Wallace M, Middelkoop K, Smith P, Pike C, Bennie T, Chandia J, Churchyard G, Gray G, Latka M H, Mathebula M, Nchabeleng M, Roux S, Slack C, Strode A, Bekker L-G
Cancer Association of South Africa, Cape Town, South Africa.
S Afr Med J. 2018 Mar 28;108(4):291-298. doi: 10.7196/SAMJ.2017.v108i4.12909.
HIV/AIDS remains a leading cause of death in adolescents (aged 15 - 25 years), and in sub-Saharan Africa HIV-related deaths continue to rise in this age group despite a decline in both adult and paediatric populations. This is attributable in part to high adolescent infection rates and supports the urgent need for more efficacious prevention strategies. In particular, an even partially effective HIV vaccine, given prior to sexual debut, is predicted to significantly curb adolescent infection rates. While adolescents have indicated willingness to participate in HIV vaccine trials, there are concerns around safety, uptake, adherence, and ethical and logistic issues.
To initiate a national, multisite project with the aim of identifying obstacles to conducting adolescent HIV vaccine trials in South Africa (SA).
A simulated HIV vaccine trial was conducted in adolescents aged 12 - 17 years across five SA research sites, using the already licensed Merck human papillomavirus vaccine Gardasil as a proxy for an HIV vaccine. Adolescents were recruited at community venues and, following a vaccine discussion group, invited to participate in the trial. Consent for trial enrolment was obtained from a parent or legal guardian, and participants aged 16 - 17 years were eligible only if sexually active. Typical vaccine trial procedures were applied during the five study visits, including the administration of vaccination injections at study visits 2, 3 and 4.
The median age of participants was 14 years (interquartile range 13 - 15), with 81% between the ages of 12 and 15 years at enrolment. Overall, 98% of screened participants opted to receive the vaccine, 588 participants enrolled, and 524 (89%) attended the final visit.
This trial showed that adolescents can be recruited, enrolled and retained in clinical prevention trials with parental support. While promising, these results were tempered by the coupling of sexual-risk eligibility criteria and the requirement for parental/guardian consent, which was probably a barrier to the enrolment of high-risk older adolescents. Further debate around appropriate consent approaches for such adolescents in HIV prevention studies is required.
艾滋病毒/艾滋病仍然是青少年（15 - 25岁）死亡的主要原因，在撒哈拉以南非洲，尽管成人和儿童感染艾滋病毒的人数有所下降，但该年龄组与艾滋病毒相关的死亡人数仍在继续上升。这部分归因于青少年的高感染率，这表明迫切需要更有效的预防策略。特别是，一种即使部分有效的艾滋病毒疫苗，在首次性行为之前接种，预计将显著降低青少年感染率。虽然青少年表示愿意参与艾滋病毒疫苗试验，但人们对安全性、接受率、依从性以及伦理和后勤问题仍存在担忧。
启动一个全国性的多地点项目，旨在确定在南非开展青少年艾滋病毒疫苗试验的障碍。
在南非的五个研究地点，对12 - 17岁的青少年进行了一项模拟艾滋病毒疫苗试验，使用已获许可的默克人乳头瘤病毒疫苗加德西作为艾滋病毒疫苗的替代品。在社区场所招募青少年，在疫苗讨论小组之后，邀请他们参与试验。试验入组的同意书由父母或法定监护人签署，16 - 17岁的参与者只有在有性行为时才有资格参加。在五次研究访视期间采用了典型的疫苗试验程序，包括在第2、3和4次访视时进行疫苗注射。
参与者的中位年龄为14岁（四分位间距13 - 15岁），81%的参与者在入组时年龄在12至15岁之间。总体而言，98%的筛查参与者选择接种疫苗，588名参与者入组，524名（89%）参加了最后一次访视。
该试验表明，在父母的支持下，可以招募、入组并留住青少年参与临床预防试验。虽然这些结果很有希望，但性风险资格标准以及父母/监护人同意的要求可能是高风险年龄较大青少年入组的障碍，这使结果受到影响。需要进一步讨论针对此类青少年在艾滋病毒预防研究中合适的同意方式。
