作者
María Eugenia-Toledo-Romaní, Leslyhana Verdecia-Sánchez, Meiby Rodríguez-González, Laura Rodríguez-Noda, Carmen Valenzuela-Silva, Beatriz Paredes-Moreno, Belinda Sánchez-Ramírez, Rocmira Pérez-Nicado, Raul González-Mugica, Tays Hernández-García, Gretchen Bergado-Baez, Franciscary Pi-Estopiñán, Otto Cruz-Sui, Anitza Fraga-Quintero, Majela García-Montero, Ariel Palenzuela-Díaz, Gerardo Baró-Román, Ivis Mendoza-Hernández, Sonsire Fernandez-Castillo, Yanet Climent-Ruiz, Darielys Santana-Mederos, Ubel Ramírez Gonzalez, Yanelda García-Vega, Beatriz Pérez-Massón, Tammy Boggiano-Ayo, Eduardo Ojito-Magaz, Daniel G Rivera, Yury Valdés-Balbín, Dagmar García-Rivera, Vicente Vérez-Bencomo, Yanet Gómez-Maceo, Radamet Reyes-Matienzo, José Manuel Coviella-Artime, Irania Morffi-Cinta, Marisel Martínez-Pérez, Ismavy Castillo-Quintana, Aniurka Garcés-Hechavarría, Rodrigo Valera-Fernández, Dayle Martínez-Bedoya, Raine Garrido-Arteaga, Félix Cardoso-SanJorge, Lauren Quintero Moreno, Ivis Ontivero-Pino, María Teresa Pérez-Guevara, Marilin Morales-García, Enrique Noa-Romero, Ivette Orosa-Vázquez, Marianniz Díaz-Hernández, Gertrudis Rojas, Yaima Tundidor, Elena García-López, Yaima Muñoz-Morejon, Evelyn Galano-Frutos, Julián Rodríguez-Alvarez, Amaylid Arteaga, Maite Medina Nápoles, Jennifer Espi Ávila, Marcos Fontanies Fernández, SOBERANA Research Group
发表日期
2022/7/29
期刊
Vaccine
卷号
40
期号
31
页码范围
4220-4230
出版商
Elsevier
简介
Background
SOBERANA 02 is a COVID-19 vaccine based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid (TT). SOBERANA Plus antigen is dimeric-RBD. Here we report safety and immunogenicity from phase I and IIa clinical trials using two-doses of SOBERANA 02 and three-doses (homologous) or heterologous (with SOBERANA Plus) protocols.
Method
We performed an open-label, sequential and adaptive phase I to evaluate safety and explore the immunogenicity of SOBERANA 02 in two formulations (15 or 25 μg RBD-conjugated to 20 μg of TT) in 40 subjects, 19–59-years-old. Phase IIa was open-label including 100 volunteers 19–80-years, receiving two doses of SOBERANA 02–25 μg. In both trials, half of volunteers were selected to receive a third dose of the corresponding SOBERANA 02 and half received a heterologous dose of SOBERANA Plus. Primary outcome was safety. The …
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M Eugenia-Toledo-Romaní, L Verdecia-Sánchez… - Vaccine, 2022