作者
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, Constanza Mendez, Benjamín Diethelm-Varela, Patricio 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 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, Pablo A González, Katia Abarca, Cecilia Perret, Leandro J Carreño, Alexis M Kalergis, Susan M Bueno
发表日期
2022/2/22
期刊
medRxiv
页码范围
2022.02. 15.22270973
出版商
Cold Spring Harbor Laboratory Press
简介
Background
Multiple vaccines against SARS-CoV-2 have been evaluated in clinical trials, but very few include the pediatric population. The inactivated vaccine CoronaVac® has shown to be safe and immunogenic in a phase 1/2 clinical trial in a pediatric cohort in China. This study is an interim safety and immunogenicity report of a phase 3 clinical trial for CoronaVac® in healthy children and adolescents in Chile.
Methods
Participants aged 3 to 17 years old received two doses of CoronaVac® in a four-week interval. Local and systemic adverse reactions were registered in 699 participants that received the first dose and 381 that received the second dose until December 31st, 2021. Whole blood samples were collected from 148 participants for humoral and cellular immunity analyses.
Results
The primary adverse reaction reported after the first and second dose was pain at the injection site. The adverse reactions observed were primarily mild and local, and no severe adverse events were reported. Four weeks after the second dose, a significant increase in the levels of total and neutralizing antibodies was observed. Increased activation of specific CD4+ T cells was also observed four weeks after the second dose. Although antibodies induced by vaccination neutralize variants Delta and Omicron, titers were lower than the D614G variant. Importantly, comparable T cell responses were detected against these variants of concern.
Conclusions
CoronaVac® is safe and immunogenic in subjects aged 3-17 years old and is thus likely to confer protection against infection caused by SARS-CoV-2 variants in this target population.
学术搜索中的文章
JA Soto, F Melo-González, C Gutierrez-Vera… - medRxiv, 2022