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Safety and immunogenicity of anti-SARS-CoV-2 heterologous scheme with SOBERANA 02 and SOBERANA Plus vaccines: Phase IIb clinical trial in adults

2022; Elsevier BV; Volume: 3; Issue: 11 Linguagem: Inglês

10.1016/j.medj.2022.08.001

2666-6359

María Eugenia Toledo-Romaní, Mayra García-Carmenate, Leslyhana Verdecia-Sánchez, Suzel Pérez-Rodríguez, Meybis Rodriguez-González, Carmen Valenzuela‐Silva, Beatriz Paredes-Moreno, Belinda Sánchez-Ramírez, Raúl González-Mugica, Tays Hernández-García, Ivette Orosa-Vázquez, Marianniz Díaz-Hernández, María Teresa Pérez-Guevara, Juliet Enríquez-Puertas, Enrique Noa-Romero, Ariel Palenzuela-Díaz, Gerardo Baró-Román, Ivis Mendoza-Hernández, Yaima Muñoz, Yanet Gómez-Maceo, Bertha Leysi Santos-Vega, Sonsire Fernández-Castillo, Yanet Climent-Ruíz, Laura Rodríguez-Noda, Darielys Santana-Mederos, Yanelda García-Vega, Guang‐Wu Chen, Delaram Doroud, Alireza Biglari, Tammy Boggiano-Ayo, Yury Valdés-Balbín, Daniel G. Rivera, Dagmar García-Rivera, Vicente Vérez-Bencomo, Mailin Cubas-Curbelo, Pedro Gabriel Rodríguez-Castillo, Yosmel Acevedo-Martínez, Solangel Estoque-Cabrera, José Alejandro Ávila-Cabreja, Ainadis Alfaro-Guzmán, Lilian Zulueta-Pérez, Niurka Tamara Espino-Rojas, Gloria Margarita Medinas-Santos, Ileana Luisa Sarda-Rodriguez, Mario Alejandro Acosta-Martinez, Radamet Reyes-Matienzo, José Manuel Coviella-Artime, Irania Morffi-Cinta, Marisel Martínez-Pérez, Rodrigo Valera-Fernández, Aniurka Garcés-Hechavarría, Dayle Martínez-Bedoya, Raine Garrido-Arteaga, Félix Cardoso-SanJorge, Ubel Ramírez-Gonzalez, Lauren Quintero-Moreno, Ivis Ontivero-Pino, Roselyn Martínez-Rivera, Berta Guillén-Obregón, Janet Lora-García, Maite Medina-Nápoles, Jennifer Espi-Ávila, Marcos Fontanies-Fernández, Yeney Regla Domínguez-Pentón, Gretchen Bergado, Franciscary Pi-Estopiñán, Eduardo Ojito-Magaz, Misladys Rodríguez, Otto Cruz-Sui, Majela García-Montero, Marta Dubed-Echevarría, Elena García-López, Evelyn Galano-Frutos, Alina Perez-Perez, Susana Morales-Ruano, Idalmis Brito-Pascual, Maité Amoroto, Amaylid Arteaga-García,

Long-Term Effects of COVID-19

Summary Background 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. Method 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 (IgG) concentration. Secondary outcomes were safety, reactogenicity, and neutralizing antibodies. Findings Seroconversion rate in vaccinees was 76.3% after two doses and 96.8% after the third dose of SOBERANA Plus (7.3% in the placebo group). Neutralizing IgG antibodies were detected against D614G and variants of concern (VOCs) Alpha, Beta, Delta, and Omicron. Specific, functional antibodies were detected 7–8 months after the third dose. The frequency of serious adverse events (AEs) associated with vaccination was very low (0.1%). Local pain was the most frequent AE. Conclusions Two doses of SOBERANA 02 were safe and immunogenic in adults. The heterologous combination with SOBERANA Plus increased neutralizing antibodies, detectable 7–8 months after the third dose. Trial registry https://rpcec.sld.cu/trials/RPCEC00000347 Funding This work was supported by Finlay Vaccine Institute, BioCubaFarma, and the Fondo Nacional de Ciencia y Técnica (FONCI-CITMA-Cuba, contract 2020-20).