{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["126"],"submitter":["Puga-Gomez R"],"pubmed_abstract":["<h4>Objectives</h4>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.<h4>Methods</h4>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 immunologic"],"journal":["International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases"],"pagination":["164-173"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9673084"],"repository":["biostudies-literature"],"pubmed_title":["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."],"pmcid":["PMC9673084"],"pubmed_authors":["Alvarez-Montalvo D","Fundora-Barrios T","Infante-Hernandez Y","Diaz-Hernandez M","Garcia-Lopez A","Toledo-Romani ME","Hernandez-Garcia T","Baro-Roman G","Biglari A","Lopez-Gonzalez L","Cazanas-Quintana Y","Reyes-Gonzalez Y","Cruz-Sui O","Rodriguez-Noda L","Barrios TF","Garcia-Rivera D","Fernandez DRH","Rodriguez-Gonzalez M","Gonzalez-Mugica R","Fernandez-Castillo S","Perez-Nicado R","Enriquez-Puertas JM","Santana-Mederos D","Garcia-Vega Y","Perez NP","Martinez-Bedoya D","Galindo OF","Palenzuela-Diaz A","Suarez-Martinez M","Ricardo-Delgado Y","Piedra-Bello M","Del Valle Rodriguez R","Noa-Romero E","Muro SR","Oquendo-de la Cruz Y","Pi-Estopinan F","Orosa-Vazquez I","Echevarria MD","Medina-Napoles M","Garcia-Cristia Y","Sanchez-Ramirez B","Gonzalez-Alvarez AB","Valenzuela-Silva C","Garces-Hechavarria A","Gorrita-Mora L","Valera-Fernandez R","Martinez-Perez M","Caballero-Gonzalez E","Valdes-Balbin Y","Bergado-Baez G","Paredes-Moreno B","Climent-Ruiz Y","SOBERANA Research Group","Verdecia-Sanchez L","Grillo-Fortun R","Doroud D","Ontivero-Pino I","Dominguez-Penton YR","Verez-Bencomo V","Chappi-Estevez Y","Cespedes-Henriquez L","Gato-Orozco E","Francisco-Perez JC","Puga-Gomez R","Rojas-Iriarte C","Castillo-Quintana IC","Mesa-Herrera ME","Vega-Mendoza D"],"additional_accession":[]},"is_claimable":false,"name":"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.","description":"<h4>Objectives</h4>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.<h4>Methods</h4>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 immunologic","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 Jan","modification":"2025-04-22T18:01:02.071Z","creation":"2025-04-22T18:01:02.071Z"},"accession":"S-EPMC9673084","cross_references":{"pubmed":["36403819"],"doi":["10.1016/j.ijid.2022.11.016"]}}