Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2023 May 1;6(5):e2310302.
doi: 10.1001/jamanetworkopen.2023.10302.

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

Ehsan Mostafavi  1 , Sana Eybpoosh  1 , Mohammad Karamouzian  2   3   4 , Malahat Khalili  5 , Saiedeh Haji-Maghsoudi  6   7 , Mostafa Salehi-Vaziri  8 , Ali Khamesipour  9 , Tahmineh Jalali  8 , Mehran Nakhaeizadeh  7 , Hamid Sharifi  2   7 , Yasaman Mansoori  10 , Fariba Keramat  11 , Samad Ghodrati  12   13 , Mostafa Javanian  14 , Delaram Doroud  15 , Mir Davood Omrani  16   17 , Hassan Asadi  17   18 , Mohammad Hassan Pouriayevali  8 , Roya Ghasemian  19 , Hossein Farshidi  20 , Morteza Pourahmad  21 , Iman Ghasemzadeh  22 , Leila Mounesan  1 , Maryam Darvishian  23 , Mohamad Reza Mirjalili  24 , Maria Eugenia Toledo-Romani  25 , Carmen Valenzuela-Silva  26 , Vicente Verez-Bencomo  27 , Mohammad Mehdi Gouya  28   29 , Hamid Emadi-Koochak  30 , Ali Akbar Haghdoost  6 , Alireza Biglari  17   31 ; Soberana Study Group
Collaborators, Affiliations
Clinical Trial

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

Ehsan Mostafavi et al. JAMA Netw Open. .

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 = 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.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Mostafavi is employed by the Pasteur Institute of Iran; he joined Iran's national COVID-19 vaccine committee after the trial's completion. Dr Eybpoosh is employed by the Pasteur Institute of Iran. Dr Salehi-Vaziri is employed by the Pasteur Institute of Iran. Dr Doroud is employed by the Pasteur Institute of Iran. Dr Omrani was the deputy director of the Pasteur Institute of Iran at the time of the study. Mr Asadi is employed by the Pasteur Institute of Iran. Dr Pouriayevali is employed by the Pasteur Institute of Iran. Dr Farshidi became the deputy minister of health and medical education after the trial's completion. Dr Verez-Bencomo reported serving as general director with compensation of the Finlay Vaccine Institute and having a patent pending for WO 2022/073528. Dr Gouya has been the director of the Center for Disease Control of the Ministry of Health of Iran, a members of Iran’s national COVID-19 vaccine, and served as a nonvoting member of the study’s data safety and monitoring board. Dr Biglari is the former director of Pasteur institute of Iran had been the employer of the Pasteur institute of Iran and is a member of the National Committee for the COVID-19 Vaccine. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Trial Profile
Reasons for unmet inclusion criteria in screened participants are reported in eTable 10 in Supplement 2.
Figure 2.
Figure 2.. Cumulative Incidence of COVID-19 Incident Cases (1 – Kaplan-Meier Estimate) in the Primary Analysis Following the First Dose of Vaccine or Placebo in the 2-Dose and 3-Dose Regimens
Figure 3.
Figure 3.. Local and Systemic Adverse Events After Injection of the First, Second, and Third Doses Among Participants Who Received Vaccine or Placebo
AEs indicates adverse events; RR, risk ratio.
See this image and copyright information in PMC

References

    1. Acosta-Coley I, Cervantes-Ceballos L, Tejeda-Benítez L, et al. . Vaccines platforms and COVID-19: what you need to know. Trop Dis Travel Med Vaccines. 2022;8(1):20. doi:10.1186/s40794-022-00176-4 - DOI - PMC - PubMed
    1. Valdes-Balbin Y, Santana-Mederos D, Quintero L, et al. . SARS-CoV-2 RBD-tetanus toxoid conjugate vaccine induces a strong neutralizing immunity in preclinical studies. ACS Chem Biol. 2021;16(7):1223-1233. doi:10.1021/acschembio.1c00272 - DOI - PubMed
    1. Santana-Mederos D, Perez-Nicado R, Climent Y, et al. . A COVID-19 vaccine candidate composed of the SARS-CoV-2 RBD dimer and Neisseria meningitidis outer membrane vesicles. RSC Chem Biol. 2021;3(2):242-249. doi:10.1039/D1CB00200G - DOI - PMC - PubMed
    1. Toledo-Romaní ME, García-Carmenate M, Valenzuela-Silva C, et al. ; Soberana Phase 3 team . Safety and efficacy of the two doses conjugated protein-based Soberana-02 COVID-19 vaccine and of a heterologous three-dose combination with Soberana-Plus: a double-blind, randomised, placebo-controlled phase 3 clinical trial. Lancet Reg Health Am. 2023;18:100423. doi:10.1016/j.lana.2022.100423 - DOI - PMC - PubMed
    1. Toledo-Romani ME, García-Carmenate M, Verdecia-Sánchez L, et al. ; SOBERANA Research Group . Safety and immunogenicity of anti-SARS-CoV-2 heterologous scheme with SOBERANA 02 and SOBERANA Plus vaccines: Phase IIb clinical trial in adults. Med (N Y). 2022;3(11):760-773.e5. doi:10.1016/j.medj.2022.08.001 - DOI - PMC - PubMed

Publication types