Safety and immunogenicity following a homologous booster dose of CoronaVac in children and adolescents

Lei Wang, Zhiwei Wu, Zhifang Ying, Minjie Li, Yuansheng Hu, Qun Shu, Jing Li, Huixian Wang, Hengming Zhang, Wenbin Jiao, Lin Wang, Yuliang Zhao () and Qiang Gao ()
Additional contact information
Lei Wang: Chinese Center for Disease Control and Prevention
Zhiwei Wu: Hebei Provincial Center for Disease Control and Prevention
Zhifang Ying: National Institutes for Food and Drug Control
Minjie Li: Hebei Provincial Center for Disease Control and Prevention
Yuansheng Hu: Sinovac Biotech Ltd.
Qun Shu: Beijing Key Tech Statistics Technology Co., Ltd.
Jing Li: Sinovac Life Sciences Co., Ltd.
Huixian Wang: Zanhuang County Center for Disease Control and Prevention
Hengming Zhang: Sinovac Biotech Ltd.
Wenbin Jiao: Zanhuang County Center for Disease Control and Prevention
Lin Wang: Sinovac Life Sciences Co., Ltd.
Yuliang Zhao: Hebei Provincial Center for Disease Control and Prevention
Qiang Gao: Sinovac Life Sciences Co., Ltd.

Nature Communications, 2022, vol. 13, issue 1, 1-9

Abstract: Abstract Data on safety and immunity elicited by a third booster dose of inactivated COVID-19 vaccine in children and adolescents are scarce. Here we conducted a study based on a double-blind, randomised, placebo-controlled phase 2 clinical trial (NCT04551547) to assess the safety and immunogenicity of a third dose of CoronaVac. In this study, 384 participants in the vaccine group were assigned to two cohorts. One received the third dose at a 10-months interval (cohort 1) and the other one at a 12-months interval (cohort 2). The primary endpoint is safety and immunogenicity following a third dose of CoronaVac. The secondary endpoint is antibody persistence following the primary two-dose schedule. Severities of local and systemic adverse reactions reported within 28 days after dose 3 were mild and moderate in both cohorts. A third dose of CoronaVac increased GMTs to 681.0 (95%CI: 545.2–850.7) in cohort 1 and 745.2 (95%CI: 577.0–962.3) in cohort 2. Seropositivity rates against the prototype were 100% on day 28 after dose 3. Seropositivity rates against the Omicron variant were 90.6% (cohort 1) and 91.5% (cohort 2). A homologous booster dose of CoronaVac is safe and induces a significant neutralising antibody levels increase in children and adolescents.

Date: 2022
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DOI: 10.1038/s41467-022-34280-y

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