Characteristics of volunteer participants in phase I HIV vaccine trials.

This study examines characteristics of volunteers participating in Phase I HIV vaccine trials. An understanding of these characteristics may assist in the recruitment of volunteers for future trials. Volunteer surveys from 232 participants were reviewed. A total of 95% of the volunteers were Caucasian, 69% were heterosexual, and 52% were women. Volunteers ranged in age from 19 to 60 years with a median age of 36. Among the volunteers, 73% knew someone who may have had AIDS or knew someone who was at risk for acquiring HIT: Volunteers cited personal and political reasons for participating in the vaccine trials. No "typical" volunteer was identified, supporting the belief that many factors affect a person's willingness to participate in such situations.

Key words: vaccine, HIT: research, volunteer

Introduction

More than 17 million people worldwide are estimated to be infected with HIV, the virus that causes AIDS (Merson, 1995). In the United States, 62% of the 513,486 persons reported to have AIDS through December 1995 have died (Centers for Disease Control and Prevention, 1995). AIDS is now the leading cause of death for persons 25 to 44 years of age in the United States (Centers for Disease Control and Prevention, 1996). HIV is a major public health concern, and although recent progress has been made in antiretroviral therapy, effective treatment may be available for only a small percentage of persons globally. Thus, for most people, HIV will remain a progressive illness with a high mortality rate. Although antiretroviral treatment eventually may be developed to control viral replication in a given individual, the control of epidemics historically has required prevention measures, particularly vaccines. The development of a preventive HIV vaccine holds the greatest promise for controlling the pandemic. The success of this endeavor is limited by three major factors: (a) scientific understanding of how to achieve vaccine-induced immunity to HIV, (b) incentives for industry participation in the vaccine development process, and (c) a sufficient number of people willing to volunteer for vaccine clinical trials. The purpose of this study is to examine characteristics of volunteers who participate in HIV vaccine trials. With this knowledge, recruitment and retention of volunteers may be enhanced as target populations are identified.

Background

The evaluation of candidate HIV vaccines is a priority for the National Institute of Allergy and Infectious Diseases, National Institutes of Health, which provides funding for Phase I and Phase II trials of candidate HIV vaccines in the United States. Testing safety and immunogenicity of candidate HIV vaccines has been in progress since 1988. Currently, there are six AIDS vaccine evaluation units (AVEUs) in the AIDS Vaccine Evaluation Group (AVEG) in the United States. They are located at Vanderbilt University, St. Louis University, the University of Alabama (Birmingham), the University of Washington (Seattle), Rochester University, and Johns Hopkins University. More than 2,000 volunteers have been enrolled by the AVEG in HIV vaccine research trials.

Volunteerism is an important force in the battle against HIV. Since the first reported cases of HIV, volunteer organizations have been established to assist people with HIV as well as their families and friends. There has been a great deal of research examining volunteer motivation in service organizations (Urger, 1991; Winniford, Carpenter, & Grider, 1995). Some research has been focused specifically on the motivation of volunteers who work directly with people affected by HIV (Omoto & Snyder, 1993; Schondel, Shields, & Orel, 1992). Although much attention has been given to volunteers who provide social services to people with AIDS, little attention has been given to volunteers for HIV vaccine research. A better understanding of the volunteers for HIV vaccine trials is important to the ongoing process of vaccine development. This article explores the characteristics of volunteers from the Vanderbilt University AVEU that may have affected their decision to participate in vaccine studies.

Only one previous report has specifically addressed the willingness of subjects likely to volunteer for HIV vaccine research who meet the criteria for Phase I HIV vaccine trials (Jenkins, Temoshok, & Virochsiri, 1995). The volunteers in that study were selected from a group in Thailand considered to be at low risk for HIV. Unfortunately, most of the queried respondents were unwilling to participate in a vaccine trial, noting that they would likely receive little personal benefit from participation. Westblom et al. …