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.

Details

Title
Safety and immunogenicity of SARS-CoV-2 vaccine MVC-COV1901 in Taiwanese adolescents: a randomized phase 2 trial
Author
Liu, Luke Tzu-Chi 1 ; Chiu, Cheng-Hsun 2 ; Chiu, Nan-Chang 3 ; Tan, Boon-Fatt 4   VIAFID ORCID Logo  ; Lin, Chien-Yu 5 ; Cheng, Hao-Yuan 6 ; Lin, Meei-Yun 6 ; Lien, Chia-En 7 ; Chen, Charles 8   VIAFID ORCID Logo  ; Huang, Li-Min 9   VIAFID ORCID Logo 

1  Medigen Vaccine Biologics Corporation, Taipei, Taiwan 
2  Chang Gung University College of Medicine, Department of Pediatrics, Chang Gung Children’s Hospital, Taoyuan City, Taiwan (GRID:grid.145695.a) (ISNI:0000 0004 1798 0922) 
3  MacKay Children’s Hospital, Department of Pediatrics, Taipei City, Taiwan (GRID:grid.145695.a) 
4  National Taiwan University Hospital Hsinchu Branch, Department of Pediatrics, Hsinchu County, Taiwan (GRID:grid.412094.a) (ISNI:0000 0004 0572 7815) 
5  Hsinchu MacKay Memorial Hospital, Department of Pediatrics, Hsinchu City, Taiwan (GRID:grid.413593.9) (ISNI:0000 0004 0573 007X) 
6  Medigen Vaccine Biologics Corporation, Taipei, Taiwan (GRID:grid.413593.9) 
7  Medigen Vaccine Biologics Corporation, Taipei, Taiwan (GRID:grid.413593.9); National Yang-Ming Chiao Tung University, Institute of Public Health, Taipei City, Taiwan (GRID:grid.260539.b) (ISNI:0000 0001 2059 7017) 
8  Medigen Vaccine Biologics Corporation, Taipei, Taiwan (GRID:grid.260539.b) 
9  National Taiwan University, Department of Pediatrics, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan (GRID:grid.19188.39) (ISNI:0000 0004 0546 0241) 
Pages
165
Publication year
2022
Publication date
2022
Publisher
Nature Publishing Group
e-ISSN
20590105
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1038/s41541-022-00589-4
ProQuest document ID
2755010833
Copyright
© The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.