BNT162B2 mRNA COVID-19 Vaccine in Heart and Lung Transplanted Young Adults: Is an Alternative SARS-CoV-2 Immune Response Surveillance Needed?

  1. Nicola Cotugno
  2. Chiara Pighi
  3. Elena Morrocchi
  4. Alessandra Ruggiero
  5. Donato Amodio
  6. Chiara Medri
  7. Luna Colagrossi
  8. Cristina Russo
  9. Silvia Di Cesare
  10. Veronica Santilli
  11. Emma Concetta Manno
  12. Paola Zangari
  13. Carmela Giancotta
  14. Stefania Bernardi
  15. Luciana Nicolosi
  16. Marta Ciofi Degli Atti
  17. Massimiliano Raponi
  18. Salvatore Zaffina
  19. Sara Alfieri
  20. Richard Kirk
  21. Carlo Federico Perno
  22. Paolo Rossi
  23. Antonio Amodeo
  24. Paolo Palma

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Abstract

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  1. Version published to 10.1097/tp.0000000000003999
  2. ScreenIT

    SciScore for 10.1101/2021.09.20.21263836: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: All procedures performed in the study were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments.
    Consent: Local ethical committee approved the study and written informed consent was obtained from all participants or legal guardians.
    Field Sample Permit: Sample collection and storage: Venous blood was collected in EDTA tubes and processed within 2 hours.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Humoral response: Anti-SARS Cov-2 IgG Antibodies (Ab) titres were measures as previously described13 at T0, T21 and T28 and during the follow up visits at approximetly 120 days after the 1st dose (T120).
    Anti-SARS Cov-2 IgG
    suggested: None
    Surface staining was performed using the following antibodies: CD3 PE-CF594 (clone UCHT1, BD (562280)), CD4 APC-Cy7 (clone RPA-T4, BD (557871)), CD27 FITC (clone M-T271, BD (555440)), CD45RO PE-Cy5 (clone UCHL1, BD), CD185 BV605 (CXCR5, clone RF8B2, BS), CD10 BV510 (clone HI10a, BD 563032), CD19 APC-R700 (clone SJ25C1, BD 659121), CD21 APC (clone B-Ly4, BD 559867), IgD BV421 (clone IA6-2, BD 565940).
    CXCR5
    suggested: (BD Biosciences Cat# 563105, RRID:AB_2738008)
    CD10
    suggested: (BD Biosciences Cat# 563032, RRID:AB_2737964)
    CD19
    suggested: (BD Biosciences Cat# 659121, RRID:AB_2870470)
    CD21 APC
    suggested: (BD Biosciences Cat# 559867, RRID:AB_2085309)

    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:
    This study presents some limitations mainly due to the small sample size, the short time of follow up and the absence of adequately represented groups of distinct immune suppressive regimens. Larger studies are needed in order to identify a) the proper timing of vaccination to elicit protective immune responses, b) informative correlates of protection and c) alternative immunization strategies for those patients who did not mount protective immune responses upon mRNA vaccine.

    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: Please consider improving the rainbow (“jet”) colormap(s) used on pages 27 and 28. At least one figure is not accessible to readers with colorblindness and/or is not true to the data, i.e. not perceptually uniform.

    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 10.1101/2021.09.20.21263836v1 on medRxiv