Recruitment and baseline epidemiologic profile of participants in the first phase 3 HIV vaccine efficacy trial

Clayton D. Harro, Franklyn N. Judson, Geoffrey J. Gorse, Kenneth H. Mayer, Jay R. Kostman, Stephen J. Brown, Beryl Koblin, Michael Marmor, Bradford N. Bartholow, Vladimir Popovic

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To describe recruitment and baseline epidemiologic characteristics of volunteers in the first phase 3 placebo-controlled trial of a recombinant gp120 HIV vaccine (AIDSVAX B/B). Methods: Volunteers were gay/bisexual men or women at risk for sexually transmitted HIV infection. Recruitment strategies, demographics, and risk factors were assessed. HIV status was determined by standard HIV-1 antibody assays. Seronegative/viremic HIV infection at enrollment was determined using the HIV-1 nucleic acid test. Results: From June 1998 through October 1999, 5417 of 7185 volunteers screened were enrolled at 61 sites in the United States, Canada, and The Netherlands. Successful recruitment methods included distribution of study information at gay venues, advertising and media coverage, and referrals from volunteers. Most volunteers were altruistically motivated, men (98%), young (median, 36 years), white (83%), well educated (61% college education or more), and at high risk for HIV during the 6 months before enrollment. At baseline, 14 were HIV infected (12 were seronegative but viremic; 2 were seropositive and viremic). Conclusion: Men and women at high risk for sexually transmitted HIV infection were successfully recruited for the first phase 3 HIV vaccine efficacy trial. Knowledge of recruitment and baseline epidemiologic characteristics of participants in this trial will provide valuable guidance for designing and conducting future trials.

Original languageEnglish (US)
Pages (from-to)1385-1392
Number of pages8
JournalJournal of Acquired Immune Deficiency Syndromes
Volume37
Issue number3
DOIs
StatePublished - Nov 1 2004

Keywords

  • AIDSVAX B/B
  • Efficacy trial
  • HIV incidence
  • Risk factors
  • rgp120 HIV vaccine

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

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