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Efficacy and Safety of a Protein-Based Sars-Cov-2 Vaccine: A Randomized Clinical Trial Publisher Pubmed



Mostafavi E1 ; Eybpoosh S1 ; Karamouzian M2, 3, 4 ; Khalili M5 ; Hajimaghsoudi S6, 7 ; Salehivaziri M8 ; Khamesipour A9 ; Jalali T8 ; Nakhaeizadeh M7 ; Sharifi H2, 7 ; Mansoori Y10 ; Keramat F11 ; Ghodrati S12, 13 ; Javanian M14 Show All Authors
Authors
  1. Mostafavi E1
  2. Eybpoosh S1
  3. Karamouzian M2, 3, 4
  4. Khalili M5
  5. Hajimaghsoudi S6, 7
  6. Salehivaziri M8
  7. Khamesipour A9
  8. Jalali T8
  9. Nakhaeizadeh M7
  10. Sharifi H2, 7
  11. Mansoori Y10
  12. Keramat F11
  13. Ghodrati S12, 13
  14. Javanian M14
  15. Doroud D15
  16. Omrani MD16, 17
  17. Asadi H17, 18
  18. Pouriayevali MH8
  19. Ghasemian R19
  20. Farshidi H20
  21. Pourahmad M21
  22. Ghasemzadeh I22
  23. Mounesan L1
  24. Darvishian M23
  25. Mirjalili MR24
  26. Toledoromani ME25
  27. Valenzuelasilva C26
  28. Verezbencomo V27
  29. Gouya MM28, 29
  30. Emadikoochak H30
  31. Haghdoost AA6
  32. Biglari A17, 31
Show Affiliations
Authors Affiliations
  1. 1. Department of Epidemiology and Biostatistics, Research Centre for Emerging and Reemerging Infectious Diseases, Pasteur Institute of Iran, Tehran, Iran
  2. 2. HIV/STI Surveillance Research Center, WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran
  3. 3. School of Public Health, Brown University, Providence, RI, United States
  4. 4. Centre on Drug Policy Evaluation, St. Michael's Hospital, Toronto, ON, Canada
  5. 5. The Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, ON, Canada
  6. 6. Modeling in Health Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran
  7. 7. Department of Biostatistics and Epidemiology, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran
  8. 8. COVID-19 National Reference Laboratory, Pasteur Institute of Iran, Tehran, Iran
  9. 9. Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran
  10. 10. Shiraz University of Medical Sciences, Shiraz, Iran
  11. 11. Brucellosis Research Center, Hamadan University of Medical Sciences, Hamadan, Iran
  12. 12. Internal Medicine Department, Zanjan University of Medical Sciences, Zanjan, Iran
  13. 13. Zanjan Metabolic Diseases Research Center, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran
  14. 14. Infectious Diseases and Tropical Medicine Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran
  15. 15. Quality Control Department, Production and Research Complex, Pasteur Institute of Iran, Tehran, Iran
  16. 16. Department of Genetics, School of Medicine, Urogenital Stem Cell Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  17. 17. Pasteur Institute of Iran, Tehran, Iran
  18. 18. Department of Health Information Management, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran
  19. 19. Department of Infectious Diseases, Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran
  20. 20. Cardiovascular Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran
  21. 21. Department of Infectious Diseases, Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
  22. 22. Research Center of Tropical and Infectious Diseases, Kerman University of Medical Sciences, Kerman, Iran
  23. 23. Cancer Control Research, BC Cancer Research Centre, Vancouver, BC, Canada
  24. 24. Shahid Sadoughi University of Medical Sciences, Yazd, Iran
  25. 25. Pedro Kouri Tropical Medicine Institute, Havana, Cuba
  26. 26. Cybernetics, Mathematics and Physics Institute, Havana, Cuba
  27. 27. Finlay Vaccine Institute, Havana, United States
  28. 28. Centre for Communicable Disease Control, Ministry of Health and Medical Education, Tehran, Iran
  29. 29. Department of Infectious Disease and Tropical Medicine, School of Medicine, Iran University of Medical Sciences, Tehran, Iran
  30. 30. Department of Infectious Disease, School of Medicine, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran
  31. 31. School of Medicine, Tehran University of Medical Sciences, Tehran, Iran

Source: JAMA Network Open Published:2023


Abstract

Importance: The protein-based SARS-CoV-2 vaccines FINLAY-FR-2 (Soberana 02) and FINLAY-FR-1A (Soberana Plus) showed good safety and immunogenicity in phase 1 and 2 trials, but the clinical efficacy of the vaccine remains unknown. Objective: To evaluate the efficacy and safety of a 2-dose regimen of FINLAY-FR-2 (cohort 1) and a 3-dose regimen of FINLAY-FR-2 with FINLAY-FR-1A (cohort 2) in Iranian adults. Design, Setting, and Participants: A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial was conducted at 6 cities in cohort 1 and 2 cities in cohort 2. Participants included individuals aged 18 to 80 years without uncontrolled comorbidities, coagulation disorders, pregnancy or breastfeeding, recent immunoglobulin or immunosuppressive therapy, and clinical presentation or laboratory-confirmed COVID-19 on enrollment. The study was conducted from April 26 to September 25, 2021. Interventions: In cohort 1, 2 doses of FINLAY-FR-2 (n = 13857) or placebo (n = 3462) were administered 28 days apart. In cohort 2, 2 doses of FINLAY-FR-2 plus 1 dose of FINLAY-FR-1A (n = 4340) or 3 placebo doses (n = 1081) were administered 28 days apart. Vaccinations were administered via intramuscular injection. Main Outcomes and Measures: The primary outcome was polymerase chain reaction-confirmed symptomatic COVID-19 infection at least 14 days after vaccination completion. Other outcomes were adverse events and severe COVID-19. Intention-to-treat analysis was performed. Results: In cohort 1 a total 17319 individuals received 2 doses and in cohort 2 5521 received 3 doses of the vaccine or placebo. Cohort 1 comprised 60.1% men in the vaccine group and 59.1% men in the placebo group; cohort 2 included 59.8% men in the vaccine group and 59.9% in the placebo group. The mean (SD) age was 39.3 (11.9) years in cohort 1 and 39.7 (12.0) years in cohort 2, with no significant difference between the vaccine and placebo groups. The median follow-up time in cohort 1 was 100 (IQR, 96-106) days and, in cohort 2, 142 (137-148) days. In cohort 1, 461 (3.2%) cases of COVID-19 occurred in the vaccine group and 221 (6.1%) in the placebo group (vaccine efficacy: 49.7%; 95% CI, 40.8%-57.3%) vs 75 (1.6%) and 51 (4.3%) in cohort 2 (vaccine efficacy: 64.9%; 95% CI, 49.7%-59.5%). The incidence of serious adverse events was lower than 0.1%, with no vaccine-related deaths. Conclusions and Relevance: In this multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of the efficacy and safety of FINLAY-FR-2 and FINLAY-FR-1A, 2 doses of FINLAY-FR-2 plus the third dose of FINLAY-FR-1A showed acceptable vaccine efficacy against symptomatic COVID-19 as well as COVID-19-related severe infections. Vaccination was generally safe and well tolerated. Therefore, Soberana may have utility as an option for mass vaccination of the population, especially in resource-limited settings, because of its storage condition and affordable price. Trial Registration: isrctn.org Identifier: IRCT20210303050558N1. © 2023 American Medical Association. All rights reserved.
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