A Randomized Clinical Trial Using CoronaVac or BNT162b2 Vaccine as a Third Dose in Adults Vaccinated with Two Doses of CoronaVac

  1. Chris Ka Pun Mok
  2. Chunke Chen
  3. Karen Yiu
  4. Tat-On Chan
  5. Kiu Cheung Lai
  6. Kwun Cheung Ling
  7. Yuanxin Sun
  8. David S. Hui
  9. Samuel M. S. Cheng
  10. Malik Peiris

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Abstract

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  1. Version published to 10.1164/rccm.202111-2655le
  2. ScreenIT

    SciScore for 10.1101/2021.11.02.21265843: (What is this?)

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

    Table 1: Rigor

    EthicsField Sample Permit: 230 out of 360 in our cohort showed the sVNT results below 60% in their plasma specimens which were collected at one month after the second dose.
    IRB: Study approval: The study was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (Ref no: 2020.229) and all participants provided written consent.
    Consent: Study approval: The study was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (Ref no: 2020.229) and all participants provided written consent.
    Sex as a biological variablenot detected.
    RandomizationThe participants were randomized to receive either BNT162b2 (n=40) or CoronaVac (n=40) as the third dose.
    Blindingnot detected.
    Power AnalysisSample size calculation: The sample size was calculated based on the results of our previous study (10).

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    All analyses were performed in R (version 4.1.0; R Foundation for Statistical Computing) or Prism 9 (Graphpad).
    Graphpad
    suggested: (GraphPad, RRID:SCR_000306)

    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:
    There were some limitations in our study. Firstly, the sample size in our study was relatively small, but we have shown that the large difference of the results between the two groups and provided sufficient statistical power to draw our conclusion. A larger scale RCT will be needed especially for evaluating those rare adverse effects. Secondly, our study cohort only focused on those who had poor response to the CoronaVac that were urgently in need for the third dose. In routine practice, we will need to use booster doses without serological testing to identify poor antibody responders. Finally, T cell responses were not assessed in this study. Our previous report found that CoronaVac elicited more potent T cell responses than the BNT162b2 vaccine (10). We will further study the T cell response from this cohort together with the samples collected at their six-month time point.

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

    IdentifierStatusTitle
    NCT04611243RecruitingLung Function, Exercise Capacity, and Serology Responses in …

    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 10.1101/2021.11.02.21265843v1 on medRxiv