Cellular and humoral immunogenicity of a SARS-CoV-2 mRNA vaccine in patients on haemodialysis

  1. Monika Strengert
  2. Matthias Becker
  3. Gema Morillas Ramos
  4. Alex Dulovic
  5. Jens Gruber
  6. Jennifer Juengling
  7. Karsten Lürken
  8. Andrea Beigel
  9. Eike Wrenger
  10. Gerhard Lonnemann
  11. Anne Cossmann
  12. Metodi V. Stankov
  13. Alexandra Dopfer-Jablonka
  14. Philipp D. Kaiser
  15. Bjoern Traenkle
  16. Ulrich Rothbauer
  17. Gérard Krause
  18. Nicole Schneiderhan-Marra
  19. Georg M.N. Behrens

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Abstract

No abstract available

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  3. Version published to 10.1016/j.ebiom.2021.103524
  4. ScreenIT

    SciScore for 10.1101/2021.05.26.21257860: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: 2.1 Study design and sample collection: Following written informed consent, heparinized blood samples from hemodialysis patients were taken before start of dialysis using the vascular access which was either an arterio-venous fistula or a central venous catheter or by venipuncture from health care workers (control).
    IRB: 2.2 Ethics statement: The study was approved by the Internal Review Board of Hannover Medical School (MHH, approval number 8973_BO-K_2020).
    Field Sample Permit: 2.10 Role of the funders: This work was financially supported by the Initiative and Networking Fund of the Helmholtz Association of German Research Centers (grant number SO-96), the EU Horizon 2020 research and innovation program (grant agreement number 101003480 - CORESMA) and the State Ministry of Baden-Württemberg for Economic Affairs, Labor and Tourism (grant numbers FKZ 3-4332.62-NMI-67 and FKZ 3-4332.62-NMI-68).
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    As subsequent antibody testing was negative for SARS-CoV-2 IgG, this patient received BNT162b2 and was not excluded from our study.
    SARS-CoV-2 IgG
    suggested: None
    Bound antibodies were detected following a 45 min incubation at 21°C with R-phycoerythrin labeled goat-anti-human IgG (Jackson ImmunoResearch Labs, United Kingdom, Cat# 109-116-098, Lot# 148837, RRID: AB_2337678, used at 3 µg/mL) or IgA (Jackson ImmunoResearch Labs, Cat# 109-115-011, Lot# 143454, RRID: AB_2337674, used at 5 µg/mL) as secondary antibodies.
    R-phycoerythrin labeled goat-anti-human IgG
    detected: (Jackson ImmunoResearch Labs Cat# 109-115-011, RRID:AB_2337674)
    R-phycoerythrin
    detected: (Jackson ImmunoResearch Labs Cat# 109-116-098, RRID:AB_2337678)
    Software and Algorithms
    SentencesResources
    Figures were exported from Rstudio and then edited using Inkscape (Inkscape 0.92.4).
    Rstudio
    suggested: (RStudio, RRID:SCR_000432)
    Inkscape
    suggested: (Inkscape, RRID:SCR_014479)
    Pre-processing of data such as matching sample metadata and collecting results from multiple assay platforms was performed in Excel 2016.
    Excel
    suggested: None

    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:
    Our study has several limitations. While we have a reasonable sample size (81 dialysis patients), which is similar or even larger compared to several other studies (12, 13, 25), our control group is not age- and gender-matched. In addition, we evaluated only one of the currently approved SARS-CoV-2 vaccines with samples from a single dialysis center and did not perform in-depth immune phenotyping or assessment of SARS-CoV-2 responsive T-cell frequencies. We also lack paired saliva and plasma samples pre- and post first dose to characterize B- and T-cell response kinetics or assess potential cross-reactivity of endemic CoV antibodies in immunocompromised individuals across the dosing scheme. However, all of our samples were collected at the same time and following an identical dosing regimen, allowing us to make a direct comparison between our two groups of interest (dialyzed versus non-dialyzed). Additionally, the lack of previously infected samples within our study groups, means we are studying only the vaccine-induced response. Taken together, we provide robust evidence that a completed two-dose regimen of BNT162b2 elicits both antibody and T-cell responses in patients on maintenance dialysis towards the SARS-CoV-2 B.1 isolate. Future studies are needed to assess the lifespan and long-term kinetics of the vaccination response. As neutralization is reduced in dialyzed patients towards all VoCs examined, our data also highlights the need to monitor if infection with SARS-CoV-...

    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.

  5. Version published to 10.1101/2021.05.26.21257860v1 on medRxiv