Examinando por Autor "Marcela Potin"

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    Ítem
    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) Nicole Le Corre; Katia Abarca; Patricio Astudillo; Marcela Potin; Sofía López; Macarena Goldsack; Vania Valenzuela; Andrea Schilling; Victoria Gaete; Lilian Rubio; Mario Calvo; Loreto Twele; Marcela González; Daniela Fuentes; Valentina Gutiérrez; Felipe Reyes; Lorena I. Tapia; Rodolfo Villena; Angello Retamal-Díaz; Antonio Cárdenas; Eduardo Alarcón-Bustamante; Xing Meng; Qianqian Xin; José V. González-Aramundiz; María Javiera Álvarez-Figueroa; Pablo A. González; Susan M. Bueno; Jorge A. Soto; Cecilia Perret; Alexis M. Kalergis
    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.
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    Ítem
    Inactivated Vaccine-Induced SARS-CoV-2 Variant-SpecificImmunity in Children
    (2022) Jorge A. Soto; Felipe Melo González; Cristián Gutierrez Vera; Bárbara M. Schultz; Roslye V. Berríos Rojas; Daniela Rivera Pérez; Alejandro Piña Iturbe; Guillermo Hoppe Elsholz; Luisa F. Duarte; Yaneisi Vázquez; Daniela Moreno Tapia; Mariana Ríos; Pablo A. Palacios; Richard Garcia Betancourt; Álvaro Santibañez; Gaspar A. Pacheco; Constanza Mendez; Catalina A. Andrade; Pedro H. Silva; Benjamín Diethelm Varela; Patricia Astudillo; Mario Calvo; Antonio Cárdenas; Marcela González; Macarena Goldsack; Valentina Gutiérrez; Marcela Potin; Andrea Schilling; Lorena I. Tapia; Loreto Twele; Rodolfo Villena; Alba Grifoni; Alessandro Sette; Daniela Weiskopf; Rodrigo A. Fasce; Jorge Fernández; Judith Mora; Eugenio Ramírez; Aracelly Gaete Argel; Mónica L. Acevedo; Fernando Valiente Echeverría; Ricardo Soto Rifo; Angello Retamal Díaz; Nathalia Muñoz Jofré; PedCoronaVac03CL Study Group; Xing Meng; Qianqian Xin; Eduardo Alarcón Bustamante; José V. González Aramundiz; Nicole Le Corre; María Javiera Álvarez Figueroa; Pablo A. González; Katia Abarca; Cecilia Perret; Leandro J. Carreño; Susan M. Bueno; Alexis M. Kalergis
    Multiple vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been evaluated in clinical trials. However, trials addressing the immune response in the pediatric population are scarce. The inactivated vaccine CoronaVac has been shown to be safe and immunogenic in a phase 1/2 clinical trial in a pediatric cohort in China. Here, we report interim safety and immunogenicity results of a phase 3 clinical trial for CoronaVac in healthy children and adolescents in Chile. Participants 3 to 17 years old received two doses of CoronaVac in a 4-week interval until 31 December 2021. Local and systemic adverse reactions were registered for volunteers who received one or two doses of CoronaVac. Whole-blood samples were collected from a subgroup of 148 participants for humoral and cellular immunity analyses. The main adverse reaction reported after the first and second doses was pain at the injection site. Four weeks after the second dose, an increase in neutralizing antibody titer was observed in subjects relative to their baseline visit. Similar results were found for activation of specific CD41 T cells. Neutralizing antibodies were identified against the Delta and Omicron variants. However, these titers were lower than those for the D614G strain. Importantly, comparable CD41 T cell responses were detected against these variants of concern. Therefore, CoronaVac is safe and immunogenic in subjects 3 to 17 years old, inducing neutralizing antibody secretion and activating CD41 T cells against SARS-CoV-2 and its variants. (This study has been registered at ClinicalTrials .gov under no. NCT04992260.)