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1. 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

Author

Rinaldo Puga-Gómez, Yariset Ricardo-Delgado, Chaumey Rojas-Iriarte, Leyanis Céspedes-Henriquez, Misleidys Piedra-Bello, Dania Vega-Mendoza, Noelvia Pestana Pérez, Beatriz Paredes-Moreno, Meiby Rodríguez-González, Carmen Valenzuela-Silva, Belinda Sánchez-Ramírez, Laura Rodríguez-Noda, Rocmira Pérez-Nicado, Raul González-Mugica, Tays Hernández-García, Talía Fundora-Barrios, Martha Dubet Echevarría, Juliet María Enriquez-Puertas, Yenicet Infante-Hernández, Ariel Palenzuela-Díaz, Evelyn Gato-Orozco, Yanet Chappi-Estévez, Julio Cesar Francisco-Pérez, Miladi Suarez-Martinez, Ismavy C. Castillo-Quintana, Sonsire Fernandez-Castillo, Yanet Climent-Ruiz, Darielys Santana-Mederos, Yanelda García-Vega, María Eugenia Toledo-Romani, Delaram Doroud, Alireza Biglari, Yury Valdés-Balbín, Dagmar García-Rivera, Vicente Vérez-Bencomo, María Elena Mesa-Herrera, Yarmila García-Cristiá, Leonor Verdecia-Sánchez, Rafael del Valle Rodríguez, Yudalvies Oquendo-de la Cruz, Daysi Álvarez-Montalvo, Randy Grillo-Fortún, Liset López-González, Omaida Fonte Galindo, Yeseni Reyes-González, Ana Beatriz González-Álvarez, Linet Gorrita-Mora, Rodrigo Valera-Fernández, Ivis Ontivero-Pino, Marisel Martínez-Pérez, Esperanza Caballero-Gonzalez, Aniurka Garcés-Hechavarría, Dayle Martínez-Bedoya, Maite Medina-Nápoles, Yeney Regla Domínguez-Pentón, Yadira Cazañas-Quintana, Thais Fundora Barrios, Diana R. Hernández Fernández, Gretchen Bergado-Báez, Ivette Orosa-Vazquez, Franciscary Pi-Estopiñan, Marianniz Díaz-Hernández, Otto Cruz-Sui, Enrique Noa-Romero, Arilia García-López, Sandra Rivadereira Muro, and Gerardo Baro-Roman

Subjects
Microbiology (medical), Infectious Diseases, General Medicine
Published
2023
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2. Safety and Immunogenicity of Anti-SARS-CoV-2 Conjugate Vaccine SOBERANA 02: Phase IIb Clinical Trial

Author

Maria Eugenia-Toledo-Romani, Mayra García Carmenate, Leslyhana Verdecia-Sánchez, Suzel Pérez-Rodríguez, Meiby Rodriguez-González, Carmen Valenzuela-Silva, Beatriz Paredes-Moreno, Belinda Sánchez-Ramírez, Raul González-Mugica, Tays Hernández-García, Ivette Orosa-Vázquez, Marianniz Díaz-Hernández, María Teresa Pérez-Guevara, Juliet Enríquez-Puertas, Enrique Noa-Romero, Ariel Palenzuela-Diaz, Gerardo Baro-Roman, Ivis Mendoza-Hernández, Yaima Muñoz, Yanet Gómez-Maceo, Bertha Leysi Santos Vega, Sonsire Fernandez-Castillo, Yanet Climent-Ruiz, Laura Rodríguez-Noda, Darielys Santana-Mederos, Yanelda García-Vega, Guang Wu-Chen, Delaram Doroud, Alireza Biglari, Tammy Boggiano-Ayo, Yury Valdés-Balbín, Daniel G. Rivera, Dagmar García-Rivera, Vicente Verez-Bencomo, and SOBERANA Research Group

Published
2022
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3. Safety and immunogenicity of anti-SARS-CoV-2 heterologous scheme with SOBERANA 02 and SOBERANA Plus vaccines: Phase IIb clinical trial in adults

Author

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

Subjects
Adult, Vaccines, SARS-CoV-2, Immunoglobulin G, Humans, COVID-19, General Medicine, Antibodies, Neutralizing
Abstract

SOBERANA 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.Phase 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.Seroconversion 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.Two 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.https://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).

