2021•medRxivOpen access
Safety and immunogenicity of anti-SARS CoV-2 vaccine SOBERANA 02 in homologous or heterologous scheme
María Eugenia Toledo-Romaní, Leslihana Verdecia-Sánchez, Meybis Rodriguez-González, Laura Rodríguez-Noda, Carmen Valenzuela‐Silva, Beatriz Paredes-Moreno, Belinda Sanchez-Ramirez, Rocmira Pérez-Nicado, Raúl González-Mugica, Tays Hernández-García, Gretchen Bergado, Franciscary Pi-Estopiñán, Otto Cruz-Sui, Anitza Fraga-Quintero, Majela García-Montero, Ariel Palenzuela-Díaz, Gerardo Baro-Roman, Ivis Mendosa-Hernández, Sonsire Fernández-Castillo, Yanet Climent-Ruíz, Darielys Santana-Mederos, Ubel Ramírez Gonzalez, Yanelda García-Vega, Beatriz Pérez-Massón, Guang-Wu-Chen, Tammy Boggiano-Ayo, Eduardo Ojito, Daniel G. Rivera, Yury Valdés-Balbín, Dagmar García-Rivera, Vicente Vérez-Bencomo
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Abstract
Abstract Background SOBERANA 02 is a COVID-19 conjugate vaccine candidate based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid. SOBERANA Plus antigen is dimeric-RBD. Here we report safety, reactogenicity and immunogenicity from phase I and IIa clinical trials using two-doses SOBERANA 02 (homologous protocol) and three-doses (homologous) or heterologous (with SOBERANA Plus) protocols. Method We performed an open-label, monocentric, sequential and adaptive phase I for evaluating safety, reactogenicity and exploring immunogenicity of SOBERANA 02 in two formulations (15 and 25 μg) 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 received a third dose of SOBERANA 02, half received a heterologous dose of SOBERANA Plus-50 μg. Primary outcomes were safety and reactogenicity. The secondary outcome was vaccine immunogenicity evaluated by anti-RBD IgG ELISA, molecular neutralization test of RBD:hACE2 interaction, live-virus neutralization test and specific T-cells response. Results The most frequent AE was local pain, other AEs had frequencies ≤ 5%. No serious related AEs were reported. Phase IIa confirmed the safety results in 60–80 years subjects. In phase-I SOBERANA 02-25µg elicited higher immune response than SOBERANA 02-15 µg; in consequence, the higher dose progressed to phase IIa. Phase IIa results confirmed the immunogenicity of SOBERANA 02-25 μg even in 60–80 age range. Two doses of SOBERANA02-25 μg elicited an immune response similar to that of the Cuban Convalescent Serum Panel; it was higher after both the homologous and heterologous third doses; the heterologous scheme showing a higher immunological response. 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 and https://rpcec.sld.cu/trials/RPCEC00000347
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