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


CONCLUSIONS
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.
The Johns Hopkins Bloomberg School of Public Health, Center for Immunization Research, Baltimore, Maryland 21205, USA. charro@jhsph.edu
Clayton D
CD
Harro
Franklyn N
FN
Judson
Geoffrey J
GJ
Gorse
Kenneth H
KH
Mayer
Jay R
JR
Kostman
Stephen J
SJ
Brown
Beryl
B
Koblin
Michael
M
Marmor
Bradford N
BN
Bartholow
Vladimir
V
Popovic
D016915:AIDS Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D000163:Acquired Immunodeficiency Syndrome / Q000276:immunology*; D000328:Adult; D000533:Altruism; D001727:Bisexuality; D004311:Double-Blind Method; D004522:Educational Status; D005260:Female; D015658:HIV Infections / Q000276:immunology*; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D018579:Patient Selection; D010919:Placebos; D012017:Referral and Consultation; D018570:Risk Assessment; D014766:Viremia / Q000276:immunology
D016915:AIDS Vaccines; D010919:Placebos