Dynamics of anti-Spike IgG antibody level after the second BNT162b2 COVID-19 vaccination in health care workers

  1. Hiroaki Ikezaki
  2. Hideyuki Nomura
  3. Nobuyuki Shimono

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Abstract

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  1. Version published to 10.1016/j.jiac.2022.02.024
  2. ScreenIT

    SciScore for 10.1101/2021.12.14.21267783: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: All participants provided written informed consent prior to enrollment.
    IRB: All studies were carried out in accordance with the principles of the Declaration of Helsinki, as revised in 2008, and approved by the Haradoi hospital institutional ethics review committee prior to data collection (Approval No. 2020-08).
    Sex as a biological variableBecause most of the study participants were nurses, approximately 80% of the participants were women.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    This study consisted of two sub-studies: the first was to evaluate the dynamics of anti-spike IgG levels by measuring IgG antibody levels before the first vaccination, three weeks after the first vaccination (just before the second vaccination), and one month, two months, four months, and six months after the second vaccination; included 49 participants in the first sub-study (Analysis-1).
    anti-spike IgG levels by measuring IgG
    suggested: None
    Analysis-1
    suggested: None
    The second was to evaluate IgG antibody levels six months after the second vaccination, and 373 participants, including above 49 Analysis-1 participants, participated in the second sub-study (Analysis-2).
    Analysis-2
    suggested: None
    We performed additional IgG / IgM antibody qualitative tests against SARS-CoV-2 nucleocapsid protein for participants whose anti-spike IgG antibodies were in the top 10% (2100 AU/ml) in Analysis-2 participants.
    SARS-CoV-2 nucleocapsid protein
    suggested: None
    anti-spike IgG
    suggested: None
    The other three were positive for IgG / IgM antibody against nucleocapsid protein.
    antibody against nucleocapsid protein.
    suggested: None
    Additional qualitative testing for IgG and IgM antibodies against nucleocapsid protein was performed using the SARS-CoV-2 IgG and IgM assays (Abbott Diagnostics).
    SARS-CoV-2 IgG
    suggested: None
    The results of anti-nucleocapsid IgG and IgM antibodies are expressed as index (S/C) (positive thresholds: 1.40 index [S/C] for IgG and 1.00 index [S/C] for IgM).
    anti-nucleocapsid IgG
    suggested: None
    IgM
    suggested: None
    Software and Algorithms
    SentencesResources
    measurement: Levels of anti-spike IgG were quantified using the SARS-CoV-2 IgG II Quant assay (Abbott Diagnostics, Chicago, IL, USA).
    Abbott
    suggested: (Abbott, RRID:SCR_010477)
    Statistical analysis: All analyses were performed using SAS version 7.4 (SAS Institute Inc).
    SAS Institute
    suggested: (Statistical Analysis System, RRID:SCR_008567)

    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:
    Some limitations of this study should be noted. We only assessed anti-spike IgG levels, lacking neutralizing antibodies and cellular immunity, which prevent severe disease. The sample size of the whole cohort was small and only 10% of the participants were over 60 years old. In addition, most of the participants did not have any comorbidities. Further extensive studies including participants with various backgrounds and assessing the neutralizing antibodies and cellular immunity are necessary.

    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 10.1101/2021.12.14.21267783 on medRxiv