Immune responses following 3rd and 4th doses of heterologous and homologous COVID-19 vaccines in kidney transplant recipients

  1. Tina Thomson
  2. Maria Prendecki
  3. Sarah Gleeson
  4. Paul Martin
  5. Katrina Spensley
  6. Rute Cardoso De Aguiar
  7. Bynvant Sandhu
  8. Charlotte Seneschall
  9. Jaslyn Gan
  10. Candice L. Clarke
  11. Shanice Lewis
  12. Graham Pickard
  13. David Thomas
  14. Stephen P. McAdoo
  15. Liz Lightstone
  16. Alison Cox
  17. Peter Kelleher
  18. Michelle Willicombe

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Abstract

No abstract available

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  1. Version published to 10.1016/j.eclinm.2022.101642
  2. ScreenIT

    SciScore for 10.1101/2022.04.29.22274396: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The study ‘The effect of COVID-19 on Renal and Immunosuppressed patients’, sponsored by Imperial College London, was approved by the Health Research Authority, Research Ethics Committee (Reference: 20/WA/0123)
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Serological testing: Serum was tested for antibodies to nucleocapsid protein (anti-NP) using the Abbott Architect SARS-CoV-2 IgG 2 step chemiluminescent immunoassay (CMIA) according to manufacturer’s instructions.
    anti-NP
    suggested: None
    Spike protein antibodies (anti-S IgG) were detected using the Abbott Architect SARS-CoV-2 IgG Quant II CMIA.
    anti-S IgG
    suggested: None
    Anti-S antibody titres are quantitative with a threshold value for positivity of 7.1 BAU/ml, to a maximum value of 5680 BAU/ml.
    Anti-S
    suggested: None
    Prior to December 2021, prior infection was determined by the presence of anti-NP or receptor binding domain (RBD) antibodies, using an in-house double binding antigen ELISA (Imperial Hybrid DABA; Imperial College London, London, UK), which detects total RBD antibodies.
    anti-NP or receptor binding domain ( RBD )
    suggested: None
    in-house double binding antigen ELISA
    suggested: None
    Software and Algorithms
    SentencesResources
    Serological testing: Serum was tested for antibodies to nucleocapsid protein (anti-NP) using the Abbott Architect SARS-CoV-2 IgG 2 step chemiluminescent immunoassay (CMIA) according to manufacturer’s instructions.
    Abbott Architect
    suggested: (Abbott ARCHITECT i1000sr System, RRID:SCR_019328)
    Statistical Analysis: Statistical analysis was conducted using Prism 9.3.1 (GraphPad Software Inc.
    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:
    Technical limitations of the study include reliance on an ELISpot assay which assesses IFN-γ as the sole read out for T-cell reactivity, rather than poly-functional cytokine responses, and lack of data on antibody neutralising capabilities10,11. Consistent with this immunogenicity data, real world vaccine efficacy has been shown to be inferior in immunocompromised people, who have been at highest risk of breakthrough infections and severe disease, in the pre-Omicron era12-14. So, what does this mean for the strategic forward planning to protect transplant recipients? The data shown in this study suggest that a proportion of transplant recipients who have not responded to the first 4 vaccines, are unlikely to develop meaningful protection with a fifth. Whilst for other immunocompromised people, mostly those on B-cell directed therapies, robust SARS-CoV-2 T-cell responses have been demonstrated in the absence of antibodies, for solid organ transplant patients who are commonly maintained on both B-cell and T-cell inhibiting agents, this will not necessarily be the case3,15. With treatment options also limited in this group, related to relative contraindications and drug interactions, pre-exposure prophylaxis with passive immunity from neutralising monoclonal antibodies may currently be the best option whilst they remain effective against the current dominant variant16. In summary, we have shown that repeated vaccinations will not adequately protect all transplant recipients. How...

    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 10.1101/2022.04.29.22274396v1 on medRxiv