National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.
Sinovac Biotech Ltd., Beijing, China.
Nat Commun. 2022 Nov 14;13(1):6952. doi: 10.1038/s41467-022-34280-y.
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.
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。