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VaxGen AIDSVAX B/B Vaccine Trial: Recruitment, Demographics, and Changes in Risk Behaviors - Lessons for Future Trials.

Brown SJ, Harro C, Mayer KH, Bartholow BN, Buchbinder S, Mastro TD, Judson F, Gorse GJ, Kostman J, Koblin B, Marmor M, Celum C, Goli V, Popovic V, Para M, Novak RM, McKirnan DJ, Creticos C, Orozco-Cronin P; National HIV Prevention Conference (2003 : Atlanta, Ga.).

Abstr Book 2003 Natl HIV Prev Conf July 27 30 2003 Hyatt Regency Atlanta Hotel Atlanta Ga Natl HIV Prev Conf 2003 Atlanta Ga. 2003;null:abstract no. T3-D0502.

AIDS ReSearch Alliance, West Hollywood, CA

BACKGROUND/OBJECTIVES: Earlier this year, the results of the first phase III placebo controlled trial of an preventative HIV vaccine were released (AIDSVAX-B/B). Before the study was begun, there were concerns about the ability to recruit and retain the large cohort required to conduct the study, and whether participation in such a trial would be associated with increased risk activity. Here we describe baseline epidemiological characteristics, recruitment sources and the self-described motivations of patients participating in this first phase III efficacy trial of an HIV vaccine. We also examine changes in sexual risk behavior over the 36 months of trial follow-up.METHODS: 61 centers primarily in North America were engaged in the conduct of this clinical trial. Demographics, risk factors, and successful recruitment techniques and strategies were assessed. HIV risk activity assessments and risk reduction counseling were conducted at each study visit. Volunteers were also queried for their perception of group assignment, i.e., vaccine or placebo.RESULTS: Over a 17 month period, 7,185 volunteers were screened. 5417 HIV negative volunteers were enrolled (5,108 men who have sex with men (MSM), and 309 high risk women). Most participants were altruistically motivated (98%), young (median age 36), well educated (61% college or higher) and at high risk for HIV infection in the 6 months prior to enrollment. Retention in the trial was high (83%). Transfer procedures allowed approximately 10% of the volunteers to move and yet continue study participation at another site. Over the 3 years of the study the seroconversion rate was 5.76%. Overall there was a decrease in risk behavior from baseline which was maintained throughout the study. But reductions in HIV risk behaviors were not as well maintained in younger patients and those consistently believing that they were receiving vaccine (as opposed to being unsure or believing they were receiving placebo.) CONCLUSIONS: This large study was rapidly recruited and retention was higher than anticipated. A significant percentage of patients recruited to this trial needed to relocate but were able to continue participation at other sites which were widely dispersed geographically. The seroconversion rate in the trial attested to the successful recruitment of high risk subjects. Although overall there was a reduction in risk behavior, some demographic variables and perceptions of group assignment (vaccine vs placebo) highlight theneed for vigilance regarding continuing risk reduction counseling, and educational processes in the context of HIV vaccine trials. The information gleaned from this first large phase III trial of an HIV vaccine, as well as continuing additional data analysis of the trial should help guide the design and execution of future HIV vaccine studies. These trial results may also have implications for future studies of microbicides.

Publication Types:

  • Meeting Abstracts

Keywords:

  • AIDS Vaccines
  • AIDSVAX
  • Adolescent
  • Adult
  • Aged, 80 and over
  • Cohort Studies
  • Counseling
  • Demography
  • Female
  • Follow-Up Studies
  • HIV Infections
  • HIV Seropositivity
  • Humans
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Motivation
  • North America
  • Risk Assessment
  • Risk-Taking
  • Sexual Behavior
  • Young Adult

Other ID:

  • GWAIDS0022447

General Notes:

  • Meeting held in: United States

NLM Unique ID: 101188512
UI: 102262071
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Last Updated: May 20, 2014