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

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...

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Autores principales: Mostafavi, Ehsan, Eybpoosh, Sana, Karamouzian, Mohammad, Khalili, Malahat, Haji-Maghsoudi, Saiedeh, Salehi-Vaziri, Mostafa, Khamesipour, Ali, Jalali, Tahmineh, Nakhaeizadeh, Mehran, Sharifi, Hamid, Mansoori, Yasaman, Keramat, Fariba, Ghodrati, Samad, Javanian, Mostafa, Doroud, Delaram, Omrani, Mir Davood, Asadi, Hassan, Pouriayevali, Mohammad Hassan, Ghasemian, Roya, Farshidi, Hossein, Pourahmad, Morteza, Ghasemzadeh, Iman, Mounesan, Leila, Darvishian, Maryam, Mirjalili, Mohamad Reza, Toledo-Romani, Maria Eugenia, Valenzuela-Silva, Carmen, Verez-Bencomo, Vicente, Gouya, Mohammad Mehdi, Emadi-Koochak, Hamid, Haghdoost, Ali Akbar, Biglari, Alireza
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10157429/
https://www.ncbi.nlm.nih.gov/pubmed/37133864
http://dx.doi.org/10.1001/jamanetworkopen.2023.10302
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author Mostafavi, Ehsan
Eybpoosh, Sana
Karamouzian, Mohammad
Khalili, Malahat
Haji-Maghsoudi, Saiedeh
Salehi-Vaziri, Mostafa
Khamesipour, Ali
Jalali, Tahmineh
Nakhaeizadeh, Mehran
Sharifi, Hamid
Mansoori, Yasaman
Keramat, Fariba
Ghodrati, Samad
Javanian, Mostafa
Doroud, Delaram
Omrani, Mir Davood
Asadi, Hassan
Pouriayevali, Mohammad Hassan
Ghasemian, Roya
Farshidi, Hossein
Pourahmad, Morteza
Ghasemzadeh, Iman
Mounesan, Leila
Darvishian, Maryam
Mirjalili, Mohamad Reza
Toledo-Romani, Maria Eugenia
Valenzuela-Silva, Carmen
Verez-Bencomo, Vicente
Gouya, Mohammad Mehdi
Emadi-Koochak, Hamid
Haghdoost, Ali Akbar
Biglari, Alireza
author_facet Mostafavi, Ehsan
Eybpoosh, Sana
Karamouzian, Mohammad
Khalili, Malahat
Haji-Maghsoudi, Saiedeh
Salehi-Vaziri, Mostafa
Khamesipour, Ali
Jalali, Tahmineh
Nakhaeizadeh, Mehran
Sharifi, Hamid
Mansoori, Yasaman
Keramat, Fariba
Ghodrati, Samad
Javanian, Mostafa
Doroud, Delaram
Omrani, Mir Davood
Asadi, Hassan
Pouriayevali, Mohammad Hassan
Ghasemian, Roya
Farshidi, Hossein
Pourahmad, Morteza
Ghasemzadeh, Iman
Mounesan, Leila
Darvishian, Maryam
Mirjalili, Mohamad Reza
Toledo-Romani, Maria Eugenia
Valenzuela-Silva, Carmen
Verez-Bencomo, Vicente
Gouya, Mohammad Mehdi
Emadi-Koochak, Hamid
Haghdoost, Ali Akbar
Biglari, Alireza
author_sort Mostafavi, Ehsan
collection PubMed
description 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
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spelling pubmed-101574292023-05-05 Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine: A Randomized Clinical Trial Mostafavi, Ehsan Eybpoosh, Sana Karamouzian, Mohammad Khalili, Malahat Haji-Maghsoudi, Saiedeh Salehi-Vaziri, Mostafa Khamesipour, Ali Jalali, Tahmineh Nakhaeizadeh, Mehran Sharifi, Hamid Mansoori, Yasaman Keramat, Fariba Ghodrati, Samad Javanian, Mostafa Doroud, Delaram Omrani, Mir Davood Asadi, Hassan Pouriayevali, Mohammad Hassan Ghasemian, Roya Farshidi, Hossein Pourahmad, Morteza Ghasemzadeh, Iman Mounesan, Leila Darvishian, Maryam Mirjalili, Mohamad Reza Toledo-Romani, Maria Eugenia Valenzuela-Silva, Carmen Verez-Bencomo, Vicente Gouya, Mohammad Mehdi Emadi-Koochak, Hamid Haghdoost, Ali Akbar Biglari, Alireza JAMA Netw Open Original Investigation 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 American Medical Association 2023-05-03 /pmc/articles/PMC10157429/ /pubmed/37133864 http://dx.doi.org/10.1001/jamanetworkopen.2023.10302 Text en Copyright 2023 Mostafavi E et al. JAMA Network Open. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the CC-BY License.
spellingShingle Original Investigation
Mostafavi, Ehsan
Eybpoosh, Sana
Karamouzian, Mohammad
Khalili, Malahat
Haji-Maghsoudi, Saiedeh
Salehi-Vaziri, Mostafa
Khamesipour, Ali
Jalali, Tahmineh
Nakhaeizadeh, Mehran
Sharifi, Hamid
Mansoori, Yasaman
Keramat, Fariba
Ghodrati, Samad
Javanian, Mostafa
Doroud, Delaram
Omrani, Mir Davood
Asadi, Hassan
Pouriayevali, Mohammad Hassan
Ghasemian, Roya
Farshidi, Hossein
Pourahmad, Morteza
Ghasemzadeh, Iman
Mounesan, Leila
Darvishian, Maryam
Mirjalili, Mohamad Reza
Toledo-Romani, Maria Eugenia
Valenzuela-Silva, Carmen
Verez-Bencomo, Vicente
Gouya, Mohammad Mehdi
Emadi-Koochak, Hamid
Haghdoost, Ali Akbar
Biglari, Alireza
Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine: A Randomized Clinical Trial
title Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine: A Randomized Clinical Trial
title_full Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine: A Randomized Clinical Trial
title_fullStr Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine: A Randomized Clinical Trial
title_full_unstemmed Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine: A Randomized Clinical Trial
title_short Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine: A Randomized Clinical Trial
title_sort efficacy and safety of a protein-based sars-cov-2 vaccine: a randomized clinical trial
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10157429/
https://www.ncbi.nlm.nih.gov/pubmed/37133864
http://dx.doi.org/10.1001/jamanetworkopen.2023.10302
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