13 results on '"Paredes-Moreno, Beatriz"'
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2. 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
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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
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- 2023
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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
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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
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- 2022
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4. Comparative Immune Response after Vaccination with SOBERANA® 02 and SOBERANA® plus Heterologous Scheme and Natural Infection in Young Children
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Pérez-Nicado, Rocmira, primary, Massa, Chiara, additional, Rodríguez-Noda, Laura Marta, additional, Müller, Anja, additional, Puga-Gómez, Rinaldo, additional, Ricardo-Delgado, Yariset, additional, Paredes-Moreno, Beatriz, additional, Rodríguez-González, Meiby, additional, García-Ferrer, Marylé, additional, Palmero-Álvarez, Ilianet, additional, Garcés-Hechavarría, Aniurka, additional, Rivera, Daniel G., additional, Valdés-Balbín, Yury, additional, Vérez-Bencomo, Vicente, additional, García-Rivera, Dagmar, additional, and Seliger, Barbara, additional
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- 2023
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5. Comparative Immune Response after Vaccination with SOBERANA ® 02 and SOBERANA ® plus Heterologous Scheme and Natural Infection in Young Children.
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Pérez-Nicado, Rocmira, Massa, Chiara, Rodríguez-Noda, Laura Marta, Müller, Anja, Puga-Gómez, Rinaldo, Ricardo-Delgado, Yariset, Paredes-Moreno, Beatriz, Rodríguez-González, Meiby, García-Ferrer, Marylé, Palmero-Álvarez, Ilianet, Garcés-Hechavarría, Aniurka, Rivera, Daniel G., Valdés-Balbín, Yury, Vérez-Bencomo, Vicente, García-Rivera, Dagmar, and Seliger, Barbara
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MULTISYSTEM inflammatory syndrome ,IMMUNE response ,VACCINE effectiveness ,IMMUNOLOGIC memory ,VACCINATION of children ,GRANZYMES ,BACTERIAL vaccines - Abstract
(1) Background: In children, SARS-CoV-2 infection is mostly accompanied by mild COVID-19 symptoms. However, multisystem inflammatory syndrome (MIS-C) and long-term sequelae are often severe complications. Therefore, the protection of the pediatric population against SARS-CoV-2 with effective vaccines is particularly important. Here, we compare the humoral and cellular immune responses elicited in children (n = 15, aged 5–11 years) vaccinated with the RBD-based vaccines SOBERANA
® 02 and SOBERANA® Plus combined in a heterologous scheme with those from children (n = 10, aged 4–11 years) who recovered from mild symptomatic COVID-19. (2) Methods: Blood samples were taken 14 days after the last dose for vaccinated children and 45–60 days after the infection diagnosis for COVID-19 recovered children. Anti-RBD IgG and ACE2-RBD inhibition were assessed by ELISA; IgA, cytokines, and cytotoxic-related proteins were determined by multiplex assays. Total B and T cell subpopulations and IFN-γ release were measured by multiparametric flow cytometry using a large panel of antibodies after in vitro stimulation with S1 peptides. (3) Results: Significant higher levels of specific anti-RBD IgG and IgA and ACE2-RBD inhibition capacity were found in vaccinated children in comparison to COVID-19 recovered children. Th1-like and Th2-like CD4+ T cells were also significantly higher in vaccinated subjects. IFN-γ secretion was higher in central memory CD4+ T cells of COVID-19 recovered children, but no differences between both groups were found in the CD4+ and CD8+ T cell effector, terminal effector, and naïve T cell subpopulations. In contrast to low levels of IL-4, high levels of IL-2, IL-6, IFN-γ, and IL-10 suggest a predominant Th1 cell polarization. Cytotoxic-related proteins granzyme A and B, perforin, and granulin were also found in the supernatant after S1 stimulation in both vaccinated and recovered children. (4) Conclusions: Vaccination with the heterologous scheme of SOBERANA® 02/SOBERANA® Plus induces a stronger antibody and cellular immune response compared to natural infections in young children. [ABSTRACT FROM AUTHOR]- Published
