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. (January 2023)

• Record Type: Journal Article
• Authors: 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; Vérez-Bencomo, Vicente; 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;
• Is Part Of: International journal of infectious diseases. Volume 126(2023)
• Page Start: 164
• Page End: 173
• Publication Date: 2023-01
• Subjects: COVID-19 -- SARS-CoV-2 -- Conjugate vaccine -- Pediatric vaccine -- Heterologous scheme -- Subunit vaccine -- RBD vaccine; Communicable diseases -- Periodicals; Communicable Diseases -- Periodicals; Communicable diseases; Periodicals; Electronic journals; 616.9
• DOI: 10.1016/j.ijid.2022.11.016
• Languages: English
• ISSNs: 1201-9712

Abstract

Highlights: FINLAY-FR-2 conjugate vaccine is safe and immunogenic in children 3-18 years old. The third dose with FINLAY-FR-1A (dimer receptor binding domain vaccine) increases the immune response. The heterologous three-dose schedule elicited specific T-cell response. This vaccination elicits neutralizing antibodies vs the Delta and Omicron variants of concern. Immune response in children is non-inferior to young adults. 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