{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["3(11)"],"submitter":["Toledo-Romani ME"],"pubmed_abstract":["Background
SOBERANA 02 has been evaluated in phase I and IIa studies comparing homologous versus heterologous schedule (this one, including SOBERANA Plus). Here, we report results of immunogenicity, safety, and reactogenicity of SOBERANA 02 in a two- or three-dose heterologous scheme in adults.Method
Phase IIb was a parallel, multicenter, adaptive, double-blind, randomized, and placebo-controlled trial. Subjects (n = 810) aged 19-80 years were randomized to receive two doses of SARS-CoV-2 RBD conjugated to tetanus toxoid (SOBERANA 02) and a third dose of dimeric RBD (SOBERANA Plus) 28 days apart; two production batches of active ingredients of SOBERANA 02 were evaluated. Primary outcome was the percentage of seroconverted subjects with ≥4-fold the anti-RBD immunoglobulin G "],"journal":["Med (New York, N.Y.)"],"pagination":["760-773.e5"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9359498"],"repository":["biostudies-literature"],"pubmed_title":["Safety and immunogenicity of anti-SARS-CoV-2 heterologous scheme with SOBERANA 02 and SOBERANA Plus vaccines: Phase IIb clinical trial in adults."],"pmcid":["PMC9359498"],"pubmed_authors":["Zulueta-Perez L","Arteaga-Garcia A","Garcia-Lopez E","Diaz-Hernandez M","Garcia-Carmenate M","Enriquez-Puertas J","Dubed-Echevarria M","Toledo-Romani ME","Hernandez-Garcia T","Martinez-Rivera R","Baro-Roman G","Santos-Vega BL","Biglari A","Chen GW","Cruz-Sui O","Acosta-Martinez MA","Reyes-Matienzo R","Medinas-Santos GM","Fontanies-Fernandez M","Munoz Y","Rodriguez-Noda L","Garcia-Rivera D","Galano-Frutos E","Rodriguez-Gonzalez M","Gonzalez-Mugica R","Fernandez-Castillo S","Santana-Mederos D","Garcia-Vega Y","Garrido-Arteaga R","Mendoza-Hernandez I","Lora-Garcia J","Cubas-Curbelo M","Martinez-Bedoya D","Perez-Rodriguez S","Espino-Rojas NT","Morffi-Cinta I","Palenzuela-Diaz A","Noa-Romero E","Pi-Estopinan F","Orosa-Vazquez I","Rivera DG","Perez-Guevara MT","Espi-Avila J","Medina-Napoles M","Ojito-Magaz E","Cardoso-SanJorge F","Rodriguez M","Avila-Cabreja JA","Morales-Ruano S","Sanchez-Ramirez B","Guillen-Obregon B","Gomez-Maceo Y","Valenzuela-Silva C","Boggiano-Ayo T","Garces-Hechavarria A","Alfaro-Guzman A","Ramirez-Gonzalez U","Valera-Fernandez R","Martinez-Perez M","Valdes-Balbin Y","Bergado-Baez G","Paredes-Moreno B","Climent-Ruiz Y","SOBERANA Research Group","Verdecia-Sanchez L","Quintero-Moreno L","Sarda-Rodriguez IL","Doroud D","Acevedo-Martinez Y","Ontivero-Pino I","Amoroto M","Dominguez-Penton YR","Verez-Bencomo V","Garcia-Montero M","Rodriguez-Castillo PG","Perez-Perez A","Brito-Pascual I","Coviella-Artime JM","Estoque-Cabrera S"],"additional_accession":[]},"is_claimable":false,"name":"Safety and immunogenicity of anti-SARS-CoV-2 heterologous scheme with SOBERANA 02 and SOBERANA Plus vaccines: Phase IIb clinical trial in adults.","description":"Background
SOBERANA 02 has been evaluated in phase I and IIa studies comparing homologous versus heterologous schedule (this one, including SOBERANA Plus). Here, we report results of immunogenicity, safety, and reactogenicity of SOBERANA 02 in a two- or three-dose heterologous scheme in adults.Method
Phase IIb was a parallel, multicenter, adaptive, double-blind, randomized, and placebo-controlled trial. Subjects (n = 810) aged 19-80 years were randomized to receive two doses of SARS-CoV-2 RBD conjugated to tetanus toxoid (SOBERANA 02) and a third dose of dimeric RBD (SOBERANA Plus) 28 days apart; two production batches of active ingredients of SOBERANA 02 were evaluated. Primary outcome was the percentage of seroconverted subjects with ≥4-fold the anti-RBD immunoglobulin G ","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Nov","modification":"2026-05-31T16:07:52.189Z","creation":"2025-02-19T01:28:20.556Z"},"accession":"S-EPMC9359498","cross_references":{"pubmed":["35998623"],"doi":["10.1016/j.medj.2022.08.001"]}}