- 2023
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6. 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
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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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7. Safety and immunogenicity of anti-SARS-CoV-2 heterologous scheme with SOBERANA 02 and SOBERANA Plus vaccines: Phase IIb clinical trial in adults
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Toledo-Romani, María Eugenia, primary, García-Carmenate, Mayra, additional, Verdecia-Sánchez, Leslyhana, additional, Pérez-Rodríguez, Suzel, additional, Rodriguez-González, Meybis, additional, Valenzuela-Silva, Carmen, additional, Paredes-Moreno, Beatriz, additional, Sanchez-Ramirez, Belinda, additional, González-Mugica, Raúl, additional, Hernández-Garcia, Tays, additional, Orosa-Vázquez, Ivette, additional, Díaz-Hernández, Marianniz, additional, Pérez-Guevara, María Teresa, additional, Enriquez-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, Chen, Guang-Wu, additional, Doroud, Delaram, additional, Biglari, Alireza, additional, Boggiano-Ayo, Tammy, additional, Valdés-Balbín, Yury, additional, Rivera, Daniel G., additional, García-Rivera, Dagmar, additional, Vérez-Bencomo, Vicente, additional, Cubas-Curbelo, Mailin, additional, Rodríguez-Castillo, Pedro Gabriel, additional, Acevedo-Martínez, Yosmel, additional, Estoque-Cabrera, Solangel, additional, Ávila-Cabreja, José Alejandro, additional, Alfaro-Guzmán, Ainadis, additional, Zulueta-Pérez, Lilian, additional, Espino-Rojas, Niurka Tamara, additional, Medinas-Santos, Gloria Margarita, additional, Sarda-Rodriguez, Ileana Luisa, additional, Acosta-Martinez, Mario Alejandro, additional, Reyes-Matienzo, Radamet, additional, Coviella-Artime, José Manuel, additional, Morffi-Cinta, Irania, additional, Martínez-Pérez, Marisel, additional, Valera-Fernández, Rodrigo, additional, Garcés-Hechavarría, Aniurka, additional, Martínez-Bedoya, Dayle, additional, Garrido-Arteaga, Raine, additional, Cardoso-SanJorge, Félix, additional, Ramírez-Gonzalez, Ubel, additional, Quintero-Moreno, Lauren, additional, Ontivero-Pino, Ivis, additional, Martínez-Rivera, Roselyn, additional, Guillén-Obregón, Berta, additional, Lora-García, Janet, additional, Medina-Nápoles, Maite, additional, Espi-Ávila, Jennifer, additional, Fontanies-Fernández, Marcos, additional, Domínguez-Pentón, Yeney Regla, additional, Bergado-Baez, Gretchen, additional, Pi-Estopiñán, Franciscary, additional, Ojito-Magaz, Eduardo, additional, Rodríguez, Misladys, additional, Cruz-Sui, Otto, additional, García-Montero, Majela, additional, Dubed-Echevarría, Marta, additional, García-López, Elena, additional, Galano-Frutos, Evelyn, additional, Perez-Perez, Alina, additional, Morales-Ruano, Susana, additional, Brito-Pascual, Idalmis, additional, Amoroto, Maité, additional, and Arteaga-García, Amaylid, additional
- Published
- 2022
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8. A randomized, double-blind phase I clinical trial of two recombinant dimeric RBD COVID-19 vaccine candidates: Safety, reactogenicity and immunogenicity
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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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9. Safety and Immunogenicity of Anti-SARS-CoV-2 Conjugate Vaccine SOBERANA 02: Phase IIb Clinical Trial
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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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10. Safety and Efficacy of the Two Doses Conjugated Protein-Based SOBERANA-02 COVID-19 Vaccine and of a Heterologous Three-Dose Combination with SOBERANA-PLUS: Double-Blind, Randomised, Placebo-Controlled Phase 3 Clinical Trial
