A randomized clinical trial of a booster dose with low versus standard dose of AZD1222 in adult after 2 doses of inactivated vaccines

  1. Sira Nanthapisal
  2. Thanyawee Puthanakit
  3. Peera Jaru-Ampornpan
  4. Rapisa Nantanee
  5. Pimpayao Sodsai
  6. Orawan Himananto
  7. Jiratchaya Sophonphan
  8. Pintip Suchartlikitwong
  9. Narin Hiransuthikul
  10. Pornpimon Angkasekwinai
  11. Auchara Tangsathapornpong
  12. Nattiya Hirankarn

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Abstract

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  1. Version published to 10.1016/j.vaccine.2022.03.036
  2. ScreenIT

    SciScore for 10.1101/2022.02.15.22270974: (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 study enrollment.
    IRB: Institutional review board of Faculty of Medicine, Thammasat University (MTU-EC-PE1-182/64) and Faculty of Medicine, Chulalongkorn University (IRB No. 600/64) approved this study.
    Sex as a biological variablenot detected.
    RandomizationThis is a double-blinded, randomized, controlled trial.
    BlindingTherefore, the participants and blinded study team were not aware of the randomization arms.
    Power Analysis2.5 Statistical analysis: The sample size was calculated using a non-inferiority criterion for the geometric mean ratio (GMR) of sVNT against wild type and delta variant, and anti-S-RBD IgG, comparing LD to SD.

    Table 2: Resources

    Antibodies
    SentencesResources
    Correlation between the levels of anti-S-RBD IgG and receptor-blocking antibodies as measured by sVNT was analyzed for both wild type and delta strains by non-linear regression fit in GraphPad Prism 9 (GraphPad software, San Diego, CA).
    anti-S-RBD IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    Correlation between the levels of anti-S-RBD IgG and receptor-blocking antibodies as measured by sVNT was analyzed for both wild type and delta strains by non-linear regression fit in GraphPad Prism 9 (GraphPad software, San Diego, CA).
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)

    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:
    The limitation included the interval from last vaccination was only 2-3 months after completion of 2-dose CoronaVac. Though in the real world, the booster might be given at longer interval from last CoronaVac, in which we expected to have at least similar or even higher immunogenicity. Secondly, this study included healthy adults, and have no data among high-risk groups, such as the elderly or the immunocompromised patients. Thirdly, the follow up of the participants are ongoing to observe the kinetic of antibody decline and risk of breakthrough infection if any occurred. Lastly, this study did not perform sVNT for recently emerged variants e.g., Omicron, however, the comparable T cell responses between standard and low dose AZD1222 booster could likely prevent severe symptoms of COVID-19 caused by these variants.

    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 10.1101/2022.02.15.22270974v1 on medRxiv