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Войти в исследования Safety and Immunogenicity of an Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in a Subgroup of Healthy Adults in Chile.
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Bueno Susan M, Abarca Katia, González Pablo A, Gálvez Nicolás M S, Soto Jorge A, Duarte Luisa F, Schultz Bárbara M, Pacheco Gaspar A, González Liliana A, Vázquez Yaneisi, Ríos Mariana, Melo-González Felipe, Rivera-Pérez Daniela, Iturriaga Carolina, Urzúa Marcela, Domínguez Angélica, Andrade Catalina A, Berríos-Rojas Roslye V, Canedo-Marroquín Gisela, Covián Camila, Moreno-Tapia Daniela, Saavedra Farides, Vallejos Omar P, Donato Paulina, Espinoza Pilar, Fuentes Daniela, González Marcela, Guzmán Paula, Muñoz Venturelli Paula, Pérez Carlos M, Potin Marcela, Rojas Álvaro, Fasce Rodrigo A, Fernández Jorge, Mora Judith, Ramírez Eugenio, Gaete-Argel Aracelly, Oyarzún-Arrau Aarón, Valiente-Echeverría Fernando, Soto-Rifo Ricardo, Weiskopf Daniela, Sette Alessandro, Zeng Gang, Meng Weining, González-Aramundiz José V, Kalergis Alexis M
Аннотация
METHODS: Volunteers randomly received 2 doses of CoronaVac or placebo, separated by 2 weeks. A total of 434 volunteers were enrolled, 397 aged 18-59 years and 37 aged ≥60 years. Solicited and unsolicited adverse reactions were registered from all volunteers. Blood samples were obtained from a subset of volunteers and analyzed for humoral and cellular measures of immunogenicity.
RESULTS: The primary adverse reaction in the 434 volunteers was pain at the injection site, with a higher incidence in the vaccine than in the placebo arm. Adverse reactions observed were mostly mild and local. No severe adverse events were reported. The humoral evaluation was performed on 81 volunteers. Seroconversion rates for specific anti-S1-receptor binding domain (RBD) immunoglobulin G (IgG) were 82.22% and 84.44% in the 18-59 year age group and 62.69% and 70.37% in the ≥60 year age group, 2 and 4 weeks after the second dose, respectively. A significant increase in circulating neutralizing antibodies was detected 2 and 4 weeks after the second dose. The cellular evaluation was performed on 47 volunteers. We detected a significant induction of T-cell responses characterized by the secretion of interferon-γ (IFN-γ) upon stimulation with Mega Pools of peptides from SARS-CoV-2.
CONCLUSIONS: Immunization with CoronaVac in a 0-14 schedule in Chilean adults aged ≥18 years is safe, induces anti-S1-RBD IgG with neutralizing capacity, activates T cells, and promotes the secretion of IFN-γ upon stimulation with SARS-CoV-2 antigens.