Volk Jonathan E, Hessol Nancy A, Gray Glenda E, Kublin James G, Churchyard Gavin J, Mlisana Koleka, Nchabeleng Maphoshane, Buchbinder Susan P, Bekker Linda-Gail
Bridge HIV, Department of Public Health, San Francisco, CA, USA.
Int J STD AIDS. 2014 Apr;25(5):332-40. doi: 10.1177/0956462413506892. Epub 2013 Oct 8.
By comparing younger to older participants enrolled in a HIV vaccine efficacy trial, we aimed to gain insights into the inclusion of adolescents in future trials. This was a sub-analysis of a multisite HIV vaccine randomized clinical trial in South Africa, conducted January-September 2007. Motivations for trial enrolment, social harms, adverse events and loss to follow-up were compared between younger (18-20 years old) and older participants (21-35 years old). Both younger (n = 238) and older participants (n = 563) were equally likely to report enrolling for altruistic reasons. Younger females were less likely than older participants to join for trial reimbursement (p = 0.005), while younger males were more likely to enrol because the vaccine may provide protection from HIV-acquisition (p < 0.001). There were no significant differences in the number of social harms reported. Compared to males over 20 years old, 18-20-year-old females were less likely to experience adverse events (OR = 0.1, CI 0.01-0.80) and no more likely to be lost to follow-up (OR = 0.7, CI 0.39-1.25), while 18-20-year-old males were no more likely to experience adverse events (OR = 1.3, CI 0.58-2.83) or loss to follow-up (OR = 0.8, CI 0.51-1.41). Our data support the inclusion of younger participants who are at risk for HIV in future HIV vaccine efficacy trials.
通过比较参与一项HIV疫苗疗效试验的年轻参与者和年长参与者，我们旨在深入了解未来试验中纳入青少年的情况。这是对2007年1月至9月在南非进行的一项多中心HIV疫苗随机临床试验的亚分析。比较了年轻（18 - 20岁）和年长参与者（21 - 35岁）参与试验的动机、社会危害、不良事件和失访情况。年轻参与者（n = 238）和年长参与者（n = 563）同样有可能报告出于利他原因参与试验。年轻女性因试验报销而参与的可能性低于年长参与者（p = 0.005），而年轻男性因疫苗可能提供预防HIV感染的保护而参与的可能性更高（p < 0.001）。报告的社会危害数量没有显著差异。与20岁以上男性相比，18 - 20岁女性发生不良事件的可能性较小（OR = 0.1，CI 0.01 - 0.80），失访可能性也不更高（OR = 0.7，CI 0.39 - 1.25），而18 - 20岁男性发生不良事件（OR = 1.3，CI 0.58 - 2.83）或失访（OR = 0.8，CI 0.51 - 1.41）的可能性也不更高。我们的数据支持在未来的HIV疫苗疗效试验中纳入有HIV感染风险的年轻参与者。
