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An inactivated SARS-CoV-2 vaccine is safe and induces humoral and cellular immunity against virus variants in healthy children and adolescents in Chile [article]

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 (+42 others)
2022 medRxiv   pre-print

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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
more » ... 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.
doi:10.1101/2022.02.15.22270973 fatcat:2sygla2p2vd57mkpkc7ybpwkoy
Citation

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, 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, Susan M Bueno, Alexis M Kalergis, PedCoronaVac03CL Study Group. "An inactivated SARS-CoV-2 vaccine is safe and induces humoral and cellular immunity against virus variants in healthy children and adolescents in Chile." medRxiv (2022)