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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
COVID-19, SARS-CoV-2, Conjugate vaccine, Pediatric vaccine, Heterologous scheme, Subunit vaccine, Infectious and parasitic diseases, RC109-216
Abstract

Objectives: To evaluate a heterologous vaccination scheme in children 3-18 years old (y/o) combining two SARS-CoV-2r- receptor binding domain (RBD)protein vaccines. Methods: A 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. Results: Local 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. Conclusion: The heterologous scheme was safe and immunogenic in children 3-18 y/o. Trial registry: https://rpcec.sld.cu/trials/RPCEC00000374

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

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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