Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine: A Randomized Clinical Trial.

Autor:	Mostafavi E; Department of Epidemiology and Biostatistics, Research Centre for Emerging and Reemerging Infectious Diseases, Pasteur Institute of Iran, Tehran, Iran., Eybpoosh S; Department of Epidemiology and Biostatistics, Research Centre for Emerging and Reemerging Infectious Diseases, Pasteur Institute of Iran, Tehran, Iran., Karamouzian M; HIV/STI Surveillance Research Center, and WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.; School of Public Health, Brown University, Providence, Rhode Island.; Centre on Drug Policy Evaluation, St. Michael's Hospital, Toronto, Ontario, Canada., Khalili M; The Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada., Haji-Maghsoudi S; Modeling in Health Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.; Department of Biostatistics and Epidemiology, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran., Salehi-Vaziri M; COVID-19 National Reference Laboratory, Pasteur Institute of Iran, Tehran, Iran., Khamesipour A; Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Tehran, Iran., Jalali T; COVID-19 National Reference Laboratory, Pasteur Institute of Iran, Tehran, Iran., Nakhaeizadeh M; Department of Biostatistics and Epidemiology, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran., Sharifi H; HIV/STI Surveillance Research Center, and WHO Collaborating Center for HIV Surveillance, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.; Department of Biostatistics and Epidemiology, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran., Mansoori Y; Shiraz University of Medical Sciences, Shiraz, Iran., Keramat F; Brucellosis Research Center, Hamadan University of Medical Sciences, Hamadan, Iran., Ghodrati S; Internal Medicine Department, Zanjan University of Medical Sciences, Zanjan, Iran.; Zanjan Metabolic Diseases Research Center, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran., Javanian M; Infectious Diseases and Tropical Medicine Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran., Doroud D; Quality Control Department, Production and Research Complex, Pasteur Institute of Iran, Tehran, Iran., Omrani MD; Department of Genetics, School of Medicine, Urogenital Stem Cell Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.; Pasteur Institute of Iran, Tehran, Iran., Asadi H; Pasteur Institute of Iran, Tehran, Iran.; Department of Health Information Management, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran., Pouriayevali MH; COVID-19 National Reference Laboratory, Pasteur Institute of Iran, Tehran, Iran., Ghasemian R; Department of Infectious Diseases, Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran., Farshidi H; Cardiovascular Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran., Pourahmad M; Department of Infectious Diseases, Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran., Ghasemzadeh I; Research Center of Tropical and Infectious Diseases, Kerman University of Medical Sciences, Kerman, Iran., Mounesan L; Department of Epidemiology and Biostatistics, Research Centre for Emerging and Reemerging Infectious Diseases, Pasteur Institute of Iran, Tehran, Iran., Darvishian M; Cancer Control Research, BC Cancer Research Centre, Vancouver, British Columbia, Canada., Mirjalili MR; Shahid Sadoughi University of Medical Sciences, Yazd, Iran., Toledo-Romani ME; Pedro Kourí Tropical Medicine Institute, Havana, Cuba., Valenzuela-Silva C; Cybernetics, Mathematics and Physics Institute, Havana, Cuba., Verez-Bencomo V; Finlay Vaccine Institute, Havana., Gouya MM; Centre for Communicable Disease Control, Ministry of Health and Medical Education, Tehran, Iran.; Department of Infectious Disease and Tropical Medicine, School of Medicine, Iran University of Medical Sciences, Tehran, Iran., Emadi-Koochak H; Department of Infectious Disease, School of Medicine, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran., Haghdoost AA; Modeling in Health Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran., Biglari A; Pasteur Institute of Iran, Tehran, Iran.; School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.
Jazyk:	angličtina
Zdroj:	JAMA network open [JAMA Netw Open] 2023 May 01; Vol. 6 (5), pp. e2310302. Date of Electronic Publication: 2023 May 01.
DOI:	10.1001/jamanetworkopen.2023.10302
Abstrakt:	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 = 13 857) 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 17 319 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.
Databáze:	MEDLINE
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