Browsing by Author "Bueno, Susan M."
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Publication Different Safety Pattern of an Inactivated SARS-CoV-2 Vaccine (CoronaVac®) According to Age Group in a Pediatric Population from 3 to 17 Years Old, in an Open-Label Study in Chile(2023) Le Corre, Nicole; Abarca, Katia; Astudillo, Patricio; Potin, Marcela; López, Sofía; Goldsack, Macarena; Valenzuela, Vania; Schilling Redlich, Andrea; Gaete, Victoria; Rubio, Lilian; Calvo, Mario; Twele, Loreto; González, Marcela; Fuentes, Daniela; Gutiérrez, Valentina; Reyes, Felipe; Tapia, Lorena I.; Villena, Rodolfo; Retamal-Díaz, Angello; Cárdenas, Antonio; Alarcón-Bustamante, Eduardo; Meng, Xing; Xin, Qianqian; González-Aramundiz, José V.; Alvarez-Figueroa, María Javiera; González, Pablo A.; Bueno, Susan M.; Soto, Jorge A.; on behalf of the PedCoronaVac03CL Study Group; Perret, Cecilia; Kalergis, Alexis M.During the COVID-19 pandemic, the importance of vaccinating children against SARS-CoV-2 was rapidly established. This study describes the safety of CoronaVac® in children and adolescents between 3- and 17-years-old in a multicenter study in Chile with two vaccine doses in a 4-week interval. For all participants, immediate adverse events (AEs), serious AEs (SAEs), and AEs of special interest (AESIs) were registered throughout the study. In the safety subgroup, AEs were recorded 28 days after each dose. COVID-19 surveillance was performed throughout the study. A total of 1139 individuals received the first and 1102 the second dose of CoronaVac®; 835 were in the safety subgroup. The first dose showed the highest number of AEs: up to 22.2% of participants reported any local and 17.1% systemic AE. AEs were more frequent in adolescents after the first dose, were transient, and mainly mild. Pain at the inoculation site was the most frequent AE for all ages. Fever was the most frequent systemic AE for 3–5 years old and headache in 6–17 years old. No SAEs or AESIs related to vaccination occurred. Most of the COVID-19 cases were mild and managed as outpatients. CoronaVac® was safe and well tolerated in children and adolescents, with different safety patterns according to age.Item Safety and Immunogenicity of an Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in a Subgroup of Healthy Adults in Chile(2021) 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, Aracely; Oyarzún-Arrau, Aarón; Soto-Rifo, Ricardo; Weiskopf, Daniela; Sette, Alessandro; Zeng, Gang; Meng, Weining; González-Aramundiz, José V.; Kalergis, Alexis M.; CoronaVac03CL Study GroupBackground. The development of effective vaccines against coronavirus disease 2019 is a global priority. CoronaVac is an inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine with promising safety and immunogenicity profiles. This article reports safety and immunogenicity results obtained for healthy Chilean adults aged ≥18 years in a phase 3 clinical trial. 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 volun- teers. 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.