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

RPCEC00000340

/ CompletedPhase 1IIT

Phase I study, open, sequential and adaptive for evaluating the safety, reactogenicity and explore the immunogenicity of the prophylactic Vaccine Candidate FINLAY-FR-2 anti SARS-CoV-2 (COVID-19) - SOBERANA 02

Start Date02 Nov 2020

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 ; Fundora-Barrios, Talía ; Biglari, Alireza ; 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 ; Dubed-Echevarría, Marta ; Acosta-Martinez, Mario Alejandro ; Morffi-Cinta, Irania ; Chen, Guang-Wu ; Perez-Perez, Alina ; Pérez-Rodríguez, Suzel ; Mendoza-Hernández, Ivis ; Reyes-Matienzo, Radamet ; 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 ; Morales-Ruano, Susana ; Domínguez-Pentón, Yeney Regla ; 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 ; Toledo-Romani, María Eugenia ; Díaz-Hernández, Marianniz ; Ojito-Magaz, Eduardo ; Santos-Vega, Bertha Leysi ; 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)

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	Cuba	Finlay Vaccine Institute	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis


No Data

FINLAY-FR2 anti-SARS-CoV-2 Vaccine(Finlay Vaccine Institute)

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation