Efficacy of Severe Acute Respiratory Syndrome Coronavirus-2 Vaccine in Patients With Thoracic Cancer: A Prospective Study Supporting a Third Dose in Patients With Minimal Serologic Response After Two Vaccine Doses

  1. Valérie Gounant
  2. Valentine Marie Ferré
  3. Ghassen Soussi
  4. Charlotte Charpentier
  5. Héloïse Flament
  6. Nadhira Fidouh
  7. Gilles Collin
  8. Céline Namour
  9. Sandra Assoun
  10. Alexandra Bizot
  11. Zohra Brouk
  12. Eric Vicaut
  13. Luis Teixeira
  14. Diane Descamps
  15. Gérard Zalcman

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Abstract

No abstract available

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  1. Version published to 10.1016/j.jtho.2021.10.015
  2. ScreenIT

    SciScore for 10.1101/2021.08.12.21261806: (What is this?)

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

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    BlindingSample processing and data analyses were performed, with all study personal blinded to information concerning patients and samples.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    To set up the technical conditions for SARS-CoV-2 anti-nucleocapsid (N) index and anti-Spike antibody determination, 18 control subjects from Hôpital Bichat staff, without previous COVID-19 symptoms or PCR-proved SARS-CoV-2 infection, provided their written consent for blood sampling.
    anti-nucleocapsid ( N
    suggested: None
    anti-Spike
    suggested: (GeneTex Cat# GTX632604, RRID:AB_2864418)
    Laboratory analyses: SARS-CoV-2 anti-N and anti-S antibody titers were determined using Abbott Architect SARS-CoV-2 IgG and IgG Quant II (Abbott, Maidenhead, UK) and expressed as index (cut-off: 0.49) and arbitrary units (cut-off: 50 AU/mL), respectively.
    SARS-CoV-2
    suggested: None
    anti-N
    suggested: None
    anti-S
    suggested: None
    Pseudo-neutralization assay was performed using iFlash-2019-nCoV Nab assay (YHLO, Shenzhen, China), which assesses antibody neutralizing capacity by competition with angiotensin-converting enzyme 2 (ACE2)-receptor for binding to anti-spike RBD (cut-off: 10AU/mL).
    anti-spike RBD
    suggested: None
    Software and Algorithms
    SentencesResources
    Laboratory analyses: SARS-CoV-2 anti-N and anti-S antibody titers were determined using Abbott Architect SARS-CoV-2 IgG and IgG Quant II (Abbott, Maidenhead, UK) and expressed as index (cut-off: 0.49) and arbitrary units (cut-off: 50 AU/mL), respectively.
    Abbott Architect
    suggested: (Abbott ARCHITECT i1000sr System, RRID:SCR_019328)
    Abbott
    suggested: (Abbott, RRID:SCR_010477)
    De-identified data were exported from Microsoft Excel Version 2013 for Windows
    Microsoft Excel
    suggested: (Microsoft Excel, RRID:SCR_016137)

    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:
    A possible limitation to such outcome is the decrease in SARS-CoV-2 virus circulation <0.79 in France by mid-May 2021, versus 1.2 or 1.3 in late January 2021. However, a dramatic rise in infections occurred early July, resulting in >20,000 new daily cases. The patient acceptation rate of systematic vaccination was in line with previous reports, with only 11% initial refusals29. Reactogenicity was weak, without short-term serious adverse effects in this real-life setting. We did not observe specific safety concerns in ICI-treated patients, especially regarding immune-related side-effects, as reported by Israeli teams30. Moreover, our study emphasized that sero-conversion monitoring could be useful in immuno-suppressed patients. In this population, the first vaccine efficacy was much lower than that reported in vaccine registration trials, with one-third of patients displaying negative serological testing (≤50 AU/mL) at Day 28, whereas three-quarters exhibited <25 percentile serological titer distribution. These data are in line with prospective studies involving a mixed population with solid cancers and hematological malignancies31, 32. Although there has been no clear cut-off for antibody titers predicting protection against severe COVID-19, a 300 AU/mL cut-off was shown to well correlate with the pseudo-neutralization assay, as a readout for anti-viral efficacy. We thus selected this value as protection cut-off against SARS-CoV-2 infection in our patients33. Let us keep in m...

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04776005Not yet recruitingCOVID-19 Vaccine Efficacy in Patients With Malignant Patholo…

    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 10.1101/2021.08.12.21261806v1 on medRxiv