Safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy individuals: protocol for a systematic review and meta-analysis

Introduction 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). Methods and analysis 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 and dissemination 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. PROSPERO registration number CRD42021266285.