biostudies-literatureUnknown3(11)Toledo-Romani ME<h4>Background</h4>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.<h4>Method</h4>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 Med (New York, N.Y.)760-773.e5https://www.ebi.ac.uk/biostudies/studies/S-EPMC9359498biostudies-literatureSafety and immunogenicity of anti-SARS-CoV-2 heterologous scheme with SOBERANA 02 and SOBERANA Plus vaccines: Phase IIb clinical trial in adults.PMC9359498Zulueta-Perez LArteaga-Garcia AGarcia-Lopez EDiaz-Hernandez MGarcia-Carmenate MEnriquez-Puertas JDubed-Echevarria MToledo-Romani MEHernandez-Garcia TMartinez-Rivera RBaro-Roman GSantos-Vega BLBiglari AChen GWCruz-Sui OAcosta-Martinez MAReyes-Matienzo RMedinas-Santos GMFontanies-Fernandez MMunoz YRodriguez-Noda LGarcia-Rivera DGalano-Frutos ERodriguez-Gonzalez MGonzalez-Mugica RFernandez-Castillo SSantana-Mederos DGarcia-Vega YGarrido-Arteaga RMendoza-Hernandez ILora-Garcia JCubas-Curbelo MMartinez-Bedoya DPerez-Rodriguez SEspino-Rojas NTMorffi-Cinta IPalenzuela-Diaz ANoa-Romero EPi-Estopinan FOrosa-Vazquez IRivera DGPerez-Guevara MTEspi-Avila JMedina-Napoles MOjito-Magaz ECardoso-SanJorge FRodriguez MAvila-Cabreja JAMorales-Ruano SSanchez-Ramirez BGuillen-Obregon BGomez-Maceo YValenzuela-Silva CBoggiano-Ayo TGarces-Hechavarria AAlfaro-Guzman ARamirez-Gonzalez UValera-Fernandez RMartinez-Perez MValdes-Balbin YBergado-Baez GParedes-Moreno BCliment-Ruiz YSOBERANA Research GroupVerdecia-Sanchez LQuintero-Moreno LSarda-Rodriguez ILDoroud DAcevedo-Martinez YOntivero-Pino IAmoroto MDominguez-Penton YRVerez-Bencomo VGarcia-Montero MRodriguez-Castillo PGPerez-Perez ABrito-Pascual ICoviella-Artime JMEstoque-Cabrera SfalseSafety and immunogenicity of anti-SARS-CoV-2 heterologous scheme with SOBERANA 02 and SOBERANA Plus vaccines: Phase IIb clinical trial in adults.<h4>Background</h4>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.<h4>Method</h4>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 2022-01-01T00:00:00Z2022 Nov2026-05-31T16:07:52.189Z2025-02-19T01:28:20.556ZS-EPMC93594983599862310.1016/j.medj.2022.08.001