Challenges to conducting HIV preventative vaccine trials with adolescents.

摘要: It is estimated that 10.3 million people aged 15-24 are living with HIV infection/AIDS worldwide, 7000 new infections occurring each day. Many of these occur during the adolescent years. These rates infection make adolescents an important target for research in primary prevention. Currently, preparations under way by National Institutes Health-supported networks--the Adolescent Trials Network, Pediatric AIDS Clinical Group, and Vaccines Network--for phase 1/2 vaccine trials involving United States. Identifying challenges to conducting this population a crucial component preparations. Challenges were identified reviewing previous speaking experts HIV/AIDS medicine. Adolescents (typically those younger than 18 years age) minors fall ethical regulatory safeguards their participation clinical including parental permission. may not appropriately perceive personal risk, posing informed consent as well prevention counseling trial. Safety immunogenicity studies likely be required US Food Drug Administration before approval population. Early identification subsequent follow-up high-risk problematic. Vaccine-induced seropositivity present potential barriers military service, employment, marriage, acquiring health insurance. The age at optimal immunization, particularly girls some countries, preadolescence. successful completion must address both States internationally. This report addresses relevant background information, identifies issues surrounding adolescents, discusses what progress has been made, plans implications implementation trials.