| Abstract |
A safe and effective HIV vaccine is our
best hope of stopping the AIDS pandemic. As women under the
age of 25 are at increased risk of acquiring HIV infection,
this vaccine will need to be delivered to adolescents and
young adult women once it is available. Scientific challenges
include the fact that an effective HIV vaccine may not have
fully measurable correlates of immunity such as antibody production
or cytotoxic T cell response. One implication of this challenge
is that adolescents will need to be enrolled in initial Phase
III HIV vaccine efficacy studies. Bridging studies that demonstrate
vaccine induced immunity among adolescents may not be possible.
Adolescents have not yet been enrolled in HIV vaccine trials,
and barriers to their enrollment are anticipated. Vaccine
trials for another sexually transmitted infection, Human papillomavirus
(HPV) are ongoing, and others are planned. Although adolescents
have participated in these trials and may accept a licensed
HPV vaccine, this may not be indicative of attitudes toward
an HIV vaccine. Unlike HPV, the stigma of HIV vaccine trial
participation and vaccine-induced HIV infection may be two
of the multiple barriers to HIV vaccine trial participation
among young, at-risk women. In the proposed study we will
examine attitudes toward HIV as compared to HPV vaccines in
terms of both trial participation and receipt of a licensed
vaccine. Participants will include 100 high-risk young women
aged 18-21, and 100 high-risk adolescent women aged 15-21.
100 parents or guardians of the adolescents will also participate.
In addition to attitudes, HIV risk factos and potential facilitators
of HIV vaccine trial participation will explored. The Principal
Investigator fo the project is Dr. Michelle Lally. Dr. Lally
has experience with multiple HIV vaccine trials, serving as
the PI for the Brown HIV Vaccine Trials Unit of the NIH-sponsored
HIV vaccine Trials Network, as well as HIV vaccine trials
sponsored directly by VaxGen and Merck. She also has research
experience in infectious disease epidemiology among substance
using adult women. This will be Dr. Lally’s first study
of an adolescent population. Dr. Pugatch, and infectious disease
specialist and pediatrician with considerable adolescent research
experience, will assist Dr. Lally on this study. Dr. Kenneth
Mayer, the head of the Lifespan/Tufts/Brown CFAR Prevention
Core, will serve as the senior research advisor on this project.
The investigators all have AIDS-related research support.
It is anticipated that the data from this Pilot project will
be used to develop an intervention to assure HIV vaccine trial
participation of high-risk adolescent and young adult women.
Dr. Lally will use the data from this Pilot project to apply,
with the Co-Investigators, for an NIH funded R01.
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