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.
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Eugenia-Toledo-Romaní María, Verdecia-Sánchez Leslyhana, Rodríguez-González Meiby, Rodríguez-Noda Laura, Valenzuela-Silva Carmen, Paredes-Moreno Beatriz, Sánchez-Ramírez Belinda, Pérez-Nicado Rocmira, González-Mugica Raul, Hernández-García Tays, Bergado-Baez Gretchen, Pi-Estopiñán Franciscary, Cruz-Sui Otto, Fraga-Quintero Anitza, García-Montero Majela, Palenzuela-Díaz Ariel, Baró-Román Gerardo, Mendoza-Hernández Ivis, Fernandez-Castillo Sonsire, Climent-Ruiz Yanet, Santana-Mederos Darielys, Ramírez Gonzalez Ubel, García-Vega Yanelda, Pérez-Massón Beatriz, Guang-Wu-Chen, Boggiano-Ayo Tammy, Ojito-Magaz Eduardo, Rivera Daniel G, Valdés-Balbín Yury, García-Rivera Dagmar, Vérez-Bencomo Vicente, SOBERANA Research Group, Gómez-Maceo Yanet, Reyes-Matienzo Radamet, Manuel Coviella-Artime José, Morffi-Cinta Irania, Martínez-Pérez Marisel, Castillo-Quintana Ismavy, Garcés-Hechavarría Aniurka, Valera-Fernández Rodrigo, Martínez-Bedoya Dayle, Garrido-Arteaga Raine, Cardoso-SanJorge Félix, Quintero Moreno Lauren, Ontivero-Pino Ivis, Teresa Pérez-Guevara María, Morales-García Marilin, Noa-Romero Enrique, Orosa-Vázquez Ivette, Díaz-Hernández Marianniz, Rojas Gertrudis, Tundidor Yaima, García-López Elena, Muñoz-Morejon Yaima, Galano-Frutos Evelyn, Rodríguez-Alvarez Julián, Arteaga Amaylid, Medina Nápoles Maite, Espi Ávila Jennifer, Fontanies Fernández Marcos
Аннотация
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 secondary outcome was immunogenicity evaluated by anti-RBD IgG ELISA, molecular neutralization of RBD:hACE2 interaction, live-virus-neutralization and specific T-cells response.
RESULTS: The most frequent adverse event (AE) was local pain, other AEs had frequencies ≤ 5%. No serious related-AEs were reported. Phase IIa confirmed the safety in 60 to 80-years-old subjects. In phase-I SOBERANA 02-25 µg elicited higher immune response than SOBERANA 02-15 µg and progressed to phase IIa. Phase IIa results confirmed the immunogenicity of SOBERANA 02-25 µg even in 60-80-years. Two doses of SOBERANA02-25 µg elicited an immune response similar to that of the Cuban Convalescent Serum Panel and it was higher after the homologous and heterologous third doses. The heterologous scheme showed a higher immunological response. Anti-RBD IgG neutralized the delta variant in molecular assay, with a 2.5-fold reduction compared to D614G neutralization.
CONCLUSIONS: SOBERANA 02 was safe and immunogenic in persons aged 19-80 years, eliciting neutralizing antibodies and specific T-cell response. Highest immune responses were obtained in the heterologous three doses protocol.
TRIAL REGISTRY: https://rpcec.sld.cu/trials/RPCEC00000340, https://rpcec.sld.cu/trials/RPCEC00000347.