biostudies-literatureUnknown126Puga-Gomez R<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 immunologicInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases164-173https://www.ebi.ac.uk/biostudies/studies/S-EPMC9673084biostudies-literatureOpen-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.PMC9673084Alvarez-Montalvo DFundora-Barrios TInfante-Hernandez YDiaz-Hernandez MGarcia-Lopez AToledo-Romani MEHernandez-Garcia TBaro-Roman GBiglari ALopez-Gonzalez LCazanas-Quintana YReyes-Gonzalez YCruz-Sui ORodriguez-Noda LBarrios TFGarcia-Rivera DFernandez DRHRodriguez-Gonzalez MGonzalez-Mugica RFernandez-Castillo SPerez-Nicado REnriquez-Puertas JMSantana-Mederos DGarcia-Vega YPerez NPMartinez-Bedoya DGalindo OFPalenzuela-Diaz ASuarez-Martinez MRicardo-Delgado YPiedra-Bello MDel Valle Rodriguez RNoa-Romero EMuro SROquendo-de la Cruz YPi-Estopinan FOrosa-Vazquez IEchevarria MDMedina-Napoles MGarcia-Cristia YSanchez-Ramirez BGonzalez-Alvarez ABValenzuela-Silva CGarces-Hechavarria AGorrita-Mora LValera-Fernandez RMartinez-Perez MCaballero-Gonzalez EValdes-Balbin YBergado-Baez GParedes-Moreno BCliment-Ruiz YSOBERANA Research GroupVerdecia-Sanchez LGrillo-Fortun RDoroud DOntivero-Pino IDominguez-Penton YRVerez-Bencomo VChappi-Estevez YCespedes-Henriquez LGato-Orozco EFrancisco-Perez JCPuga-Gomez RRojas-Iriarte CCastillo-Quintana ICMesa-Herrera MEVega-Mendoza DfalseOpen-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.<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 immunologic2023-01-01T00:00:00Z2023 Jan2025-04-22T18:01:02.071Z2025-04-22T18:01:02.071ZS-EPMC96730843640381910.1016/j.ijid.2022.11.016