Effect of Immunosuppression on the Immunogenicity of mRNA Vaccines to SARS-CoV-2

  1. Parakkal Deepak
  2. Wooseob Kim
  3. Michael A. Paley
  4. Monica Yang
  5. Alexander B. Carvidi
  6. Emanuel G. Demissie
  7. Alia A. El-Qunni
  8. Alem Haile
  9. Katherine Huang
  10. Baylee Kinnett
  11. Mariel J. Liebeskind
  12. Zhuoming Liu
  13. Lily E. McMorrow
  14. Diana Paez
  15. Niti Pawar
  16. Dana C. Perantie
  17. Rebecca E. Schriefer
  18. Shannon E. Sides
  19. Mahima Thapa
  20. Maté Gergely
  21. Suha Abushamma
  22. Sewuese Akuse
  23. Michael Klebert
  24. Lynne Mitchell
  25. Darren Nix
  26. Jonathan Graf
  27. Kimberly E. Taylor
  28. Salim Chahin
  29. Matthew A. Ciorba
  30. Patricia Katz
  31. Mehrdad Matloubian
  32. Jane A. O’Halloran
  33. Rachel M. Presti
  34. Gregory F. Wu
  35. Sean P.J. Whelan
  36. William J. Buchser
  37. Lianne S. Gensler
  38. Mary C. Nakamura
  39. Ali H. Ellebedy
  40. Alfred H.J. Kim

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Abstract

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  1. Version published to 10.7326/m21-1757
  2. ScreenIT

    SciScore for 10.1101/2021.04.05.21254656: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: All participants provided written informed consent.
    IRB: Ethics approval: This study was approved by the Washington University School of Medicine Institutional Review Board (protocol #201105110, approved 6/1/2011; protocol #202012081, approved 12/21/2020; and protocol #202012084, approved 12/23/2020) and the UCSF Institutional Review Board (protocol #17-21898, approved 4/22/2017 and protocol #20-33078, approved 1/4/2021).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    The initial phase of COVaRiPAD specifically examined the magnitude and quality of the acute humoral response.
    COVaRiPAD
    suggested: None
    Patient recruitment: 133 participants with confirmed CID and 53 immunocompetent controls recruited from the faculty, employees, staff, and patients at Washington University School of Medicine and BJC Healthcare system (St. Louis, MO, USA) and the University of California, San Francisco, UCSF Health, and Zuckerberg San Francisco General Hospital (San Francisco, CA, USA) from 12/10/2020 to 3/20/2021.
    BJC Healthcare
    suggested: None
    Statistical analysis: Statistical analyses were performed using Prism v9.1.0 (GraphPad Software) and Stata/MP 13.1.
    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:
    The limitations of the study include small sample sizes for several classes of immunosuppressives (i.e. anti-IL-17, belimumab, abatacept), preventing any analysis. Additionally, we cannot evaluate differences between the two mRNA vaccines, nor with the adenovirus delivery platform. We also have limited racial and ethnic diversity due to selection bias (most subjects are faculty/staff at academic teaching hospitals). We have continued recruitment to address this. We will report safety, reactogenicity, disease state, and changes in disease activity in future studies. Assessing long-term responses (i.e. 6 months post-booster) and neutralization of variants of concern will be critical as the impact of immunosuppression on vaccine response durability and epitope breadth is unknown. Most immunocompetent subjects vaccinated with mRNA-1273 only had modest reductions in neutralization 3 months post-booster,38 while recovered COVID-19 patients, maintained antibody, B, and T cell responses up to 8 months after infection.39 Of concern though, is the poor neutralization responses to B.1.351 in previously uninfected immunocompetent subjects following mRNA vaccination.40 Whether immunosuppression may further attenuate cross-variant neutralization is unclear. In summary, this initial analysis of the COVaRiPAD study, focusing on the magnitude and quality of antibody responses after two doses of either BNT162b2 or mRNA-1273, reveals that most patients with CID on immunosuppressive treatment we...

    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.

    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 10.1101/2021.04.05.21254656v2 on medRxiv
  4. Version published to 10.1101/2021.04.05.21254656v1 on medRxiv