Open AccessAre US Populations Appropriate for Trials of Human Immunodeficiency Virus Vaccine?
Author(s) -
George R. Seage,
Sarah Holte,
David Metzger,
Beryl A. Koblin,
Michael L. Gross,
Connie Celum,
Michael Marmor,
George Woody,
Kenneth H. Mayer,
Cladd E. Stevens,
Franklyn N. Judson,
David J. McKirnan,
Amy R. Sheon,
Steven G. Self,
Susan Buchbinder
Publication year - 2001
Publication title -
american journal of epidemiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.33
H-Index - 256
eISSN - 1476-6256
pISSN - 0002-9262
DOI - 10.1093/aje/153.7.619
Subject(s) - medicine , human immunodeficiency virus (hiv) , hiv vaccine , confidence interval , incidence (geometry) , cohort , demography , men who have sex with men , prospective cohort study , cohort study , vaccine trial , immunology , syphilis , physics , sociology , optics
Questions exist about whether testing of preventive human immunodeficiency virus (HIV)-1 vaccines, which will require rapid recruitment and retention of cohorts with high HIV-1 seroincidence, is feasible in the United States. A prospective cohort study was conducted in 1995-1997 among 4,892 persons at high risk for HIV infection in nine US cities. At 18 months, with an 88% retention rate, 90 incident HIV-1 infections were observed (1.31/100 person-years (PY), 95% confidence interval (CI): 1.06, 1.61). HIV-1 seroincidence rates varied significantly by baseline eligibility criteria--1.55/100 PY among men who had sex with men, 0.38/100 PY among male intravenous drug users, 1.24/100 PY among female intravenous drug users, and 1.13/100 PY among women at heterosexual risk-and by enrollment site, from 0.48/100 PY to 2.18/100 PY. HIV-1 incidence was highest among those men who had sex with men who reported unprotected anal intercourse (2.01/100 PY, 95% CI: 1.54, 2.63), participants who were definitely willing to enroll in an HIV vaccine trial (1.96/100 PY, 95% CI: 1.41, 2.73), and women who used crack cocaine (1.62/100 PY, 95% CI: 0.92, 2.85). Therefore, cohorts with HIV-1 seroincidence rates appropriate for HIV-1 vaccine trials can be recruited, enrolled, and retained.