Feasibility and acceptability of conducting HIV vaccine trials in adolescents in South Africa: Going beyond willingness to participate towards implementation
Background. 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.
Objectives. To initiate a national, multisite project with the aim of identifying obstacles to conducting adolescent HIV vaccine trials in South Africa (SA).
Method. 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.
Results. 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.
Conclusions. 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.
M Wallace, Cancer Association of South Africa, Cape Town, South Africa
K Middelkoop, Desmond Tutu HIV Centre, Faculty of Health Sciences, University of Cape Town, South Africa
P Smith, Desmond Tutu HIV Centre, Faculty of Health Sciences, University of Cape Town, South Africa
C Pike, Desmond Tutu HIV Centre, Faculty of Health Sciences, University of Cape Town, South Africa
T Bennie, International Partnership for Microbicides, Paarl, South Africa
J Chandia, HIV Vaccine Research Unit, Faculty of Health Sciences, Walter Sisulu University, Mthatha, South Africa
G Churchyard, The Aurum Institute, Johannesburg, South Africa
G Gray, Perinatal HIV Research Unit, Chris Hani Baragwanath Academic Hospital and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; South African Medical Research Council, Johannesburg, South Africa
M H Latka, The Aurum Institute, Johannesburg, South Africa
M Mathebula, MeCRU Clinical Research Unit, Department of Microbiological Pathology, School of Healthcare Sciences, Sefako Makgatho Health Sciences University, Pretoria, South Africa
M Nchabeleng, MeCRU Clinical Research Unit, Department of Microbiological Pathology, School of Healthcare Sciences, Sefako Makgatho Health Sciences University, Pretoria, South Africa
S Roux, Synexus Clinical Research SA (Pty) Ltd, Somerset West, South Africa
C Slack, Vaccines Ethics Group, Discipline of Psychology, College of Humanities, University of KwaZulu-Natal, Pietermaritzburg, South Africa
A Strode, Centre for Socio-Legal Studies, School of Law, University of KwaZulu-Natal, Pietermaritzburg, South Africa
L-G Bekker, Desmond Tutu HIV Centre, Faculty of Health Sciences, University of Cape Town, South Africa
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Date published: 2018-03-28
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