Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: A randomised, comparator-controlled, phase 2 trial

  1. Vu Dinh Thiem
  2. Dang Duc Anh
  3. Vu Hai Ha
  4. Nguyen Van Thom
  5. Tran Cong Thang
  6. Jose Mateus
  7. Juan Manuel Carreño
  8. Rama Raghunandan
  9. Nguyen Mai Huong
  10. Laina D. Mercer
  11. Jorge Flores
  12. E. Alexandar Escarrega
  13. Ariel Raskin
  14. Duong Huu Thai
  15. Le Van Be
  16. Alessandro Sette
  17. Bruce L. Innis
  18. Florian Krammer
  19. Daniela Weiskopf

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Abstract

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  1. Version published to 10.1016/j.vaccine.2024.126542
  2. Rapid Reviews Infectious Diseases

    Judd Walson

    Review 2: "Safety and Immunogenicity of an Inactivated Recombinant Newcastle Disease Virus Vaccine Expressing SARS-CoV-2 Spike: A Randomised, Comparator-Controlled, Phase 2 Trial"

    The reviewers express important concern. Among them, they point out that the main outcome reported in the paper is not the same one that was pre-registered. The comparator arm uses a vaccine that is obsolete and not currently recommended.

  3. Rapid Reviews Infectious Diseases

    Jun Zhang, Qi Chen

    Review 1: "Safety and Immunogenicity of an Inactivated Recombinant Newcastle Disease Virus Vaccine Expressing SARS-CoV-2 Spike: A Randomised, Comparator-Controlled, Phase 2 Trial"

    The reviewers express important concern. Among them, they point out that the main outcome reported in the paper is not the same one that was pre-registered. The comparator arm uses a vaccine that is obsolete and not currently recommended.

  5. Version published to 10.1101/2023.11.30.23299208v1 on medRxiv