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A randomized, double-blind phase I clinical trial of two recombinant dimeric RBD COVID-19 vaccine candidates: Safety, reactogenicity and immunogenicity.
Pérez-Rodríguez S, de la Caridad Rodríguez-González M, Ochoa-Azze R, Climent-Ruiz Y, Alberto González-Delgado C, Paredes-Moreno B, Valenzuela-Silva C, Rodríguez-Noda L, Perez-Nicado R, González-Mugica R, Martínez-Pérez M, Sánchez-Ramírez B, Hernández-García T, Díaz-Machado A, Tamayo-Rodríguez M, Martín-Trujillo A, Rubino-Moreno J, Suárez-Batista A, Dubed-Echevarría M, Teresa Pérez-Guevara M, Amoroto-Roig M, Chappi-Estévez Y, Bergado-Báez G, Pi-Estopiñán F, Chen GW, Valdés-Balbín Y, García-Rivera D, Verez-Bencomo V. Pérez-Rodríguez S, et al. Among authors: pi estopinan f. Vaccine. 2022 Mar 18;40(13):2068-2075. doi: 10.1016/j.vaccine.2022.02.029. Epub 2022 Feb 8. Vaccine. 2022. PMID: 35164986 Free PMC article. Clinical Trial.
Safety and immunogenicity of anti-SARS CoV-2 vaccine SOBERANA 02 in homologous or heterologous scheme: Open label phase I and phase IIa clinical trials.
Eugenia-Toledo-Romaní M, Verdecia-Sánchez L, Rodríguez-González M, Rodríguez-Noda L, Valenzuela-Silva C, Paredes-Moreno B, Sánchez-Ramírez B, Pérez-Nicado R, González-Mugica R, Hernández-García T, Bergado-Baez G, Pi-Estopiñán F, Cruz-Sui O, Fraga-Quintero A, García-Montero M, Palenzuela-Díaz A, Baró-Román G, Mendoza-Hernández I, Fernandez-Castillo S, Climent-Ruiz Y, Santana-Mederos D, Ramírez Gonzalez U, García-Vega Y, Pérez-Massón B, Guang-Wu-Chen, Boggiano-Ayo T, Ojito-Magaz E, Rivera DG, Valdés-Balbín Y, García-Rivera D, Vérez-Bencomo V; SOBERANA Research Group; Gómez-Maceo Y, Reyes-Matienzo R, Manuel Coviella-Artime J, Morffi-Cinta I, Martínez-Pérez M, Castillo-Quintana I, Garcés-Hechavarría A, Valera-Fernández R, Martínez-Bedoya D, Garrido-Arteaga R, Cardoso-SanJorge F, Quintero Moreno L, Ontivero-Pino I, Teresa Pérez-Guevara M, Morales-García M, Noa-Romero E, Orosa-Vázquez I, Díaz-Hernández M, Rojas G, Tundidor Y, García-López E, Muñoz-Morejon Y, Galano-Frutos E, Rodríguez-Alvarez J, Arteaga A, Medina Nápoles M, Espi Ávila J, Fontanies Fernández M. Eugenia-Toledo-Romaní M, et al. Among authors: pi estopinan f. Vaccine. 2022 Jul 29;40(31):4220-4230. doi: 10.1016/j.vaccine.2022.05.082. Epub 2022 Jun 6. Vaccine. 2022. PMID: 35691871 Free PMC article. Clinical Trial.
A cell-based ELISA as surrogate of virus neutralization assay for RBD SARS-CoV-2 specific antibodies.
Pi-Estopiñan F, Pérez MT, Fraga A, Bergado G, Díaz GD, Orosa I, Díaz M, Solozábal JA, Rodríguez LM, Garcia-Rivera D, Macías C, Jerez Y, Casadesús AV, Fernández-Marrero B, Bermúdez E, Plasencia CA, Sánchez B, Hernández T. Pi-Estopiñan F, et al. Vaccine. 2022 Mar 18;40(13):1958-1967. doi: 10.1016/j.vaccine.2022.02.044. Epub 2022 Feb 15. Vaccine. 2022. PMID: 35193792 Free PMC article.
