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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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机构： [1]"Pedro Kourí" Tropical Medicine Institute, Av "Novia del Mediodía", Kv 6 1/2, La Lisa, Habana 11400, Cuba. [2]Clinic #1. 21 St. and 190, La Lisa, Habana, Cuba. [3]Finlay Vaccine Institute, 21st Ave. N° 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba. [4]Cybernetics, Mathematics and Physics Institute, 15(th) Street #55, Vedado, Plaza de la Revolución, La Habana 10400, Cuba. [5]Centre of Molecular Immunology, 15(th) Ave. and 216 Street, Siboney, Playa, Havana, Cuba. [6]National Civil Defense Research Laboratory. San José de las Lajas, Mayabeque, Cuba. [7]Centre for Immunoassays, 134 St and 25, Cubanacán, Playa, La Habana 11600, Cuba. [8]National Clinical Trials Coordinating Center, 5th Ave and 62, Miramar, Playa, Havana, Cuba. [9]Chengdu Olisynn Biotech. Co. Ltd., and State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, People's Republic of China. [10]Laboratory of Synthetic and Biomolecular Chemistry, Faculty of Chemistry, University of Havana, Havana 10400, Cuba.

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关键词： COVID-19 SARS-CoV-2 Conjugate vaccine Heterologous immunization scheme Subunit vaccine

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SOBERANA 02 is a COVID-19 vaccine based on SARS-CoV-2 recombinant RBD conjugated to tetanus toxoid (TT). SOBERANA Plus antigen is dimeric-RBD. Here we report safety and immunogenicity from phase I and IIa clinical trials using two-doses of SOBERANA 02 and three-doses (homologous) or heterologous (with SOBERANA Plus) protocols.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.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.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.https://rpcec.sld.cu/trials/RPCEC00000340, https://rpcec.sld.cu/trials/RPCEC00000347.Copyright © 2022 Elsevier Ltd. All rights reserved.

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出版当年[2022]版：

大类 | 3 区医学

小类 | 3 区医学：研究与实验 3 区免疫学

最新[2023]版：

大类 | 3 区医学

小类 | 3 区免疫学 3 区医学：研究与实验

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第一作者机构： [1]"Pedro Kourí" Tropical Medicine Institute, Av "Novia del Mediodía", Kv 6 1/2, La Lisa, Habana 11400, Cuba.

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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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