Considerations Papers
The following document reflects the thinking of NIAID/NIH on the scientific, ethical, and logistical issues surrounding the initiation of clinical trials of HIV vaccine candidates in adolescents as of September 2007, before the results of the STEP trial were released. This document does not represent an official NIH policy position.
Considerations for HIV Vaccine Clinical Trials in Adolescents
The purpose of this document is to generate discussion and raise awareness on this significant issue in order to expedite preparation and conduct of HIV vaccine trials in adolescents. Valuable input was provided from individuals within and outside NIAID representing organizations involved in HIV vaccine research and adolescent health issues.
To receive a copy of this document, please contact Thomas Liang at: tliang@niaid.nih.gov.
If you would like to provide feedback, please send your comments to: daidsfeedback@niaid.nih.gov. All comments will be given serious consideration.
Update: this document will be updated soon to reflect the recent results of the STEP/HVTN 502 trial.