Published
2022
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4. A COVID-19 vaccine candidate composed of the SARS-CoV-2 RBD dimer and

Author

Darielys, Santana-Mederos, Rocmira, Perez-Nicado, Yanet, Climent, Laura, Rodriguez, Belinda Sanchez, Ramirez, Sonia, Perez-Rodriguez, Meybi, Rodriguez, Claudia, Labrada, Tays, Hernandez, Marianniz, Diaz, Ivette, Orosa, Ubel, Ramirez, Reynaldo, Oliva, Raine, Garrido, Felix, Cardoso, Mario, Landys, Roselyn, Martinez, Humberto, Gonzalez, Tamara, Hernandez, Rolando, Ochoa-Azze, Jose L, Perez, Juliet, Enriquez, Nibaldo, Gonzalez, Yenicet, Infante, Luis A, Espinosa, Yassel, Ramos, Luis Javier, González, Carmen, Valenzuela, Ana Victoria, Casadesus, Briandy, Fernandez, Gertrudis, Rojas, Beatriz, Pérez-Massón, Yaima, Tundidor, Ernesto, Bermudez, Claudia A, Plasencia, Tammy, Boggiano, Eduardo, Ojito, Fabrizio, Chiodo, Sonsire, Fernandez, Françoise, Paquet, Cheng, Fang, Guang-Wu, Chen, Daniel G, Rivera, Yury, Valdes-Balbin, Dagmar, Garcia-Rivera, and Vicente, Verez Bencomo

Abstract

SARS-CoV-2 infection is mediated by the interaction of the spike glycoprotein trimer

Published
2021

5. A single dose of SARS-CoV-2 FINLAY-FR-1A dimeric-RBD recombinant vaccine enhances neutralization response in COVID-19 convalescents, with excellent safety profile. A preliminary report of an open-label phase 1 clinical trial

Author

Vicente Verez-Bencomo, Kalet Leon-Monzon, Yaima Zuniga-Rosales, Yanet Jerez-Barcelo, Yury Valdés-Balbín, Carmen Valenzuela-Silva, Marianniz Diaz-Hernandez, Yanet Climent-Ruiz, Juliet Enriquez-Puertas, Maria de los A. Garcia-Garcia, Delia Porto-Gonzalez, Raul Gonzalez-Mugica, Dagmar García-Rivera, Belinda Sanchez-Ramirez, Rocmira Perez-Nicado, Guang-Wu Chen, Pedro Pablo Guerra-Chaviano, Luis Herrera Martinez, Mireida Rodriguez-Acosta, Arturo Chang-Monteagudo, Tays Hernandez-Garcia, Rolando Ochoa-Azze, Rinaldo Puga-Gomez, Luis Dairon Rodríguez-Prieto, Ivette Orosa-Vazquez, Laura Ruiz-Villegas, Yenisey Triana-Marrero, Enrique Noa-Romero, Beatriz Marcheco-Teruel, Consuelo Macías-Abraham, and Laura M. Rodríguez-Noda

Subjects
Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Phases of clinical research, Virology, Neutralization, law.invention, Vaccination, Safety profile, Preliminary report, law, Recombinant DNA, Medicine, business
Abstract

We evaluated response to a single dose of the FINLAY-FR-1A recombinant dimeric-RBD base vaccine during a phase I clinical trial with 30 COVID-19 convalescents, to test its capacity for boosting natural immunity. This short report shows: a) an excellent safety profile one month after vaccination for all participants, similar to that previously found during vaccination of naïve individuals; b) a single dose of vaccine induces a >20 fold increase in antibody response one week after vaccination and remarkably 4-fold higher virus neutralization compared to the median obtained for Cuban convalescent serum panel. These preliminary results prompt initiation of a phase II trial in order to establish a general vaccination protocol for convalescents.

Published
2021
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6. A single dose of SARS-CoV-2 FINLAY-FR-1A vaccine enhances neutralization response in COVID-19 convalescents, with a very good safety profile: An open-label phase 1 clinical trial

Author

Delia Porto-Gonzalez, Dagmar García-Rivera, Laura M. Rodríguez-Noda, Marianniz Diaz-Hernandez, Yanet Climent-Ruiz, Vicente Verez-Bencomo, Mireida Rodriguez-Acosta, Enrique Noa-Romero, Belinda Sanchez-Ramirez, Arturo Chang-Monteagudo, Pedro Pablo Guerra-Chaviano, Rolando Ochoa-Azze, Carmen Valenzuela-Silva, Olivia Fernández-Medina, Anet Valdes-Zayas, Yanet Jerez-Barcelo, Tays Hernandez-Garcia, Rocmira Perez-Nicado, Beatriz Marcheco-Teruel, Yenisey Triana-Marrero, Guang-Wu Chen, Laura Ruiz-Villegas, Rinaldo Puga-Gomez, Luis Dairon Rodríguez-Prieto, Maria de los A. Garcia-Garcia, Consuelo Macías-Abraham, Yury Valdés-Balbín, Juliet Enriquez-Puertas, Ivette Orosa-Vazquez, Yaíma Zúñiga-Rosales, and Luis Herrera-Martínez

