Inclusion of adolescents in preventive HIV vaccine trials: public health policy and research design at a crossroads.

TitleInclusion of adolescents in preventive HIV vaccine trials: public health policy and research design at a crossroads.
Publication TypePublication
Year of Publication2008
AuthorsJaspan HB, Cunningham CK, Tucker TJP, Wright PF, Self SG, Sheets RL, Rogers AS, Bekker L-G, Wilson CM, Duerr A, Wasserheit JN
Corporate AuthorsHIV Vaccine Adolescent Trials Working Group
JournalJ Acquir Immune Defic Syndr
Volume47
Issue1
Pagination86-92
Date Published2008 Jan 01
ISSN1525-4135
KeywordsAdolescent, AIDS Vaccines, Female, Health Policy, Humans, Male, Research Design
Abstract

The search for a safe effective HIV vaccine has been a centerpiece of HIV research for almost 2 decades. More than 60 clinical HIV vaccine trials have been conducted to date. Several promising candidate HIV vaccines are in advanced clinical development. To date, however, no trial has included adolescents, one of the most important target groups for any preventive HIV vaccine. To license a vaccine for use in this age group, efficacy data or, at a minimum, bridging safety and immunogenicity data in this population are needed. To accomplish this, several critical issues and special challenges in the development and implementation of HIV vaccine trials in adolescents must be addressed, including regulatory considerations, potential differentials in safety and immunogenicity, alternative trial design strategies, recruitment and retention challenges, community involvement models, and approaches to informed consent/assent. This article examines these issues and proposes specific next steps to facilitate the routine inclusion of this high-priority population in preventive HIV vaccine trials as early and seamlessly as possible.

DOI10.1097/QAI.0b013e31815d2f27
Alternate JournalJ. Acquir. Immune Defic. Syndr.
PubMed ID17984759
Grant ListU01 HD040474 / HD / NICHD NIH HHS / United States
U01 HD040533 / HD / NICHD NIH HHS / United States
UM1 AI069519 / AI / NIAID NIH HHS / United States