCHITECT i1000sr System, RRID:SCR_019328)
    Detection of cellular responses to SARS-CoV-2: SARS-CoV-2 specific T-cell responses were detected using the T-SPOT® Discovery SARS-CoV-2, and assays performed by Oxford Immunotec.
    Oxford Immunotec
    suggested: None
    This was performed using an in-house double binding antigen ELISA (Imperial Hybrid DABA; Imperial College London, London, UK), which detects total RBD antibodies10-13 Statistical Analysis: Statistical analysis was conducted using Prism 9.0 (GraphPad Software Inc., San Diego, California).
    Prism
    suggested: (PRISM, RRID:SCR_005375)
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)

    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:
    Limitations of our study include the unknown effect of the delayed prime-boost strategy of 8-12 weeks in the UK on the immunogenicity results in the patients who received BNT162b2. However, our seroconversion rates of 88.3% are comparable with other studies who report following a 3-4 week dosing interval1,2. Our control group is not matched for age, and being younger there may be an overestimate of the immune responses in healthy controls9. In addition, our control group, especially those receiving ChAdOx1, is relatively small and therefore susceptible to type II error in reporting. However, the major strength of our study is that we are the first to comprehensively report on the immunological response to the ChAdOx1 vaccine in patients with kidney disease. This is the largest analysis of both humoral and cellular responses to date in an ESKD population, and we report detailed patient level data. Moreover, our ethnically diverse cohort has been characterised in depth throughout the pandemic with regular screening via PCR and serological testing, enabling accurate identification of individuals with prior exposure13,29,30. It is important to highlight, that although we have dissected the immunogenic properties of both the BNT162b2 and ChAdOx1 vaccines to better compare their properties in a haemodialysis population, immune responses to both vaccines were encouraging in light of the recognised attenuated responses to other commonly used vaccines such as Influenza and Hepatitis B...

    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.

  3. Version published to 10.1101/2021.07.09.21260089v1 on medRxiv