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 fac-tors 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 in-fluenced 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.