Department of Neurology, Chengdu University of Traditional Chinese Medicine Affiliated Hospital, Chengdu, Sichuan, China.
Department of Neurology, Chengdu University of Traditional Chinese Medicine Affiliated Hospital, Chengdu, Sichuan, China
BMJ Open. 2021 Nov 5;11(11):e056106. doi: 10.1136/bmjopen-2021-056106.
COVID-19 has spread with high morbidity and mortality worldwide. Many inactivated SARS-CoV-2 vaccines are being tested at various clinical trial stages for the control and prevention of COVID-19. We aim to comprehensively and objectively evaluate the safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy individuals through a systematic review and meta-analysis of randomised controlled trials (RCTs).
We will search electronic databases of PubMed, the Cochrane Library, Web of Science and EMBASE for RCTs from inception to 31 December 2021. We will also search conference abstracts, reference lists, and grey literature of all available records. Two reviewers will independently screen and extract information from the literature. Bias and the quality of included studies will be evaluated with the risk-bias assessment tool provided by the Cochrane Collaboration. Statistical analysis will be performed using Cochrane's Review Manager (RevMan), V.5.3.
Ethics approval and patient informed consent are not required because we will be including published literature only. The findings of this research will be disseminated in a peer-reviewed journal and likely through other scientific events such as conferences, seminars and symposia.
CRD42021266285.
COVID-19 在全球范围内传播，发病率和死亡率都很高。许多已灭活的 SARS-CoV-2 疫苗正在不同的临床试验阶段进行测试，以控制和预防 COVID-19。我们旨在通过对随机对照试验（RCT）的系统评价和荟萃分析，全面、客观地评估灭活 SARS-CoV-2 疫苗在健康个体中的安全性和免疫原性。
我们将从建库至 2021 年 12 月 31 日，在 PubMed、Cochrane 图书馆、Web of Science 和 EMBASE 电子数据库中检索 RCTs。我们还将检索所有可用记录的会议摘要、参考文献列表和灰色文献。两名评审员将独立筛选和提取文献中的信息。将使用 Cochrane 协作提供的风险偏倚评估工具评估纳入研究的偏倚和质量。统计分析将使用 Cochrane 的 Review Manager（RevMan），V.5.3 进行。
由于我们只包括已发表的文献，因此不需要伦理批准和患者知情同意。本研究的结果将发表在同行评议的期刊上，并可能通过会议、研讨会和专题讨论会等其他科学活动进行发布。
PROSPERO 注册号：CRD42021266285。
