Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine

  1. Karen J. Hager
  2. Gonzalo Pérez Marc
  3. Philipe Gobeil
  4. Ricardo S. Diaz
  5. Gretchen Heizer
  6. Conrado Llapur
  7. Alexander I. Makarkov
  8. Eduardo Vasconcellos
  9. Stéphane Pillet
  10. Fernando Riera
  11. Pooja Saxena
  12. Priscila Geller Wolff
  13. Kapil Bhutada
  14. Garry Wallace
  15. Hessam Aazami
  16. Christine E. Jones
  17. Fernando P. Polack
  18. Luciana Ferrara
  19. Judith Atkins
  20. Iohann Boulay
  21. Jiwanjeet Dhaliwall
  22. Nathalie Charland
  23. Manon M.J. Couture
  24. Julia Jiang-Wright
  25. Nathalie Landry
  26. Sophie Lapointe
  27. Aurélien Lorin
  28. Asif Mahmood
  29. Lawrence H. Moulton
  30. Emmy Pahmer
  31. Julie Parent
  32. Annie Séguin
  33. Luan Tran
  34. Thomas Breuer
  35. Maria-Angeles Ceregido
  36. Marguerite Koutsoukos
  37. François Roman
  38. Junya Namba
  39. Marc-André D’Aoust
  40. Sonia Trepanier
  41. Yosuke Kimura
  42. Brian J. Ward

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Abstract

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  1. Version published to 10.1056/nejmoa2201300
  2. ScreenIT

    SciScore for 10.1101/2022.01.17.22269242: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: All participants provided written informed consent before being enrolled.
    IRB: An independent Institutional Review Board (IRB) or Ethics Committee (EC) approved the protocol, protocol amendments and consent forms.
    Sex as a biological variablenot detected.
    RandomizationThe objectives of the randomized, observed-blinded, placebo-controlled Phase 3 portion of the trial were the determination of efficacy, safety and, in a subset of participants, immunogenicity of CoVLP+AS03.
    BlindingSafety oversight was provided by the Safety Monitoring Team (SMT) that reviewed safety data on a regular basis in a blinded manner.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.

    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:
    Like any Phase 3 study done under pandemic conditions, the current trial had limitations, the most obvious of which are the limited number of older adults and smaller proportion of adults with comorbidities who were able to participate due to on-going vaccine roll-out programs and the relatively short period of follow-up due to the event-driven design. However, immunogenicity data from the Phase 2 portion of the current study demonstrated strong neutralizing antibody and cellular responses in all three study populations after two doses of CoVLP+AS03 41, and 6-month follow-up of CoVLP+AS03 recipients in the preceding Phase 1 study demonstrated that both humoral and cellular responses were durable 71. Although relatively few severe cases (three in the ITT set and two in the PP set) and two hospitalizations occurred in this study, all fell into the placebo arm and the overall efficacy against moderate and severe disease combined was 78.1% and 78.8% in the ITT and PP sets, respectively, suggesting that protection against the more severe manifestations of COVID-19 caused by a range of variants was substantial. This study is still ongoing, and a wide range of secondary outcomes will be reported as the data become available. The primary vaccine efficacy and safety data presented here demonstrate that substantial protection against a range of VoC can be provided by two doses of CoVLP+AS03. New cases continue to be identified in the ongoing Phase 3 study and the efficacy of this new c...

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

    IdentifierStatusTitle
    NCT04636697Active, not recruitingStudy of a Recombinant Coronavirus-Like Particle COVID-19 Va…

    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 10.1101/2022.01.17.22269242 on medRxiv