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奥密克戎 BA.5 感染的灭活 COVID-19 疫苗加强针效力:成人密切接触者的匹配队列研究。

Effectiveness of the booster dose of inactivated COVID-19 vaccine against Omicron BA.5 infection: a matched cohort study of adult close contacts.

机构信息

School of Public Health, Xinjiang Medical University, Urumqi, 830017, China.

Urumqi Center for Disease Control and Prevention, Urumqi, 830026, China.

出版信息

Respir Res. 2023 Oct 12;24(1):246. doi: 10.1186/s12931-023-02542-y.

Abstract

BACKGROUND

Although COVID-19 vaccines and their booster regimens protect against symptomatic infections and severe outcomes, there is limited evidence about their protection against asymptomatic and symptomatic infections in real-world settings, particularly when considering that the majority of SARS-CoV-2 Omicron infections were asymptomatic. We aimed to assess the effectiveness of the booster dose of inactivated vaccines in mainland China, i.e., Sinopharm (BBIBP-CorV) and Sinovac (CoronaVac), against Omicron infection in an Omicron BA.5 seeded epidemic.

METHODS

Based on an infection-naive but highly vaccinated population in Urumqi, China, the study cohort comprised all 37,628 adults who had a contact history with individuals having SARS-CoV-2 infections, i.e., close contacts, between August 1 and September 7, 2022. To actively detect SARS-CoV-2 infections, RT-PCR tests were performed by local authorities on a daily basis for all close contacts, and a testing-positive status was considered a laboratory-confirmed outcome. The cohort of close contacts was matched at a ratio of 1:5 with the fully vaccinated (i.e., 2 doses) and booster vaccinated groups (i.e., 3 doses) according to sex, age strata, calendar date, and contact settings. Multivariate conditional logistic regression models were adopted to estimate the marginal effectiveness of the booster dose against Omicron BA.5 infection after adjusting for confounding variables. Subgroup analyses were performed to assess vaccine effectiveness (VE) in different strata of sex, age, the time lag from the last vaccine dose to exposure, and the vaccination status of the source case. Kaplan-Meier curves were employed to visualize the follow-up process and testing outcomes among different subgroups of the matched cohort.

FINDINGS

Before matching, 37,099 adult close contacts were eligible for cohort enrolment. After matching, the 2-dose and 3-dose groups included 3317 and 16,051 contacts, and the proportions with Omicron infections were 1.03% and 0.62% among contacts in the 2-dose and 3-dose groups, respectively. We estimated that the adjusted effectiveness of the inactivated booster vaccine versus 2 doses against Omicron infection was 35.5% (95% CI 2.0, 57.5). The booster dose provided a higher level of protection, with an effectiveness of 60.2% (95% CI 22.8, 79.5) for 15-180 days after vaccination, but this VE decreased to 35.0% (95% CI 2.8, 56.5) after 180 days. Evidence for the protection of the booster dose was detected among young adults aged 18-39 years, but was not detected for those aged 40 years or older.

INTERPRETATION

The receipt of the inactivated vaccine booster dose was associated with a significantly lower Omicron infection risk, and our findings confirmed the vaccine effectiveness (VE) of booster doses against Omicron BA.5 variants. Given the rapid evolution of SARS-CoV-2, we highlight the importance of continuously monitoring the protective performance of vaccines against the genetic variants of SARS-CoV-2, regardless of existing vaccine coverage.

摘要

背景

尽管 COVID-19 疫苗及其加强剂方案可预防有症状感染和严重后果,但在现实环境中,关于其对无症状和有症状感染的保护作用的证据有限,特别是在考虑到大多数 SARS-CoV-2 奥密克戎感染为无症状感染的情况下。我们旨在评估灭活疫苗在中国内地(即国药(BBIBP-CorV)和科兴(CoronaVac))加强剂量对奥密克戎 BA.5 播种流行中的奥密克戎感染的有效性。

方法

基于中国乌鲁木齐一个感染率低但疫苗接种率高的人群,研究队列包括所有 2022 年 8 月 1 日至 9 月 7 日期间与 SARS-CoV-2 感染者有接触史的 37628 名成年人,即密切接触者。为了主动检测 SARS-CoV-2 感染,当地卫生部门每天对所有密切接触者进行 RT-PCR 检测,检测阳性结果被视为实验室确诊结果。根据性别、年龄层、日历日期和接触环境,将密切接触者队列按 1:5 的比例与完全接种(即 2 剂)和加强接种(即 3 剂)组进行匹配。采用多变量条件逻辑回归模型,在调整混杂因素后,估计加强剂量对奥密克戎 BA.5 感染的边际有效性。进行亚组分析,以评估不同性别、年龄、从最后一剂疫苗到暴露的时间间隔和源病例疫苗接种状态的疫苗有效性(VE)。Kaplan-Meier 曲线用于可视化匹配队列中不同亚组的随访过程和检测结果。

结果

在匹配前,有 37099 名成年密切接触者符合入组条件。匹配后,2 剂和 3 剂组分别包括 3317 名和 16051 名接触者,2 剂和 3 剂组的接触者中奥密克戎感染的比例分别为 1.03%和 0.62%。我们估计,与 2 剂相比,灭活加强疫苗对奥密克戎感染的调整有效性为 35.5%(95%CI 2.0,57.5)。加强剂量提供了更高水平的保护,接种后 15-180 天的有效性为 60.2%(95%CI 22.8,79.5),但 180 天后的 VE 降至 35.0%(95%CI 2.8,56.5)。在 18-39 岁的年轻成年人中发现了加强剂量的保护作用,但在 40 岁及以上的成年人中未发现。

结论

接种灭活疫苗加强剂量与奥密克戎感染风险显著降低相关,我们的研究结果证实了加强剂量对奥密克戎 BA.5 变异株的疫苗有效性(VE)。鉴于 SARS-CoV-2 的快速演变,我们强调无论现有疫苗接种率如何,持续监测 SARS-CoV-2 遗传变异株疫苗的保护性能非常重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6a7a/10571409/2688603681e1/12931_2023_2542_Fig1_HTML.jpg

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