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Adolescents and HIV Vaccine Trials

What Are the Clinical Trial Site Issues?

The Desmond Tutu HIV Centre, The Institute of Infectious Disease and Molecular Medicine, University of Cape Town Faculty of Health Sciences, Werhner and Beit Building, North Anzio Road, Mowbray, Cape Town 7925, South Africa; linda-gail.bekker{at}hiv-research.org.za

Heather Jaspan, MD, PhD, FAAP

Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa

James McIntyre, MBChB, MRCOG

Perinatal HIV Research Unit, University of Witwatersrand, Chris Hani Baragwaneth Hospital, Johannesburg, South Africa

Robin Wood, BSc, BM, DTMLM, MMED, FCP(SA)

Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa

Glenda Gray, MBBCh, FCPaed(SA)

Perinatal HIV Research Unit, University of Witwatersrand, Chris Hani Baragwaneth Hospital, Johannesburg, South Africa

Adolescents worldwide are at high risk for HIV, which makes them essential candidates for HIV vaccine trials. However, enrollment of adolescents into such trials has implications for trial sites. Adolescents are considered vulnerable subjects and require proxy consent in addition to their assent, which brings issues of confidentiality and access into play. HIV vaccine trial sites often do not have experience recruiting and retaining adolescents, and creating youth-friendly environments that are comfortable for guardians. This includes development of education materials that target both youth and their parents. Because these trials are of minimal individual benefit, sites will likely need to provide service in the form of health care and supportive structures to adolescents. Finally, a number of trial design options exist, and researchers will need to balance the risks and benefits of each, as for all issues surrounding the involvement of adolescents in HIV vaccine trials.

Key Words: adolescents • HIV vaccine clinical trials • operational issues • trial design

Journal of the International Association of Physicians in AIDS Care (JIAPAC), Vol. 4, No. 4, 93-97 (2005)
DOI: 10.1177/1545109705284836


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