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Eugenia-Toledo-Romani, Maria, primary, García Carmenate, Mayra, additional, Valenzuela-Silva, Carmen, additional, Baldoquín-Rodríguez, Waldemar, additional, Martínez-Pérez, Marisel, additional, Rodriguez-González, Meiby, additional, Paredes-Moreno, Beatriz, additional, Mendoza-Hernández, Ivis, additional, González-Mugica, Raul, additional, Samón-Tabío, Oscar, additional, Velazco-Villares, Pablo, additional, Bacallao-Castillo, Juan Pablo, additional, Licea-Martín, Ernesto, additional, Rodríguez-Ortega, Misladys, additional, Herrera-Marrero, Nuris, additional, Caballero-González, Esperanza, additional, Egües-Torres, Liudmila, additional, Duartes-González, Reinaldo, additional, García-Blanco, Serguey, additional, Pérez-Cabrera, Suzette Pérez-Cabrera, additional, Huete-Ferreira, Santos, additional, Idalmis-Cisnero, Kirenia Idalmis-Cisnero, additional, Fonte-Galindo, Omayda, additional, Melia-Pérez, Dania, additional, Rojas-Remedios, Ivonne, additional, Doroud, Delaram, additional, Mehdi Gouya, Mohammad, additional, Biglari, Alireza, additional, Van der Stuyft, Patrick Van der Stuyft, additional, Fernandez-Castillo, Sonsire, additional, Climent-Ruiz, Yanet, additional, Valdés-Balbín, Yury, additional, García-Rivera, Dagmar, additional, and Verez-Bencomo, Vicente, additional
- Published
- 2022
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11. A randomized, double-blind phase I clinical trial of two recombinant dimeric RBD COVID-19 vaccine candidates: safety, reactogenicity and immunogenicity
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Perez-Rodriguez, Sonia, primary, Rodriguez-Gonzalez, Meiby de la Caridad, additional, Ochoa-Azze, Rolando, additional, Climent-Ruiz, Yanet, additional, Gonzalez-Delgado, Carlos Alberto, additional, Paredes-Moreno, Beatriz, additional, Valenzuela-Silva, Carmen, additional, Rodriguez-Noda, Laura, additional, Perez-Nicado, Rocmira, additional, Gonzalez-Mugica, Raul, additional, Martinez-Perez, Marisel, additional, Sanchez-Ramirez, Belinda, additional, Hernandez-Garcia, Tays, additional, Diaz-Machado, Alina, additional, Tamayo-Rodriguez, Maura, additional, Martin-Trujillo, Alis, additional, Rubino-Moreno, Jorman, additional, Suarez-Batista, Anamary, additional, Dubed-Echevarria, Marta, additional, Perez-Guevara, Maria Teresa, additional, Amoroto-Roig, Mayte, additional, Chappi-Estevez, Yanet, additional, Bergado-Baez, Gretchen, additional, Pi-Estopinan, Franciscary, additional, Chen, Guang-Wu, additional, Valdes-Balbin, Yury, additional, Garcia-Rivera, Dagmar, additional, and Verez-Bencomo, Vicente, additional
- Published
- 2021
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12. Safety and efficacy of the two doses conjugated protein-based SOBERANA-02 COVID-19 vaccine and of a heterologous three-dose combination with SOBERANA-Plus: a double-blind, randomised, placebo-controlled phase 3 clinical trial
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Toledo-Romaní, María Eugenia, García-Carmenate, Mayra, Valenzuela-Silva, Carmen, Baldoquín-Rodríguez, Waldemar, Martínez-Pérez, Marisel, Rodríguez-González, Meiby, Paredes-Moreno, Beatriz, Mendoza-Hernández, Ivis, González-Mujica Romero, Raúl, Samón-Tabio, Oscar, Velazco-Villares, Pablo, Bacallao-Castillo, Juan Pablo, Licea-Martín, Ernesto, Rodríguez-Ortega, Misladys, Herrera-Marrero, Nuris, Caballero-González, Esperanza, Egües-Torres, Liudmila, Duartes-González, Reinaldo, García-Blanco, Serguey, Pérez-Cabrera, Suzette, Huete-Ferreira, Santos, Idalmis-Cisnero, Kirenia, Fonte-Galindo, Omayda, Meliá-Pérez, Dania, Rojas-Remedios, Ivonne, Doroud, Delaram, Mehdi Gouya, Mohammad, Biglari, Alireza, Fernández-Castillo, Sonsire, Climent-Ruiz, Yanet, Valdes-Balbín, Yury, García-Rivera, Dagmar, Van der Stuyft, Patrick, and Verez-Bencomo, Vicente
- Abstract
SOBERANA-02 es una vacuna conjugada contra la COVID-19 (RBD recombinante conjugado a toxoide tetánico). Los ensayos clínicos fase 1/2 demostraron la inducción de anticuerpos IgG neutralizantes y respuesta de células T específicas. Una tercera dosis heteróloga de SOBERANA-Plus (dímero RBD) incrementó los anticuerpos neutralizantes. El objetivo de este estudio es evaluar la seguridad y eficacia de dos esquemas de inmunización: dos dosis de SOBERANA-02 y una combinación heteróloga de adicionando una tercera dosis con SOBERANA-Plus.
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- 2022
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13. 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
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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]
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- 2022
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