Exploratory and open study, to evaluate the safety, reactogenicity and immunogenicity, of a heterologous scheme of two doses of the prophylactic anti SARS vaccine candidate - CoV - 2, FINLAY-FR-2 and one dose of FINLAY-FR-1A, in Cuban children and adolescents (COVID-19) - SOBERANA PEDIATRIA CLINICA 1

Start Date17 Jul 2021

Sponsor / Collaborator-

RPCEC00000354

/ CompletedPhase 3IIT

Phase III clinical trial, multicenter, adaptive, parallel-group, randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety and immunogenicity of vaccination against SARS-CoV-2 with 2 doses of FINLAY-FR-2 and a heterologous scheme with 2 doses of FINLAY-FR-2 and a booster dose with FINLAY-FR-1A (COVID-19) - SOBERANA 02-Fase III

Start Date08 Mar 2021

Sponsor / Collaborator

Finlay Vaccine Institute

100 Clinical Results associated with FINLAY-FR2 anti-SARS-CoV-2 Vaccine(Finlay Vaccine Institute)

100 Translational Medicine associated with FINLAY-FR2 anti-SARS-CoV-2 Vaccine(Finlay Vaccine Institute)

100 Patents (Medical) associated with FINLAY-FR2 anti-SARS-CoV-2 Vaccine(Finlay Vaccine Institute)

Literatures (Medical) associated with FINLAY-FR2 anti-SARS-CoV-2 Vaccine(Finlay Vaccine Institute)

01 May 2023·JAMA network open

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

Article

Author: Ghasemzadeh, Iman ; Mounesan, Leila ; Mirjalili, Mohamad Reza ; Nakhaeizadeh, Mehran ; Farshidi, Hossein ; Emadi-Koochak, Hamid ; Darvishian, Maryam ; Biglari, Alireza ; Ghodrati, Samad ; Jalali, Tahmineh ; Pouriayevali, Mohammad Hassan ; Haghdoost, Ali Akbar ; Toledo-Romani, Maria Eugenia ; Keramat, Fariba ; Mostafavi, Ehsan ; Valenzuela-Silva, Carmen ; Eybpoosh, Sana ; Doroud, Delaram ; Javanian, Mostafa ; Pourahmad, Morteza ; Haji-Maghsoudi, Saiedeh ; Khalili, Malahat ; Salehi-Vaziri, Mostafa ; Karamouzian, Mohammad ; Asadi, Hassan ; Ghasemian, Roya ; Mansoori, Yasaman ; Omrani, Mir Davood ; Khamesipour, Ali ; Sharifi, Hamid ; Gouya, Mohammad Mehdi ; Verez-Bencomo, Vicente

ImportanceThe 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.ObjectiveTo 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 ParticipantsA 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.InterventionsIn 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 MeasuresThe 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.ResultsIn 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 RelevanceIn 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 Registrationisrctn.org Identifier: IRCT20210303050558N1.

01 Jan 2023·International Journal of Infectious Diseases

Open-label phase I/II clinical trial of SARS-CoV-2 receptor binding domain-tetanus toxoid conjugate vaccine (FINLAY-FR-2) in combination with receptor binding domain-protein vaccine (FINLAY-FR-1A) in children

