Issue No. 5

Underrepresentation of Ethnic Minority Participants in HIV Vaccine Trials

In 2005, the Centers for Disease Control and Prevention (CDC) reported that African-Americans represent only 13% of the total U.S. population, yet account for 49% of all AIDS cases. According to the CDC, HIV/AIDS is the leading cause of death for African- Americans ages 25 to 44. There’s no disputing that minorities are among those in greatest need of an HIV vaccine.

In spite of these statistics, a recent study, “HIV Vaccine Trial Participation Among Ethnic Minority Communities: Barriers, Motivators, and Implications for Recruitment ,” found that ethnic minority populations are underrepresented in HIV vaccine trials. The study also examined perceived obstacles and motivations for HIV vaccine trial participation among low-socioeconomic minority respondents at risk of HIV infection.

Among the apparent barriers to HIV vaccine trial participation were fear of vaccine-induced HIV infection, physical side effects, uncertainty about a vaccine's efficacy, uncertainty of other vaccine characteristics, mistrust of government-sponsored medical research, perceived low risk of HIV infection, study demands, stigma, and vaccine-induced HIV seropositivity. In the summer of 2006, a National Institute of Allergy and Infectious Disease (NIAID) press release revealed surprising survey results that support these data about attitudes and beliefs about HIV vaccine trials.

Most often, ethnic minorities who did participate in trials were motivated by altruistic intentions, monetary incentives, the perception that they would gain protection from HIV infection, and free insurance and/or medical care, according to the “HIV Vaccine Trial Participation Among Ethnic Minority Communities: Barriers, Motivators, and Implications for Recruitment” study.

See the AIDSinfo National Black HIV/AIDS Awareness Day page for links to more information on current vaccine research, health disparities, and HIV/AIDS statistics for the African-American population.

FDA Grants Fast Track Status to VivaGel Microbicide

VivaGel, an investigational vaginal microbicide that may prevent HIV and genital herpes, has received “Fast Track” status from the U.S. Food and Drug Administration (FDA). The Fast Track drug development program aims to speed up review and approval of drug products that serve an unmet medical need for serious or life-threatening conditions. Under the Fast Track program, data from clinical trials of VivaGel can be submitted to the FDA as the information becomes available, potentially shortening the time to FDA approval.

Phase I clinical trials of VivaGel found that the product is safe and caused minimal side effects. Future clinical trials will determine if the microbicide gel successfully prevents HIV and genital herpes when applied directly to the vagina before intercourse.

To learn more about VivaGel, click here. The National Institute of Allergy and Infectious Disease provides a booklet on microbicide research here.