Safety and immunogenicity of SARS-CoV-2 vaccine MVC-COV1901 in Taiwanese adolescents: a randomized phase 2 trial
Journal
NPJ vaccines
Journal Volume
7
Journal Issue
1
Date Issued
2022-12-16
Author(s)
Liu, Luke Tzu-Chi
Chiu, Cheng-Hsun
Chiu, Nan-Chang
Tan, Boon-Fatt
Lin, Chien-Yu
Cheng, Hao-Yuan
Lin, Meei-Yun
Lien, Chia-En
Chen, Charles
Abstract
Adolescents and children play an important role in SARS-CoV-2 transmission and epidemiology. MVC-COV1901 is a subunit SARS-CoV-2 vaccine based on stabilized spike protein adjuvanted with CpG 1018 and aluminum hydroxide that has received emergency use approval (EUA) for adults in Taiwan. In this study, we have investigated the safety and immunogenicity of two doses of MVC-COV1901 in adolescents. Healthy adolescents from the age of 12-17 years were randomly assigned to receive two intramuscular doses of either MVC-COV1901 or placebo at 28 days apart. Adverse events were mostly mild and were similar in MVC-COV1901 and placebo groups, with the most commonly reported adverse events being pain/tenderness and malaise/fatigue. All immunogenicity endpoints in the adolescent group were non-inferior to the endpoints seen in the young adult and placebo groups. The results here advocate the use of MVC-COV1901 in adolescents in the ongoing efforts to control the pandemic.ClinicalTrials.gov registration: NCT04951388.
Publisher
NATURE PORTFOLIO
Type
journal article