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8 results on '"Hernández-García, Tays"'

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

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

Published
2023
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2. Safety and immunogenicity of anti-SARS-CoV-2 heterologous scheme with SOBERANA 02 and SOBERANA Plus vaccines: Phase IIb clinical trial in adults

Author

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

Published
2022
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3. Safety and immunogenicity of the FINLAY-FR-1A vaccine in COVID-19 convalescent participants: an open-label phase 2a and double-blind, randomised, placebo-controlled, phase 2b, seamless, clinical trial

Author

Ochoa-Azze, Rolando, Chang-Monteagudo, Arturo, Climent-Ruiz, Yanet, Macías-Abraham, Consuelo, Valenzuela-Silva, Carmen, de los Ángeles García-García, María, Jerez-Barceló, Yanet, Triana-Marrero, Yenisey, Ruiz-Villegas, Laura, Dairon Rodríguez-Prieto, Luis, Guerra-Chaviano, Pedro Pablo, Sánchez-Ramírez, Belinda, Hernández-García, Tays, Orosa-Vázquez, Ivette, Díaz-Hernández, Marianniz, Chiodo, Fabrizio, Calcagno, Andrea, Ghisetti, Valeria, Rodríguez-Acosta, Mireida, Noa-Romero, Enrique, Enríquez-Puertas, Juliet, Ortega-León, Darién, Valdivia-Álvarez, Irinia, Delahanty-Fernández, Aurora, Palenzuela-Díaz, Ariel, Rodríguez-Noda, Laura, González-Mugica, Raúl, Valdés-Balbín, Yury, García-Rivera, Dagmar, and Verez-Bencomo, Vicente

Published
2022
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4. 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

Chang-Monteagudo, Arturo, Ochoa-Azze, Rolando, Climent-Ruiz, Yanet, Macías-Abraham, Consuelo, Rodríguez-Noda, Laura, Valenzuela-Silva, Carmen, Sánchez-Ramírez, Belinda, Perez-Nicado, Rocmira, Hernández-García, Tays, Orosa-Vázquez, Ivette, Díaz-Hernández, Marianniz, García-García, María de los Ángeles, Jerez-Barceló, Yanet, Triana-Marrero, Yenisey, Ruiz-Villegas, Laura, Rodríguez-Prieto, Luis Dairon, Puga-Gómez, Rinaldo, Guerra-Chaviano, Pedro Pablo, Zúñiga-Rosales, Yaíma, Marcheco-Teruel, Beatriz, Rodríguez-Acosta, Mireida, Noa-Romero, Enrique, Enríquez-Puertas, Juliet, Porto-González, Delia, Fernández-Medina, Olivia, Valdés-Zayas, Anet, Chen, Guang-Wu, Herrera-Martínez, Luís, Valdés-Balbín, Yury, García-Rivera, Dagmar, and Verez-Bencomo, Vicente

Published
2021
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5. 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

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

Published
2023
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6. A randomized, double-blind phase I clinical trial of two recombinant dimeric RBD COVID-19 vaccine candidates: Safety, reactogenicity and immunogenicity

Author

Pérez-Rodríguez, Sonia, primary, de la Caridad Rodríguez-González, Meiby, additional, Ochoa-Azze, Rolando, additional, Climent-Ruiz, Yanet, additional, Alberto González-Delgado, Carlos, additional, Paredes-Moreno, Beatriz, additional, Valenzuela-Silva, Carmen, additional, Rodríguez-Noda, Laura, additional, Perez-Nicado, Rocmira, additional, González-Mugica, Raúl, additional, Martínez-Pérez, Marisel, additional, Sánchez-Ramírez, Belinda, additional, Hernández-García, Tays, additional, Díaz-Machado, Alina, additional, Tamayo-Rodríguez, Maura, additional, Martín-Trujillo, Alis, additional, Rubino-Moreno, Jorman, additional, Suárez-Batista, Anamary, additional, Dubed-Echevarría, Marta, additional, Teresa Pérez-Guevara, María, additional, Amoroto-Roig, Mayté, additional, Chappi-Estévez, Yanet, additional, Bergado-Báez, Gretchen, additional, Pi-Estopiñán, Franciscary, additional, Chen, Guang-Wu, additional, Valdés-Balbín, Yury, additional, García-Rivera, Dagmar, additional, and Verez-Bencomo, Vicente, additional

