Safety and immunogenicity of two recombinant DNA COVID-19 vaccines containing the coding regions of the spike or spike and nucleocapsid proteins: an interim analysis of two open-label, non-randomised, phase 1 trials in healthy adults

  1. Jin Young Ahn
  2. Jeongsoo Lee
  3. You Suk Suh
  4. Young Goo Song
  5. Yoon-Jeong Choi
  6. Kyoung Hwa Lee
  7. Sang Hwan Seo
  8. Manki Song
  9. Jong-Won Oh
  10. Minwoo Kim
  11. Han Young Seo
  12. Jeong-Eun Kwak
  13. Jin Won Youn
  14. Jung Won Woo
  15. Eui-Cheol Shin
  16. Young Chul Sung
  17. Su-Hyung Park
  18. Jun Yong Choi

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Abstract

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  1. Version published to 10.1016/s2666-5247(21)00358-x
  2. ScreenIT

    SciScore for 10.1101/2021.05.26.21257700: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: Written informed consent was obtained from all participants.
    IRB: This study was approved in South Korea by the Korea Ministry of Food and Drug Safety (reference 20200261849) and the Institutional Review Board of Severance Hospital (IRB No. 4-2020-1220).
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    The analyses were performed using IBM SPSS statistics and GraphPad Prism, version 8.4.1., and 95% CIs were calculated using the Clopper-Pearson method.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)
    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

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

    IdentifierStatusTitle
    NCT04785144RecruitingSafety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) V…
    NCT04445389RecruitingSafety and Immunogenicity Study of GX-19, a COVID-19 Prevent…
    NCT04715997RecruitingSafety and Immunogenicity Study of GX-19N, a COVID-19 Preven…
    NCT044445389Trial number did not resolve on clinicaltrials.gov. Is the number correct?NA

    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 10.1101/2021.05.26.21257700v1 on medRxiv