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Inclusion of Adolescents in Preventive HIV Vaccine Trials: Public Health Policy and Research Design at a Crossroads

Jaspan, Heather B MD, PhD*; Cunningham, Coleen K MD; Tucker, Tim J P MBChB, PhD; Wright, Peter F MD§; Self, Steve G PhD∥¶; Sheets, Rebecca L PhD#; Rogers, Audrey S PhD, MPH**; Bekker, Linda-Gail MBChB, PhD*; Wilson, Craig M MD††; Duerr, Ann MD, MPH; Wasserheit, Judith N MD, MPH∥¶the HIV Vaccine Adolescent Trials Working Group

JAIDS Journal of Acquired Immune Deficiency Syndromes: January 1st, 2008 - Volume 47 - Issue 1 - p 86-92
doi: 10.1097/QAI.0b013e31815d2f27
Epidemiology and Social Science

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.

From the *Desmond Tutu HIV Centre, University of Cape Town, South Africa; †Duke University Medical Center, Durham, NC; ‡University of Cape Town, Cape Town, South Africa; §Vanderbilt University Medical Center, Nashville, TN; ∥Fred Hutchinson Cancer Research Center, Seattle, WA; ¶University of Washington, Seattle, WA; #National Institute of Allergy and Infectious Diseases, Bethesda, MD; **National Institute of Child Health and Human Development, Bethesda, MD; and the ††University of Alabama at Birmingham, Birmingham.

Received for publication March 27, 2007; accepted October 4, 2007.

The opinions expressed by the authors do not necessarily represent the opinions or policies of the agencies with which they are affiliated. No conflicts of interest exist.

Correspondence to: Heather Jaspan, MD, PhD, University of Cape Town, Faculty of Health Sciences, Anzio Road, Observatory, Cape Town, South Africa 7705 (e-mail: heather.jaspan@hiv-research.org.za).

© 2008 Lippincott Williams & Wilkins, Inc.