Article

Author: Valenzuela-Silva, Carmen ; Santana-Mederos, Darielys ; Valdés-Balbín, Yury ; Pérez, Noelvia Pestana ; Echevarría, Martha Dubet ; Climent-Ruiz, Yanet ; Chappi-Estévez, Yanet ; Céspedes-Henriquez, Leyanis ; García-Vega, Yanelda ; Enriquez-Puertas, Juliet María ; Infante-Hernández, Yenicet ; Gato-Orozco, Evelyn ; Biglari, Alireza ; Fundora-Barrios, Talía ; Pérez-Nicado, Rocmira ; Rojas-Iriarte, Chaumey ; Piedra-Bello, Misleidys ; Puga-Gómez, Rinaldo ; Toledo-Romani, María Eugenia ; Suarez-Martinez, Miladi ; Hernández-García, Tays ; Paredes-Moreno, Beatriz ; Vérez-Bencomo, Vicente ; Rodríguez-González, Meiby ; González-Mugica, Raul ; Ricardo-Delgado, Yariset ; García-Rivera, Dagmar ; Palenzuela-Díaz, Ariel ; Fernandez-Castillo, Sonsire ; Vega-Mendoza, Dania ; Rodríguez-Noda, Laura ; Castillo-Quintana, Ismavy C ; Doroud, Delaram ; Francisco-Pérez, Julio Cesar ; Sánchez-Ramírez, Belinda

OBJECTIVESTo evaluate a heterologous vaccination scheme in children 3-18 years old (y/o) combining two SARS-CoV-2r- receptor binding domain (RBD)protein vaccines.METHODSA phase I/II open-label, adaptive, and multicenter trial evaluated the safety and immunogenicity of two doses of FINLAY-FR-2 (subsequently called SOBERANA 02) and the third heterologous dose of FINLAY-FR-1A (subsequently called SOBERANA Plus) in 350 children 3-18 y/o in Havana Cuba. Primary outcomes were safety (phase I) and safety/immunogenicity (phase II) measured by anti-RBD immunoglobulin (Ig)G enzyme-linked immunoassay (ELISA), molecular and live-virus neutralization titers, and specific T-cells response. A comparison with adult immunogenicity and predictions of efficacy were made based on immunological results.RESULTSLocal pain was the unique adverse event with frequency >10%, and none was serious neither severe. Two doses of FINLAY-FR-2 elicited a humoral immune response similar to natural infection; the third dose with FINLAY-FR-1A increased the response in all children, similar to that achieved in vaccinated young adults. The geometric mean (GMT) neutralizing titer was 173.8 (95% confidence interval [CI] 131.7; 229.5) vs Alpha, 142 (95% CI 101.3; 198.9) vs Delta, 24.8 (95% CI 16.8; 36.6) vs Beta and 99.2 (95% CI 67.8; 145.4) vs Omicron.CONCLUSIONThe heterologous scheme was safe and immunogenic in children 3-18 y/o.TRIAL REGISTRYhttps://rpcec.sld.cu/trials/RPCEC00000374.

01 Nov 2022·Med

Safety and immunogenicity of anti-SARS-CoV-2 heterologous scheme with SOBERANA 02 and SOBERANA Plus vaccines: Phase IIb clinical trial in adults

