Acceptance and Factors Associated With Participation in Functional Cure–Related Trials Among People Living With HIV: A Cross-sectional Study in Southern China

HIV remains a global health challenge,and research efforts directed towards a functional cure require people living with HIV(PLHIV)in-volvement in clinical trials.Our study assessed willingness to participate in HIV functional cure–related clinical trials and associated factors among PLHIV in Guangzhou,China,using a questionnaire survey approach.We analyzed responses from 718 questionnaires,finding that 71.2%were willing to participate in Phase Ⅲtrials,while 51.7%were willing to participate in Phase I trials and 42.9%expressed acceptability for analytic treatment interruption.Multivariate logistic regression demonstrated that male PLHIV,those with awareness of functional cure,and PLHIV,who had been on antiretroviral therapy(ART)for less than 1 year,were more willing to partic-ipate in Phase Ⅲtrials.Those with a body mass index greater than 24,and those without resistance to ART drug were more willing to participate in Phase I trials.The major motivations for participation in Phase Ⅲtrials were access to cutting-edge treatments(62.6%)and supporting research(55.3%).Safety was the main concern contributing to hesitancy.Our study revealed a high willingness to participate in HIV functional cure–related trials among PLHIV in Guangzhou,China,and willingness varied across different trial phases and was influenced by multiple factors.This study provides valuable references for future clinical trial recruitment strategies and public health policy formulation.

Safety of SARS-CoV-2 vaccines:a systematic review and meta-analysis of randomized controlled trials

Background Various modalities of vaccines against coronavirus disease 2019(COVID-19),based on different platforms and immunization procedures,have been successively approved for marketing worldwide.A comprehensive review for clinical trials assessing the safety of COVID-19 vaccines is urgently needed to make an accurate judgment for mass vaccination.Main text A systematic review and meta-analysis was conducted to determine the safety of COVID-19 vaccine candidates in randomized controlled trials(RCTs).Data search was performed in PubMed,Embase,Cochrane library,Scopus,Web of Science,and MedRxiv.Included articles were limited to RCTs on COVID-19 vaccines.A total of 73,633 subjects from 14 articles were included to compare the risks of adverse events following immunization(AEFI)after vaccinating different COVID-19 vaccines.Pooled risk ratios(RR)of total AEFI for inactivated vaccine,viral-vectored vaccine,and mRNA vaccine were 1.34[95%confidence interval(CI)1.11–1.61,P<0.001],1.65(95%CI 1.31–2.07,P<0.001),and 2.01(95%CI 1.78–2.26,P<0.001),respectively.No significant differences on local and systemic AEFI were found between the first dose and second dose.In addition,people aged≤55 years were at significantly higher risk of AEFI than people aged≥56 years,with a pooled RR of 1.25(95%CI 1.15–1.35,P<0.001).Conclusions The safety and tolerance of current COVID-19 vaccine candidates are acceptable for mass vaccination,with inactivated COVID-19 vaccines candidates having the lowest reported AEFI.Long-term surveillance of vaccine safety is required,especially among elderly people with underlying medical conditions.