Immunogenicity and safety assessment of a SARS-CoV-2 recombinant spike RBD protein vaccine (Abdala) in paediatric ages 3–18 years old: a double-blinded, multicentre, randomised, phase 1/2 clinical trial (ISMAELILLO study)

Autor: López-Machado, M.A., Rodriguez, D Alonso, Basulto-Puig, J.C., Martin-Hernandez, T., Sánchez-Miranda, D., Agüero-Betancourt, C.M., Besú-García, B., Rodríguez-Fernández, Y., Guerrero-Vega, L., GómezFonseca, I., Ramos-Pérez, O., Acosta-Domínguez, I., Ronquillo-Ramirez, D., Díaz-Fernández, Y., Aguilar-Soto, L., Reíd-Montejo, J., Palomo-Leyva, Y., LandinFaria, M.R., Rosendo-Domínguez, R.M., Alonso-Manresa, C., Marín-Pérez, D.M., Malo-Lantigua, Y., Rodríguez-Florat, M.C., Delgado-Laborit, Y., RodriguezGuevara, Y., Peláez-González, M., Torres-Mora, Y., Cabrera-Hernández, O.S., Gimarais-Varona, F.J., Hormigot-Hernández, M., Artola-Gutiérrez, L.V., Gallardo-Martí, L., Porro-Verdecia, J., Castro-Bistorte, R., RobertsDandie, E., Berenguer-Pedroso, S., Manso-García, Yudith, Mora-García, C.V., Lastre-Muñoz, Y., Duran-Rivero, O., Hernández-García, B., Escobar-Escobar, K., CarmenatesGutiérrez, M.K., Conde-Bello, B., Olazabal-Linares, E.L., Bringas-Labrada, I., Noy-León, M., Velazco-González, N., Bursosa-Moreno, B., Morell-Padrón, Y., Rodríguez-Matos, Y., Treto-Torguet, Y.M., Comas-Díaz, L., Miranda, F., FigueredoGonzález, Y., Quiñones-Juan, A., Mursuli-García, I., Giménez-Velásquez, V.M., Hernández-Ávila, A., Hernández-Cabrera, T., García-Zulueta, T., Parra-Pérez, A., Cintra-Jacob, D., Mendoza-Jiménez, M., de la Fuente-Carbonell, S.M., Hernández-Eduard, B., Ochoa-García, M., Garcia-Iglesias, E., Álvarez-Acosta, A., Martínez-Rosales, R.U., Ávila-Díaz, L., Santana-Vázquez, Z., Mila-Cáceres, L., Guillén-Nieto, G.E., Fuentes-Aguilar, F., Nordelo-Valdivia, A., GonzálezFernández, N., González-Sarmientos, M., Rubio-Salinas, A., Domínguez-Rabilero, L.C., Espinosa-Peña, R.A., Ramírez-Núñez, Y., Junco-Barranco, J., Díaz-González, O., Fragas-Quintero, A., Pérez-Guevara, M.T., Enriquez-Puertas, J.M., Infante-Hernández, Y., Cruz-Sui, O., NoaRomero, E., López, Yizel Hernández, Sánchez-García, J.E., Rodríguez-Martínez, E., Pimentel-Vázquez, E., Martínez-Díaz, E., Cinza-Estévez, Zurina, Resik-Aguirre, Sonia, Figueroa-Baile, Nelvis L., Oquendo-Martínez, Rachel, Campa-Legrá, Ivan, Tejeda-Fuentes, Alina, Rivero-Caballero, Marila, González-García, Gloria, Chávez-Chong, Cristina O., Alonso-Valdés, Marel, Hernández-Bernal, Francisco, Lemos-Pérez, Gilda, Campal-Espinosa, Ana, Freyre-Corrales, Giselle, Benítez-Gordillo, Delia, Gato-Orozco, Evelyn, Pérez Bartutis, Greter Susana, Mesa-Pedroso, Iliana, Bueno-Alemani, Nilda, Infante-Aguilar, Elizabeth, Rodríguez Reinoso, José Luis, Melo-Suarez, Grettel, Limonta-Fernández, Miladys, Ayala-Ávila, Marta, Muzio-González, Verena L.

Publikováno v: In eClinicalMedicine September 2023 63

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.

Autor: Puga-Gómez R; Pediatric Hospital 'Juan Manuel Marquez,' Havana, Cuba; Central Clinic 'Cira García', La Habana, Cuba., Ricardo-Delgado Y; Pediatric Hospital 'Juan Manuel Marquez,' Havana, Cuba., Rojas-Iriarte C; Policlinic '5 de Septiembre', La Habana, Cuba., Céspedes-Henriquez L; Policlinic 'Carlos J. Finlay', La Habana, Cuba., Piedra-Bello M; Pediatric Hospital 'Juan Manuel Marquez,' Havana, Cuba., Vega-Mendoza D; Pediatric Hospital 'Juan Manuel Marquez,' Havana, Cuba., Pérez NP; Pediatric Hospital 'Juan Manuel Marquez,' Havana, Cuba., Paredes-Moreno B; Finlay Vaccine Institute, Havana, Cuba., Rodríguez-González M; Finlay Vaccine Institute, Havana, Cuba., Valenzuela-Silva C; Cybernetics, Mathematics, and Physics Institute, La Habana, Cuba., Sánchez-Ramírez B; Centre of Molecular Immunology, Havana, Cuba., Rodríguez-Noda L; Finlay Vaccine Institute, Havana, Cuba., Pérez-Nicado R; Finlay Vaccine Institute, Havana, Cuba., González-Mugica R; Finlay Vaccine Institute, Havana, Cuba., Hernández-García T; Centre of Molecular Immunology, Havana, Cuba., Fundora-Barrios T; Centre of Molecular Immunology, Havana, Cuba., Echevarría MD; National Civil Defense Research Laboratory, Mayabeque, Cuba., Enriquez-Puertas JM; National Civil Defense Research Laboratory, Mayabeque, Cuba., Infante-Hernández Y; National Civil Defense Research Laboratory, Mayabeque, Cuba., Palenzuela-Díaz A; Centre for Immunoassays, La Habana, Cuba., Gato-Orozco E; Centre for Immunoassays, La Habana, Cuba., Chappi-Estévez Y; National Clinical Trials Coordinating Center, Havana, Cuba., Francisco-Pérez JC; Pediatric Hospital 'Borrás-Marfán', La Habana, Cuba., Suarez-Martinez M; Policlinic 'Carlos J. Finlay', La Habana, Cuba., Castillo-Quintana IC; Finlay Vaccine Institute, Havana, Cuba., Fernandez-Castillo S; Finlay Vaccine Institute, Havana, Cuba., Climent-Ruiz Y; Finlay Vaccine Institute, Havana, Cuba., Santana-Mederos D; Finlay Vaccine Institute, Havana, Cuba., García-Vega Y; Centre of Molecular Immunology, Havana, Cuba., Toledo-Romani ME; 'Pedro Kourí' Tropical Medicine Institute, Habana, Cuba., Doroud D; Pasteur Institute of Iran, Tehran, Islamic Republic of Iran., Biglari A; Pasteur Institute of Iran, Tehran, Islamic Republic of Iran., Valdés-Balbín Y; Finlay Vaccine Institute, Havana, Cuba., García-Rivera D; Finlay Vaccine Institute, Havana, Cuba. Electronic address: dagarcia@finlay.edu.cu., Vérez-Bencomo V; Finlay Vaccine Institute, Havana, Cuba.

Publikováno v: International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases [Int J Infect Dis] 2023 Jan; Vol. 126, pp. 164-173. Date of Electronic Publication: 2022 Nov 18.