Safety and immunogenicity of Nanocovax, a SARS-CoV-2 recombinant spike protein vaccine: Interim results of a double-blind, randomised controlled phase 1 and 2 trial

  1. Thuy P. Nguyen
  2. Quyet Do
  3. Lan T. Phan
  4. Duc V. Dinh
  5. Hiep Khong
  6. Luong V. Hoang
  7. Thuong V. Nguyen
  8. Hung N. Pham
  9. Men V. Chu
  10. Toan T. Nguyen
  11. Quang D. Pham
  12. Tri M. Le
  13. Tuyen N.T. Trang
  14. Thanh T. Dinh
  15. Thuong V. Vo
  16. Thao T. Vu
  17. Quynh B.P. Nguyen
  18. Vuong T. Phan
  19. Luong V. Nguyen
  20. Giang T. Nguyen
  21. Phong M. Tran
  22. Thuan D. Nghiem
  23. Tien V. Tran
  24. Tien G. Nguyen
  25. Tuynh Q. Tran
  26. Linh T. Nguyen
  27. Anh T. Do
  28. Dung D. Nguyen
  29. Son A. Ho
  30. Viet T. Nguyen
  31. Dung T. Pham
  32. Hieu B. Tran
  33. Son T. Vu
  34. Su X. Hoang
  35. Trung M. Do
  36. Hoan Vu Ngoc
  37. Xuan T. Nguyen
  38. Giang Q. Le
  39. Ton Tran
  40. Thang M. Cao
  41. Huy M. Dao
  42. Thao T.T. Nguyen
  43. Uyen Y Doan
  44. Vy T.T. Le
  45. Linh P. Tran
  46. Ngoc M. Nguyen
  47. Ngoc T. Nguyen
  48. Hang T.T. Pham
  49. Quan H. Nguyen
  50. Hieu T. Nguyen
  51. Hang L.K. Nguyen
  52. Vinh T. Tran
  53. Mai T.N. Tran
  54. Truc T.T. Nguyen
  55. Phat T. Ha
  56. Hieu T. Huynh
  57. Khanh D. Nguyen
  58. Ung T. Thuan
  59. Chung C. Doan
  60. Si M. Do

Reviewed by

Read the full article See related articles

Discuss this preprint

Start a discussion What are Sciety discussions?

Listed in

Log in to save this article

Abstract

No abstract available

Article activity feed

  1. Version published to 10.1016/j.lanwpc.2022.100474
  2. ScreenIT

    SciScore for 10.1101/2021.07.22.21260942: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: All participants provided written consent before being enrolled into the trial.
    Field Sample Permit: The trials were designed and funded by Nanogen Pharmaceutical Biotechnology JSC and the Ministry of Science and Technology (MOST) of Vietnam.
    IRB: The trial protocol was approved by the Ethics Committee/Protocol Review Board of the Ministry of Health (Vietnam) and was performed in accordance with the ICH-GCP good clinical practice guidelines, with an ethical policy consistent with the “Declaration of Helsinki” and applicable Vietnamese laws and regulations.
    Sex as a biological variableEligible participants were healthy men and nonpregnant women, 18 to 50 years of age with body-mass index (BMI) of 18 to 27 kg/m2 (table S2).
    RandomizationThis was a randomized, double-blind, placebo-controlled study (figure 1).
    BlindingTrial staffs responsible for the vaccine preparation and administration, and participants were unaware of vaccine assignment.
    Power AnalysisSample size of phase 1 was not based on formal statistical power calculation but on the range of 30 – 150 recommended in Article 10 of Appendix 10/2020/TT-BYT by Vietnam Ministry of Health.

    Table 2: Resources

    Antibodies
    SentencesResources
    Immune response analysis: The geometric anti-S IgG antibody and neutralizing ability of SARS-CoV-2 antibody in the sera at the screening stage is considered as baseline values.
    anti-S IgG
    suggested: None

    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:
    Limitations of these phase 1 and 2 trials are limited ethnic diversity (almost exclusively Vietnamese Kinh people), short follow-up duration, healthy participants only and the lack of convalescent serum data. Without comparison of vaccine responses to convalescent sera from covid-19 patients, it is difficult to compare and contrast the immunogenicity of different vaccines and hence the projected efficacy. This shortcoming will be addressed in phase 3 trial. In conclusion, Nanocovax is highly safe and immunogenic. Dose strength of 25 mcg is selected for phase 3 to evaluate the vaccine efficacy.

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

    IdentifierStatusTitle
    NCT04683484RecruitingA Clinical Trial to Assess the Safety and Immunogenicity of …

    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 10.1101/2021.07.22.21260942 on medRxiv