Comparison of the reactogenicity and immunogenicity of a reduced and standard booster dose of the mRNA COVID-19 vaccine in healthy adults after two doses of inactivated vaccine

  1. Sitthichai Kanokudom
  2. Suvichada Assawakosri
  3. Nungruthai Suntronwong
  4. Jira Chansaenroj
  5. Chompoonut Auphimai
  6. Pornjarim Nilyanimit
  7. Preeyaporn Vichaiwattana
  8. Thanunrat Thongmee
  9. Ritthideach Yorsaeng
  10. Thaneeya Duangchinda
  11. Warangkana Chantima
  12. Pattarakul Pakchotanon
  13. Donchida Srimuan
  14. Thaksaporn Thatsanatorn
  15. Sirapa Klinfueng
  16. Juthathip Mongkolsapaya
  17. Natthinee Sudhinaraset
  18. Nasamon Wanlapakorn
  19. Sittisak Honsawek
  20. Yong Poovorawan

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Abstract

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  1. Version published to 10.1016/j.vaccine.2022.08.033
  2. ScreenIT

    SciScore for 10.1101/2022.03.01.22271735: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The study protocol was approved by the Institutional Review Board (IRB) in the Faculty of Medicine at Chulalongkorn University (IRB690/64).
    Consent: Written informed consent was obtained from participants prior to enrollment.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power AnalysisStatistical Analysis: The sample size was calculated using G*power software version 3.1.9.6 (based on conventional effect size = 0.25, given significance level (α) = 0.05, power (1-β) = 0.8, numerator degree of freedom = 3, and number of groups = 4).

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical Analysis: The sample size was calculated using G*power software version 3.1.9.6 (based on conventional effect size = 0.25, given significance level (α) = 0.05, power (1-β) = 0.8, numerator degree of freedom = 3, and number of groups = 4).
    G*power
    suggested: (G*Power, RRID:SCR_013726)
    The graphical representation and statistical analyses were carried out using GraphPad Prism version 9.3.1.
    GraphPad Prism
    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:
    This study had some limitations. The surrogate virus neutralization test against the delta variant reached the upper limit of >97% inhibition. However, the FRNT50 result could explain why there were no significant differences in neutralizing activity against the delta and omicron variants. In addition, this study partially relied on subjects who received standard-dose immunization in another study. A more recent report of the standard-dose regimen should be used as the comparison group for the reduced-dose regimen. A follow-up study is underway to determine the durability of the booster vaccine. In conclusion, there were no significant differences between administration of the reduced and standard doses of mRNA COVID-19 vaccine in participants who previously received inactivated CV vaccine. This study may inform decision-making regarding the use of reduced mRNA vaccine doses in healthy adults who were immunized with CV.

    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 10.1101/2022.03.01.22271735v1 on medRxiv