Adolescents and trial participation
South African researcher Ann Strode (University of Kwa Zulu Natal) highlighted the complexities of enrolling adolescents into AIDS vaccine trials. Young women aged 15-24 are particularly vulnerable to HIV infection—in South Africa, for example, 25% of women are HIV-infected by the time they are 22 years old. To prevent HIV infection in this age group it will be important to vaccinate adolescents or, possibly, pre-pubescent girls who have not yet become sexually active. Most licensed vaccines for other diseases have been tested in children (after preliminary safety tests in adults), since children are the primary recipient of these protective vaccinations. But AIDS vaccines will be tested in adults before they are evaluated in adolescents or children. If a vaccine shows efficacy in adults it will be necessary to show that the vaccine has the same immune and safety profile in adolescents and that the effects last for several years.
There are many challenges involved in enrolling young people in trials of AIDS prevention strategies. One overarching issue is that many countries have varied or conflicting regulations regarding young people’s participation in trials. South Africa is one example of a country where “children have limited but evolving legal capacity,” Strode reported. For example, young people can obtain contraceptives at the age of 14 without parental consent, they can have sex at 16, and young women are allowed to terminate a pregnancy at any age. However, Strode noted, South Africa has “no independent age for [children to] consent to research.”
Strode recommended that countries develop national systems to recruit adolescents for AIDS prevention trials and that research and human rights groups work together on advocacy for legal and ethical reform of age of consent laws. She also recommended further research on children’s ability to understand the risks and benefits of trial participation.
~ For more information: “Adolescents: The Missing Cohort” in AIDS Vaccine Advocacy Coalition Annual Report 2004 at www.avac.org