Journal des essais cliniques
Libre accès

Abstrait

A Randomized Placebo-controlled Trial to Evaluate the Efficacy, Immunogenicity and Safety of an Inactivated COVID-19 Vaccine (CoronaVac®) in Children and Adolescents

Nicolás MS Gálvez, Qiangian Xin, Katia Abarca, María J Álvarez-Figueroa, Sanet Aspinall, Susan M Bueno, José V González-Aramundiz, Nicole Le Corre, Weining Meng, Xing Meng, Cecilia Perret, Jorge A Soto, Gang Zen3, Alexis M Kalergis*

Background: The inactivated COVID-19 vaccine developed by Sinovac (CoronaVac^®) has been shown to effectively prevent Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections. Phase I/II clinical trials in healthy adults aged 18-59 and over 60 showed good safety and immunogenicity in China. Phase III clinical trials are currently being carried out in Brazil, Indonesia, Chile, and Turkey. The WHO approved CoronaVac^® for emergency use in adults on June 01, 2021. A Phase I/II clinical trial in children and teenagers aged 3-17 was performed in China in 2020.

Methods: This is a global multi-center, randomized, double-blinded, and placebo-controlled phase III clinical trial that aims to assess the safety, efficacy, and immunogenicity of CoronaVac^® in the pediatric population. This vaccine will be administered to infants, children, and adolescents aged 6 months to 17 years and compared to a placebo. Five countries will participate in this study, South Africa, Malaysia, Kenya, the Philippines and Chile. This report will focus on the study to be performed in Chile. Volunteers will randomly receive two intramuscular doses of CoronaVac^® or the control comparator (placebo), in a 1:1 ratio, with an interval of 28 days between each dose. The study will be finished after the last visit of the last volunteer. Efficacy assessments include the surveillance of COVID-19-like symptoms, clinical laboratory confirmation of SARS-CoV-2 infection by RT-PCR, and recording of COVID-19-related hospitalizations. Safety assessment considers monitoring Adverse Events (AEs) within 30 minutes after administration of each dose and monitoring and collecting of Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) until 12 months after the first dose. Immunogenicity assessments will focus on neutralizing and anti-Spike protein antibodies and will be performed in a sub-group of volunteers. Any confirmed COVID-19 case will be followed until resolution. Total RNA of saliva samples will be obtained from confirmed COVID-19 cases for viral genome sequencing to detect SARS-CoV-2 circulating variants of concern.

Discussion: Vaccination of children and teenagers will be a crucial step in controlling the spread of COVID-19 and will also be fundamental to prevent the emergence of syndromes such as Long-COVID and PIMS-TS.