Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study

  1. Saranya Sridhar
  2. Arnel Joaquin
  3. Matthew I Bonaparte
  4. Agustin Bueso
  5. Anne-Laure Chabanon
  6. Aiying Chen
  7. Roman M Chicz
  8. David Diemert
  9. Brandon J Essink
  10. Bo Fu
  11. Nicole A Grunenberg
  12. Helene Janosczyk
  13. Michael C Keefer
  14. Doris M Rivera M
  15. Ya Meng
  16. Nelson L Michael
  17. Sonal S Munsiff
  18. Onyema Ogbuagu
  19. Vanessa N Raabe
  20. Randall Severance
  21. Enrique Rivas
  22. Natalya Romanyak
  23. Nadine G Rouphael
  24. Lode Schuerman
  25. Lawrence D Sher
  26. Stephen R Walsh
  27. Judith White
  28. Dalia von Barbier
  29. Guy de Bruyn
  30. Richard Canter
  31. Marie-Helene Grillet
  32. Maryam Keshtkar-Jahromi
  33. Marguerite Koutsoukos
  34. Denise Lopez
  35. Roger Masotti
  36. Sandra Mendoza
  37. Catherine Moreau
  38. Maria Angeles Ceregido
  39. Shelly Ramirez
  40. Ansoyta Said
  41. Fernanda Tavares-Da-Silva
  42. Jiayuan Shi
  43. Tina Tong
  44. John Treanor
  45. Carlos A Diazgranados
  46. Stephen Savarino

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Abstract

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  1. Version published to 10.1016/s1473-3099(21)00764-7
  2. ScreenIT

    SciScore for 10.1101/2021.10.08.21264302: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The protocol and amendments were approved by applicable Independent Ethics Committees/Institutional Review Boards, including the Advarra Institutional Review Board for the USA, and the regulatory agencies as per local regulations.
    Consent: Written informed consent was obtained from the participants before any study procedures were performed.
    Sex as a biological variableWomen who were pregnant or lactating, or, for those of childbearing potential, not using an effective method of contraception or abstinence, were excluded.
    RandomizationStudy design and participants: This is an ongoing Phase 2, randomised, modified double-blind, parallel group, dose-ranging study (clinicaltrials.gov NCT04762680).
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Binding antibody (BAb) profiles were assessed by measuring SARS-CoV-2 anti-S protein IgG antibodies with an indirect enzyme-linked immunosorbent assay (ELISA) (Nexelis, Laval, Quebec, Canada), as described previously.
    anti-S protein IgG
    suggested: None

    Results from OddPub: Thank you for sharing your data.

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Other limitations include that information on the durability of the immune response is not available from this interim analysis, and that antigen doses lower than 5 μg, which could be of interest for boosting primed individuals, were not evaluated here. In summary, two doses of the CoV2 preS dTM-AS03 vaccine candidate demonstrated an acceptable safety profile and robust immunogenicity in SARS-CoV-2 naïve adults, including in individuals aged 60 years and older and those with high-risk medical conditions. Based on these results, two formulations of the CoV2 preS dTM-AS03 vaccine candidate, a monovalent D614G and a bivalent D614G and Beta variant vaccine, are undergoing efficacy evaluation in Phase 3 trials. Furthermore, the high neutralising titres and acceptable safety after a single vaccine dose observed in participants with evidence of prior SARS-CoV-2 infection indicate the possibility of developing a formulation with a lower antigen dose, and a single dose vaccination strategy, for use as a booster for previously primed adults.

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

    IdentifierStatusTitle
    NCT04762680RecruitingStudy of Recombinant Protein Vaccines With Adjuvant as a Pri…
    NCT04904549RecruitingStudy of Monovalent and Bivalent Recombinant Protein Vaccine…

    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 10.1101/2021.10.08.21264302v2 on medRxiv
  4. Version published to 10.1101/2021.10.08.21264302v1 on medRxiv