Chimoyi Lucy, Kamndaya Mphatso, Venables Emilie, von Knorring Nina, Stadler Jonathan, MacPhail Catherine, Chersich Matthew F, Rees Helen, Delany-Moretlwe Sinead
Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Division of Social and Behavioural Sciences, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
BMC Public Health. 2017 Jul 4;17(Suppl 3):524. doi: 10.1186/s12889-017-4355-z.
Developing an effective HIV vaccine is the overriding priority for HIV prevention research. Enrolling and maintaining cohorts of men into HIV vaccine efficacy trials is a necessary prerequisite for the development and licensure of a safe and efficacious vaccine.
One hundred-fifty consenting HIV-negative men were enrolled into a pilot 1:1 randomised controlled trial of immediate vaccination with a three-dose hepatitis B vaccine compared to deferred vaccination (at 12 months) to investigate feasibility and acceptability of a future HIV vaccine trial in this population. Adverse events, changes in risk behaviour, acceptability of trial procedures and motivations for participation in future trials were assessed.
Men were a median 25 years old (inter-quartile range = 23-29), 53% were employed, 90% secondary school educated and 67% uncircumcised. Of the 900 scheduled study visits, 90% were completed in the immediate vaccination arm (405/450) and 88% (396/450) in the delayed arm (P = 0.338). Acceptability of trial procedures and services was very high overall. However, only 65% of the deferred group strongly liked being randomised compared to 90% in the immediate group (P = 0.001). Informed consent processes were viewed favourably by 92% of the delayed and 82% of the immediate group (P = 0.080). Good quality health services, especially if provided by a male nurse, were rated highly. Even though almost all participants had some concern about the safety of a future HIV vaccine (98%), the majority were willing to participate in a future trial. Future trial participation would be motivated mainly by the potential for accessing an effective vaccine (81%) and altruism (75%), rather than by reimbursement incentives (2%).
Recruitment and retention of men into vaccine trials is feasible and acceptable in our setting. Findings from this surrogate vaccine trial show a high willingness to participate in future HIV vaccine trials. While access to potentially effective vaccines is important, quality health services are an equally compelling incentive for enrolment.
研发一种有效的HIV疫苗是HIV预防研究的首要任务。招募并维持男性队列参与HIV疫苗效力试验是研发和批准安全有效的疫苗的必要前提。
150名同意参与试验的HIV阴性男性被纳入一项1:1的试点随机对照试验，将立即接种三剂乙肝疫苗与延迟接种（12个月后）进行比较，以调查该人群未来HIV疫苗试验的可行性和可接受性。评估不良事件、风险行为的变化、试验程序的可接受性以及参与未来试验的动机。
男性的年龄中位数为25岁（四分位间距=23-29岁），53%有工作，90%接受过中学教育，67%未行包皮环切术。在900次计划的研究访视中，立即接种组完成了90%（405/450），延迟接种组完成了88%（396/450）（P=0.338）。试验程序和服务的总体可接受性非常高。然而，延迟组中只有65%的人非常喜欢被随机分组，而立即接种组为90%（P=0.001）。延迟组92%、立即接种组82%对知情同意过程评价良好（P=0.080）。优质的医疗服务，尤其是由男护士提供的服务，得到了高度评价。尽管几乎所有参与者都对未来HIV疫苗的安全性有所担忧（98%），但大多数人愿意参与未来的试验。未来参与试验的主要动机将是有可能获得有效疫苗（81%）和利他主义（75%），而不是报销激励（2%）。
在我们的研究环境中，招募和留住男性参与疫苗试验是可行且可接受的。这项替代疫苗试验的结果表明，人们非常愿意参与未来的HIV疫苗试验。虽然获得潜在有效的疫苗很重要，但优质的医疗服务同样是促使人们参与试验的有力因素。
