Dynamics of antibody titers and cellular immunity among Japanese healthcare workers during the 6 months after receiving two doses of BNT162b2 mRNA vaccine

  1. Yoshifumi Uwamino
  2. Toshinobu Kurafuji
  3. Kumiko Takato
  4. Akiko Sakai
  5. Akiko Tanabe
  6. Masayo Noguchi
  7. Yoko Yatabe
  8. Tomoko Arai
  9. Akemi Ohno
  10. Yukari Tomita
  11. Ayako Shibata
  12. Hiromitsu Yokota
  13. Wakako Yamasawa
  14. Ho Namkoong
  15. Yasunori Sato
  16. Naoki Hasegawa
  17. Masatoshi Wakui
  18. Mitsuru Murata

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Abstract

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  1. Version published to 10.1016/j.vaccine.2022.06.016
  2. ScreenIT

    SciScore for 10.1101/2022.01.29.22270052: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: Written informed consent was obtained from all participants before mass vaccination.
    IRB: The study was approved by the ethics committee of the Keio University School of Medicine (approval no. 20200330).
    Field Sample Permit: Based on the limited reagents supply, only the first 600 participants were selected at the time of the first sample collection, and whole blood samples were collected in lithium heparin tubes at the first, third, and final sampling points.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Measurement of antibody titres: Antibody titres to SARS-CoV-2 spike protein (S-IgG) and neutralising antibody titres of all collected serum samples were measured using three commercially available chemiluminescence enzyme immunoassay (CLEIA) methodology-based reagents.
    SARS-CoV-2 spike protein ( S-IgG
    suggested: None
    First, IgG antibody titres against the SARS-CoV-2 spike protein S1 subunit receptor-binding domain (RBD) were measured using SARS-CoV-2 IgG II Quant reagents(Abbott Laboratories, Abbott Park, IL, USA) and an Alinity Analyzer (Abbott Laboratories, Abbott Park, IL, USA) according to the manufacturer’s instructions (Alinity RBD-IgG).
    IgG
    suggested: None
    SARS-CoV-2 spike protein S1 subunit receptor-binding domain ( RBD
    suggested: None
    SARS-CoV-2 IgG
    suggested: None
    Second, the IgG antibody titres against the anti-SARS-CoV-2 spike protein were measured using other chemiluminescence enzyme immunoassay (CLEIA) methodology-based systems and reagents: HISCL Analyzer (Sysmex Corporation, Kobe, Japan) and HISCL SARS-CoV-2
    anti-SARS-CoV-2 spike protein
    suggested: None
    For measuring the immunoglobulin G (IgG) antibody titre against the nucleocapsid protein (N-IgG), we used the HISCL Analyzer (Sysmex Corporation, Kobe, Japan) and HISCL SARS-CoV-2
    immunoglobulin G ( IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    Participants: Healthcare workers working on the Keio University Shinanomachi Campus (Tokyo, Japan) who were vaccinated against SARS-CoV-2 between 16 February and 9 March, 2021 were recruited for the study.
    Participants: Healthcare
    suggested: None
    First, IgG antibody titres against the SARS-CoV-2 spike protein S1 subunit receptor-binding domain (RBD) were measured using SARS-CoV-2 IgG II Quant reagents(Abbott Laboratories, Abbott Park, IL, USA) and an Alinity Analyzer (Abbott Laboratories, Abbott Park, IL, USA) according to the manufacturer’s instructions (Alinity RBD-IgG).
    Abbott Laboratories
    suggested: None
    All statistical analyses were performed using JMP, version 15 and SAS software, version 9.4 (SAS Institute, Cary, NC, USA).
    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:
    This study had several limitations. First, STACIA Neut-Ab, which was used as the neutralisation assay, could only detect the antibody activity to inhibit RBD binding to human ACE 2. Although the STACIA Neut-Ab results for monoclonal antibodies correlated well with the neutralisation assay results using in vitro SARS-CoV-2 infection in cells, neutralisation is thought to incompletely represent in vivo humoral immunity against SARS-CoV-2 with polyclonality [14]. Therefore, the verification of neutralising antibody using SARS-CoV-2 infected cells or animals is ideal. Second, cross-reactivity of the N-IgG antibody test has been reported. False positive results might be obtained due to cross-reactivity to coronavirus NL63 and 229E infections; therefore, N-IgG-positive conversion do not always signify breakthrough SARS-CoV-2 infection. However, the occurrence of NL63 and 229E infections cannot explain the elevation of HISCL S-IgG titres after 6 months of vaccination because of the specificity of the measured antibody to SARS-CoV-2 infections [15]. Third, the incidence of breakthrough infections could not be explained simply by waning humoral and cellular immunity. Occupational contact with COVID-19 patients, social activity, and prevalence of SARS-CoV-2 infection may have affected the results. Especially, between the fourth to fifth sample collection time-points, there was a high incidence of SARS-CoV-2 recorded in Japan during the Olympic and Paralympic games in Tokyo. Therefore, ...

    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 10.1101/2022.01.29.22270052 on medRxiv