Published
2022
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7. Safety and Immunogenicity of Anti-SARS-CoV-2 Conjugate Vaccine SOBERANA 02: Phase IIb Clinical Trial

Author

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

Published
2022
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8. Safety and immunogenicity of anti-SARS CoV-2 vaccine SOBERANA 02 in homologous or heterologous scheme: Open label phase I and phase IIa clinical trials.

Author

Eugenia-Toledo-Romaní, María, Verdecia-Sánchez, Leslyhana, Rodríguez-González, Meiby, Rodríguez-Noda, Laura, Valenzuela-Silva, Carmen, Paredes-Moreno, Beatriz, Sánchez-Ramírez, Belinda, Pérez-Nicado, Rocmira, González-Mugica, Raul, Hernández-García, Tays, Bergado-Baez, Gretchen, Pi-Estopiñán, Franciscary, Cruz-Sui, Otto, Fraga-Quintero, Anitza, García-Montero, Majela, Palenzuela-Díaz, Ariel, Baró-Román, Gerardo, Mendoza-Hernández, Ivis, Fernandez-Castillo, Sonsire, and Climent-Ruiz, Yanet

Subjects
*IMMUNE response, *SARS-CoV-2 Delta variant, *CONVALESCENT plasma, *SARS-CoV-2, *CLINICAL trials, *VACCINE safety
Abstract

SOBERANA 02 is a COVID-19 vaccine based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid (TT). SOBERANA Plus antigen is dimeric-RBD. Here we report safety and immunogenicity from phase I and IIa clinical trials using two-doses of SOBERANA 02 and three-doses (homologous) or heterologous (with SOBERANA Plus) protocols. We performed an open-label, sequential and adaptive phase I to evaluate safety and explore the immunogenicity of SOBERANA 02 in two formulations (15 or 25 μg RBD-conjugated to 20 μg of TT) in 40 subjects, 19–59-years-old. Phase IIa was open-label including 100 volunteers 19–80-years, receiving two doses of SOBERANA 02–25 μg. In both trials, half of volunteers were selected to receive a third dose of the corresponding SOBERANA 02 and half received a heterologous dose of SOBERANA Plus. Primary outcome was safety. The secondary outcome was immunogenicity evaluated by anti-RBD IgG ELISA, molecular neutralization of RBD:hACE2 interaction, live-virus-neutralization and specific T-cells response. The most frequent adverse event (AE) was local pain, other AEs had frequencies ≤ 5%. No serious related-AEs were reported. Phase IIa confirmed the safety in 60 to 80-years-old subjects. In phase-I SOBERANA 02–25 µg elicited higher immune response than SOBERANA 02–15 µg and progressed to phase IIa. Phase IIa results confirmed the immunogenicity of SOBERANA 02–25 µg even in 60–80-years. Two doses of SOBERANA02-25 µg elicited an immune response similar to that of the Cuban Convalescent Serum Panel and it was higher after the homologous and heterologous third doses. The heterologous scheme showed a higher immunological response. Anti-RBD IgG neutralized the delta variant in molecular assay, with a 2.5-fold reduction compared to D614G neutralization. SOBERANA 02 was safe and immunogenic in persons aged 19–80 years, eliciting neutralizing antibodies and specific T-cell response. Highest immune responses were obtained in the heterologous three doses protocol. Trial registry: https://rpcec.sld.cu/trials/RPCEC00000340 , https://rpcec.sld.cu/trials/RPCEC00000347 [ABSTRACT FROM AUTHOR]

Published
2022
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