Evaluation of the antibody response and adverse reactions of the BNT162b2 vaccine of participants with prior COVID-19 infection in Japan

  1. Toshiya Mitsunaga
  2. Yuhei Ohtaki
  3. Yutaka Seki
  4. Masakata Yoshioka
  5. Hiroshi Mori
  6. Midori Suzuka
  7. Syunsuke Mashiko
  8. Satoshi Takeda
  9. Kunihiro Mashiko

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Abstract

Introduction

Vaccination programs are important to preventing COVID-19 infection. BNT162b2 is new type of vaccine, and previous studies have shown that the antibody response was significantly elevated in patients with prior COVID-19 infection after the first vaccination. However, no study has evaluated the efficacy of the vaccination or the adverse reactions of people with prior COVID-19 infection in Japan. The aim of this study is to evaluate the antibody titer and adverse reactions of BNT162b2 vaccine among participants with prior COVID-19 infection in Japan.

Methods

The data for this study was collected between April 15, 2021, and June 9, 2021. All of the hospital staff who received the BNT162b2 vaccine were included in this study and were sorted into either the prior infection group or the control group. We collected the data of adverse reactions through self-reporting and calculated the anti-SARS-CoV-2 spike-specific antibody titer for all participants.

Results

The antibody titer of the prior-infection group in first antibody test was significantly higher than that of the control group in the second antibody test. There was no significant difference in adverse reactions between the prior infection group receiving its first vaccination and the control group receiving its second vaccination.

Conclusion

Our study shows that the antibody response following the first vaccination in the prior COVID-19 infection group was found to be comparable to that of the second vaccination in the control group; however, the evaluation of adverse reactions was inadequate and further, large-scale studies are needed.

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  1. ScreenIT

    SciScore for 10.1101/2021.07.18.21260579: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The protocol for this research project was approved by the Ethics Committee of the institution, it conforms to the provision of the Declaration of Helsinki (Committee of the Association of EISEIKAI Medical and Healthcare Corporation Minamitama Hospital, Approval No. 2020-Ack-19) and written consent was obtained from all the participants.
    Consent: The protocol for this research project was approved by the Ethics Committee of the institution, it conforms to the provision of the Declaration of Helsinki (Committee of the Association of EISEIKAI Medical and Healthcare Corporation Minamitama Hospital, Approval No. 2020-Ack-19) and written consent was obtained from all the participants.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power AnalysisStatistical Analyses: A sample size of 475 participants was determined based upon 70% power, 0.05 significance level, 0.8 effect size, 37 allocation ration, and 20% attrition.

    Table 2: Resources

    Antibodies
    SentencesResources
    We obtained 5-ml blood samples from the intermediate cubital vein and calculated the anti-SARS-CoV-2 spike-specific antibody titer for each participant (Elecsys® Anti-SARS-CoV-2 S RUO, Roche Diagnostics K.K.) 1) before vaccination (baseline), 2) seven to twenty days after the first dose of the vaccination (first antibody test), and 3) seven to twenty days after the second dose of the vaccination (second antibody test).
    anti-SARS-CoV-2
    suggested: None
    Software and Algorithms
    SentencesResources
    Data were analyzed with the Statistical Package for the Social Sciences, version 26.0 (SPSS, Chicago, IL, USA).
    Statistical Package for the Social Sciences
    suggested: (SPSS, RRID:SCR_002865)
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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. First, we did not calculate the lymphocyte activity of either group, and we could not monitor the whole immune system response. Second, although we established a relatively large effect size and although the difference in antibody titer between the two groups was clear, we may have needed a large sample size to assess adverse reactions. Third, we only included relatively healthy medical workers, not participants with severe complications, and this may have reduced the differences between the prior COVID-19 infection group and the control group. In conclusion, our study showed that the antibody response to the first vaccination in the prior COVID-19 infection group was found to be comparable to that of the second vaccination in the non-COVID-19 infection group. On the other hand, the evaluation of adverse reactions is inadequate, and further large-scale studies are needed.

    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.

  2. Version published to 10.1101/2021.07.18.21260579 on medRxiv