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Be A Hero Vaccine Preparedness Study |
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Are US populations appropriate for trials of human immunodeficiency virus vaccine? The HIVNET Vaccine Preparedness Study.
Source:
Am J Epidemiol 2001 Apr 1;153(7):619-27
Authors:
Seage GR 3rd, Holte SE, Metzger D, Koblin BA, Gross M, Celum C, Marmor M, Woody G,
Mayer KH, Stevens C, Judson FN, McKirnan D, Sheon A, Self S, Buchbinder SP.
Publication Info:
Abt Associates Inc., Cambridge, MA, USA. gseage@hsph.harvard.edu
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Abstract:
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.
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