Article

Author: Valenzuela-Silva, Carmen ; Vérez-Bencomo, Vicente ; Palenzuela-Diaz, Ariel ; Paredes-Moreno, Beatriz ; Climent-Ruiz, Yanet ; Espi-Ávila, Jennifer ; Espino-Rojas, Niurka Tamara ; Rodriguez-González, Meybis ; Ramírez-Gonzalez, Ubel ; Coviella-Artime, José Manuel ; Ontivero-Pino, Ivis ; Medinas-Santos, Gloria Margarita ; Acosta-Martinez, Mario Alejandro ; Dubed-Echevarría, Marta ; Morffi-Cinta, Irania ; Chen, Guang-Wu ; Perez-Perez, Alina ; Pérez-Rodríguez, Suzel ; Reyes-Matienzo, Radamet ; Mendoza-Hernández, Ivis ; Martínez-Pérez, Marisel ; Arteaga-García, Amaylid ; Fontanies-Fernández, Marcos ; Valera-Fernández, Rodrigo ; Boggiano-Ayo, Tammy ; Galano-Frutos, Evelyn ; Enriquez-Puertas, Juliet ; Quintero-Moreno, Lauren ; Muñoz, Yaima ; Hernández-Garcia, Tays ; Acevedo-Martínez, Yosmel ; Orosa-Vázquez, Ivette ; Rodríguez, Misladys ; Rivera, Daniel G. ; Bergado-Baez, Gretchen ; Santana-Mederos, Darielys ; Garrido-Arteaga, Raine ; Noa-Romero, Enrique ; Garcés-Hechavarría, Aniurka ; Baro-Roman, Gerardo ; Doroud, Delaram ; Domínguez-Pentón, Yeney Regla ; Morales-Ruano, Susana ; Estoque-Cabrera, Solangel ; García-López, Elena ; Pi-Estopiñán, Franciscary ; Rodríguez-Castillo, Pedro Gabriel ; Cruz-Sui, Otto ; Alfaro-Guzmán, Ainadis ; Gómez-Maceo, Yanet ; García-Montero, Majela ; González-Mugica, Raúl ; Verdecia-Sánchez, Leslyhana ; Lora-García, Janet ; Cardoso-SanJorge, Félix ; Sanchez-Ramirez, Belinda ; García-Rivera, Dagmar ; Santos-Vega, Bertha Leysi ; Díaz-Hernández, Marianniz ; Ojito-Magaz, Eduardo ; Toledo-Romani, María Eugenia ; García-Carmenate, Mayra ; Pérez-Guevara, María Teresa ; Rodríguez-Noda, Laura ; Valdés-Balbín, Yury ; Fernandez-Castillo, Sonsire ; Brito-Pascual, Idalmis ; Zulueta-Pérez, Lilian ; Amoroto, Maité ; Medina-Nápoles, Maite ; Biglari, Alireza ; Martínez-Bedoya, Dayle ; García-Vega, Yanelda ; Ávila-Cabreja, José Alejandro ; Martínez-Rivera, Roselyn ; Sarda-Rodriguez, Ileana Luisa ; Cubas-Curbelo, Mailin ; Guillén-Obregón, Berta

BACKGROUNDSOBERANA 02 has been evaluated in phase I and IIa studies comparing homologous versus heterologous schedule (this one, including SOBERANA Plus). Here, we report results of immunogenicity, safety, and reactogenicity of SOBERANA 02 in a two- or three-dose heterologous scheme in adults.METHODPhase IIb was a parallel, multicenter, adaptive, double-blind, randomized, and placebo-controlled trial. Subjects (n = 810) aged 19-80 years were randomized to receive two doses of SARS-CoV-2 RBD conjugated to tetanus toxoid (SOBERANA 02) and a third dose of dimeric RBD (SOBERANA Plus) 28 days apart; two production batches of active ingredients of SOBERANA 02 were evaluated. Primary outcome was the percentage of seroconverted subjects with ≥4-fold the anti-RBD immunoglobulin G (IgG) concentration. Secondary outcomes were safety, reactogenicity, and neutralizing antibodies.FINDINGSSeroconversion rate in vaccinees was 76.3% after two doses and 96.8% after the third dose of SOBERANA Plus (7.3% in the placebo group). Neutralizing IgG antibodies were detected against D614G and variants of concern (VOCs) Alpha, Beta, Delta, and Omicron. Specific, functional antibodies were detected 7-8 months after the third dose. The frequency of serious adverse events (AEs) associated with vaccination was very low (0.1%). Local pain was the most frequent AE.CONCLUSIONSTwo doses of SOBERANA 02 were safe and immunogenic in adults. The heterologous combination with SOBERANA Plus increased neutralizing antibodies, detectable 7-8 months after the third dose.TRIAL REGISTRYhttps://rpcec.sld.cu/trials/RPCEC00000347 FUNDING: This work was supported by Finlay Vaccine Institute, BioCubaFarma, and the Fondo Nacional de Ciencia y Técnica (FONCI-CITMA-Cuba, contract 2020-20).

100 Deals associated with FINLAY-FR2 anti-SARS-CoV-2 Vaccine(Finlay Vaccine Institute)

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Indication	Highest Phase	Country/Location	Organization	Date
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