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同源加强针接种科兴疫苗对儿童和青少年的安全性和免疫原性。

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

机构信息

National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.

Sinovac Biotech Ltd., Beijing, China.

出版信息

Nat Commun. 2022 Nov 14;13(1):6952. doi: 10.1038/s41467-022-34280-y.

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.

摘要

关于儿童和青少年接种第三剂灭活 COVID-19 疫苗的安全性和免疫原性的数据很少。在这里,我们进行了一项基于双盲、随机、安慰剂对照的 2 期临床试验(NCT04551547)的研究,以评估 CoronaVac 的第三剂安全性和免疫原性。在这项研究中,疫苗组的 384 名参与者被分配到两个队列。一组在 10 个月的间隔(队列 1)接受第三剂,另一组在 12 个月的间隔(队列 2)接受第三剂。主要终点是 CoronaVac 第三剂后的安全性和免疫原性。次要终点是两剂初免后抗体的持久性。两组中,在第 3 剂后 28 天内报告的局部和全身不良反应的严重程度均为轻度和中度。第三剂 CoronaVac 使 GMT 分别增加到队列 1 的 681.0(95%CI:545.2-850.7)和队列 2 的 745.2(95%CI:577.0-962.3)。第 3 剂后 28 天,针对原型的血清阳性率均为 100%。针对奥密克戎变异株的血清阳性率分别为 90.6%(队列 1)和 91.5%(队列 2)。CoronaVac 的同源加强剂量是安全的,并在儿童和青少年中诱导显著的中和抗体水平增加。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/719c/9663494/e4ba59049e20/41467_2022_34280_Fig1_HTML.jpg

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