Immunogenicity and safety of booster dose of S-268019-b or BNT162b2 in Japanese participants: An interim report of phase 2/3, randomized, observer-blinded, noninferiority study

  1. Masaharu Shinkai
  2. Takuhiro Sonoyama
  3. Akari Kamitani
  4. Risa Yokokawa Shibata
  5. Naomi M. Seki
  6. Shinya Omoto
  7. Masahiro Shinoda
  8. Takashi Sato
  9. Naoki Ishii
  10. Kenji Igarashi
  11. Mari Ariyasu

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Abstract

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  1. Version published to 10.1016/j.vaccine.2022.06.032
  2. ScreenIT

    SciScore for 10.1101/2022.03.03.22271827: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The study (jRCT2031210470) was conducted in compliance with the protocol, the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice Guidelines, other applicable laws and regulations, and was approved by Institutional Review Board of Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai.
    Consent: All participants gave their written informed consent.
    Sex as a biological variablenot detected.
    RandomizationStudy design and participants: This phase 2/3, single-center, randomized, observer-blinded, active-controlled, noninferiority trial comprised three periods: screening (day −28 to −1), evaluation (day 1 to 29), and follow-up (day 30 to 365) (Figure 1).
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    The co-primary endpoints included day 29 geometric mean titer (GMT) and seroresponse rate (SRR) for SARS-CoV-2 neutralizing antibodies.
    SARS-CoV-2 neutralizing antibodies.
    suggested: None
    These included GMT, geometric mean fold rise (GMFR), and SRR for neutralizing antibodies and anti-spike protein immunoglobulin G (IgG) antibodies on days 15 and 29.
    anti-spike protein immunoglobulin G (IgG
    suggested: (Imported from the IEDB Cat# 3G3, RRID:AB_2848064)
    The immunogenicity subset included participants who received ≥1 dose of the study intervention, had ≥1 post-vaccination immunogenicity data, and were negative for anti-SARS-CoV-2 N-protein antibody at screening.
    anti-SARS-CoV-2 N-protein
    suggested: None
    Software and Algorithms
    SentencesResources
    All analyses were performed using SAS® v9.4 (SAS Institute, NC, USA). (See Supplementary Appendix for detailed methods and statistical analyses).
    SAS®
    suggested: (SASqPCR, RRID:SCR_003056)
    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 must however be acknowledged. The study (1) was designed for an immunocompetent adult Japanese cohort with no known history of SARS-CoV-2 infection and prior vaccination with only tozinameran, and (2) has a short follow-up duration for interim analysis and relatively small sample size. Also, this study was not powered to demonstrate clinical efficacy. Despite these limitations, a booster dose of the recombinant spike protein vaccine, S-268019-b, elicited robust immunogenicity against SARS-CoV-2, with mostly low-grade reactogenicity.

    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 10.1101/2022.03.03.22271827 on medRxiv