Are US populations appropriate for trials of human immunodeficiency virus vaccine? The HIVNET Vaccine Preparedness Study.
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.
Abt Associates Inc., Cambridge, MA, USA. gseage@hsph.harvard.edu
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Seage
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Holte
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Metzger
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Koblin
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Gross
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Celum
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Marmor
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Woody
K H
KH
Mayer
C
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Stevens
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FN
Judson
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McKirnan
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A
Sheon
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Self
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Buchbinder
D016915:AIDS Vaccines / Q000008:administration & dosage*; D000163:Acquired Immunodeficiency Syndrome / Q000453:epidemiology; D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D015331:Cohort Studies; D016001:Confidence Intervals; D004196:Disease Outbreaks / Q000517:prevention & control*; D015340:Epidemiologic Research Design; D005240:Feasibility Studies; D005260:Female; D015658:HIV Infections / Q000453:epidemiology*; D006679:HIV Seropositivity; D006801:Humans; D015994:Incidence; D008297:Male; D018579:Patient Selection; D011446:Prospective Studies; D012044:Regression Analysis; D012307:Risk Factors; D017678:Sex Distribution; D014481:United States / Q000453:epidemiology
D016915:AIDS Vaccines