Women make up the fastest growing group of new AIDS cases in the United States, and are increasingly at risk of HIV through sexual transmission. In the absence of a safe and tested microbicide, a preventive vaccine for HIV is believed to offer the greatest hope to halt the epidemic. In 1999, the first HIV vaccine efficacy trial ever was launched by VaxGen, a pharmaceutical company based in the United States. Though 5,400 participants are enrolled, less than 10% are women. Multi-site vaccine preparedness studies have demonstrated that at-risk women, many of whom are low-income and disenfranchised, are willing to enroll in HIV vaccine trials and can be successfully recruited and retained over time. Other work shows that high risk women with limited formal education can be taught to comprehend HIV vaccine trial information to facilitate informed consent. What is more controversial is whether the HIV incidence rate among U.S. women is sufficient to warrant their participation in vaccine trials. Unfortunately, few cohort studies which measure HIV incidence in U.S. women exist and these may not tap into those at highest risk. It is essential that those most at risk of HIV infection be included in cohort studies that estimate HIV incidence to assure women’s full participation in future vaccine trials. Vaccine trial participation is integral to finding an efficacious vaccine against HIV that will be appropriate for women.
Learning Objectives: 1. Identify the three essential elements needed to implement an efficacy trial for HIV preventive vaccines. 2. Recognize the unique challenges women bring to vaccine trial participation. 3. Assess whether there is sufficient data on women in the U.S. to warrant their participation in vaccine trials
Keywords: Women, Clinical Trails
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: VaxGen (Pharmaceutical Company)
I have a significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.
Relationship: I am a Research Scientist at the New York Blood Center, one of many sites conducting an efficacy trial of AIDSVAX, a preventive HIV vaccine candidate made by VaxGen.