Safety and immunogenicity of anti-SARS-CoV-2 heterologous scheme with SOBERANA 02 and SOBERANA Plus vaccines: Phase IIb clinical trial in adults.
Toledo-Romani ME, García-Carmenate M, Verdecia-Sánchez L, Pérez-Rodríguez S, Rodriguez-González M, Valenzuela-Silva C, Paredes-Moreno B, Sanchez-Ramirez B, González-Mugica R, Hernández-Garcia T, Orosa-Vázquez I, Díaz-Hernández M, Pérez-Guevara MT, Enriquez-Puertas J, Noa-Romero E, Palenzuela-Diaz A, Baro-Roman G, Mendoza-Hernández I, Muñoz Y, Gómez-Maceo Y, Santos-Vega BL, Fernandez-Castillo S, Climent-Ruiz Y, Rodríguez-Noda L, Santana-Mederos D, García-Vega Y, Chen GW, Doroud D, Biglari A, Boggiano-Ayo T, Valdés-Balbín Y, Rivera DG, García-Rivera D, Vérez-Bencomo V; SOBERANA Research Group. Toledo-Romani ME, et al. Med. 2022 Nov 11;3(11):760-773.e5. doi: 10.1016/j.medj.2022.08.001. Epub 2022 Aug 8. Med. 2022. PMID: 35998623 Free PMC article. Clinical Trial.
Development of a scalable single process for producing SARS-CoV-2 RBD monomer and dimer vaccine antigens.
Boggiano-Ayo T, Palacios-Oliva J, Lozada-Chang S, Relova-Hernandez E, Gomez-Perez J, Oliva G, Hernandez L, Bueno-Soler A, Montes de Oca D, Mora O, Machado-Santisteban R, Perez-Martinez D, Perez-Masson B, Cabrera Infante Y, Calzadilla-Rosado L, Ramirez Y, Aymed-Garcia J, Ruiz-Ramirez I, Romero Y, Gomez T, Espinosa LA, Gonzalez LJ, Cabrales A, Guirola O, de la Luz KR, Pi-Estopiñan F, Sanchez-Ramirez B, Garcia-Rivera D, Valdes-Balbin Y, Rojas G, Leon-Monzon K, Ojito-Magaz E, Hardy E. Boggiano-Ayo T, et al. Among authors: pi estopinan f. Front Bioeng Biotechnol. 2023 Nov 17;11:1287551. doi: 10.3389/fbioe.2023.1287551. eCollection 2023. Front Bioeng Biotechnol. 2023. PMID: 38050488 Free PMC article.
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.
Puga-Gómez R, Ricardo-Delgado Y, Rojas-Iriarte C, Céspedes-Henriquez L, Piedra-Bello M, Vega-Mendoza D, Pérez NP, Paredes-Moreno B, Rodríguez-González M, Valenzuela-Silva C, Sánchez-Ramírez B, Rodríguez-Noda L, Pérez-Nicado R, González-Mugica R, Hernández-García T, Fundora-Barrios T, Echevarría MD, Enriquez-Puertas JM, Infante-Hernández Y, Palenzuela-Díaz A, Gato-Orozco E, Chappi-Estévez Y, Francisco-Pérez JC, Suarez-Martinez M, Castillo-Quintana IC, Fernandez-Castillo S, Climent-Ruiz Y, Santana-Mederos D, García-Vega Y, Toledo-Romani ME, Doroud D, Biglari A, Valdés-Balbín Y, García-Rivera D, Vérez-Bencomo V; SOBERANA Research Group. Puga-Gómez R, et al. Int J Infect Dis. 2023 Jan;126:164-173. doi: 10.1016/j.ijid.2022.11.016. Epub 2022 Nov 18. Int J Infect Dis. 2023. PMID: 36403819 Free PMC article. Clinical Trial.