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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

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机构： [1]‘‘Pedro Kourı´’’ Tropical Medicine Institute, Av ‘‘Novia del Mediodı´a’’, Kv 6 1/2, La Lisa, Havana 11400, Cuba [2]"19 de Abril" Polyclinic, Tulipan St. between Panorama y Oeste, Nuevo Vedado, Plaza de la Revolucio´ n, Havana 10400, Cuba [3]Clinic #1, 21 St. and 190, La Lisa, Havana, Cuba [4]Finlay Vaccine Institute, 21st Avenue Nº 19810 Between 198 and 200 St, Atabey, Playa, Havana, Cuba [5]Cybernetics, Mathematics and Physics Institute, 15th St. #55, Vedado, Plaza de la Revolucio´ n, Havana 10400, Cuba [6]Center of Molecular Immunology, 15th Avenue and 216 St, Siboney, Playa, Havana, Cuba [7]National Civil Defense Research Laboratory, San Jose´ de las Lajas, Mayabeque, Cuba [8]Centre for Immunoassays, 134 St. and 25, Cubanaca´ n, Playa, Havana 11600 Cuba [9]National Clinical Trials Coordinating Center, 5th Avenue and 62, Miramar, Playa, Havana, Cuba [10]Chengdu Olisynn Biotech. Co. Ltd., Chengdu 610041, People’s Republic of China [11]State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, People’s Republic of China [12]Pasteur Institute of Iran, No. 69, Pasteur Avenue, Tehran 1316943551, Islamic Republic of Iran [13]Laboratory of Synthetic and Biomolecular Chemistry, Faculty of Chemistry, University of Havana, Havana 10400, Cuba

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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.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.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.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.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).Copyright © 2022 Elsevier Inc. All rights reserved.

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第一作者机构： [1]‘‘Pedro Kourı´’’ Tropical Medicine Institute, Av ‘‘Novia del Mediodı´a’’, Kv 6 1/2, La Lisa, Havana 11400, Cuba

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