Subjects
Gynecology, medicine.medical_specialty, Reactogenicity, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Phases of clinical research, Article, Neutralization, Vaccination, Safety profile, Medicine, Public aspects of medicine, RA1-1270, Open label, business
Abstract

Background: As a first step towards a vaccine protecting COVID-19 convalescents from reinfection, we evaluated FINLAY-FR-1A vaccine in a clinical trial. Methods: Thirty COVID-19 convalescents aged 22-57 years were studied: convalescents of mild COVID-19, asymptomatic convalescents, both with PCR-positive at the moment of diagnosis; and individuals with subclinical infection detected by viral-specific IgG. They received a single intramuscular injection of the FINLAY-FR-1A vaccine (50 µg of the recombinant dimeric receptor binding domain). The primary outcomes were safety and reactogenicity, assessed over 28 days after vaccination. The secondary outcome was vaccine immunogenicity. Humoral response at baseline and following vaccination was evaluated by ELISA and live-virus neutralization test. The effector T cellular response was also assessed. Cuban Public Registry of Clinical Trials, WHO-ICTRP: https://rpcec.sld.cu/en/trials/RPCEC00000349-En. Findings: No serious adverse events were reported. Minor adverse events were found, the most common, local pain: 3 (10%) and redness: 2 (6·7%). The vaccine elicited a >21 fold increase in IgG anti-RBD antibodies 28 days after vaccination. The median of inhibitory antibody titres (94·0%) was three times greater than that of the COVID-19 convalescent panel. Virus neutralization titres higher than 1:160 were found in 24 (80%) participants. There was also an increase in RBD-specific T cells producing IFN-I³ and TNF-α. Interpretation: A single dose of the FINLAY-FR-1A vaccine against SARS-CoV-2 was an efficient booster of pre-existing natural immunity, with excellent safety profile. Funding: Partial funding for this study was received from the Project-2020-20, Fondo de Ciencia e Innovacion (FONCI), Ministry of Science, Technology and the Environment, Cuba.   RESUMEN. Antecedentes: Como un primer paso hacia una vacuna que proteja a los convalecientes de COVID-19 de la reinfeccion, evaluamos la vacuna FINLAY-FR-1A en un ensayo clinico. Metodos: Se estudiaron treinta convalecientes de COVID-19 de 22 a 57 anos: convalecientes de COVID-19 leve y convalecientes asintomaticos, ambos con prueba PCR positiva al momento del diagnostico; e individuos con infeccion subclinica detectada por IgG especifica viral. Los participantes recibieron una dosis unica por via intramuscular de la vacuna FINLAY-FR-1A (50 µg del dominio de union al receptor recombinante dimerico del SARS CoV-2). Las variables de medida primarias fueron la seguridad y la reactogenicidad, evaluadas durante 28 dias despues de la vacunacion. La variable secundaria, la inmunogenicidad. La respuesta humoral, al inicio del estudio y despues de la vacunacion, se evaluo por ELISA y mediante la prueba de neutralizacion del virus vivo. Tambien se evaluo la respuesta de celulas T efectoras. Registro Publico Cubano de Ensayos Clinicos, WHO-ICTRP: https://rpcec.sld.cu/en/trials/RPCEC00000349-En. Resultados: No se reportaron eventos adversos graves. Se encontraron eventos adversos leves, los mas comunes, dolor local: 3 (10%) y enrojecimiento: 2 (6·7%). La vacuna estimulo un incremento >21 veces de los anticuerpos IgG anti-RBD 28 dias despues de la vacunacion. La mediana de los titulos de anticuerpos inhibidores (94·0%) fue aproximadamente tres veces mayor que la del panel de convalecientes de COVID-19. Se encontraron titulos de neutralizacion viral superiores a 1:160 en 24 (80%) de los participantes. Tambien hubo un aumento en las celulas T especificas de RBD que producen IFN-I³ y TNF-α. Interpretacion: Una sola dosis de la vacuna FINLAY-FR-1A contra el SARS-CoV-2 reforzo eficazmente la inmunidad natural preexistente, con un excelente perfil de seguridad. Financiamiento: Se recibio un financiamiento parcial del Proyecto-2020-20, Fondo de Ciencia e Innovacion (FONCI), Ministerio de Ciencia, Tecnologia y Medio Ambiente, Cuba.

Published
2021
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