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首页> 外文期刊>Vaccine >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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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

机译：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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Background: 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. 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 mu g RBD-conjugated to 20 mu g of TT) in 40 subjects, 19-59-years-old. Phase Ila was open-label including 100 volunteers 19-80-years, receiving two doses of SOBERANA 02-25 mu g. 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 Ila confirmed the safety in 60 to 80-years-old subjects. In phase-I SOBERANA 02-25 mu g elicited higher immune response than SOBERANA 02-15 mu g and progressed to phase IIa. Phase IIa results confirmed the immunogenicity of SOBERANA 02-25 mu g even in 6080-years. Two doses of SOBERANA02-25 mu g 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. (C) 2022 Elsevier Ltd. All rights reserved.

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