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
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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
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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
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- 2023
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