Are US populations appropriate for trials of human immunodeficiency virus vaccine? The HIVNET Vaccine Preparedness Study
Are US populations appropriate for trials of human immunodeficiency virus vaccine? The HIVNET Vaccine Preparedness Study
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DOI：
10.1093/aje/153.7.619
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发表时间：
2001-04-01
影响因子：
5
通讯作者：
Buchbinder, SP
中科院分区：
文献类型：
--
作者：
Seage, GR;Holte, SE;Buchbinder, SP
存在的问题是，在美国是否可以进行预防性人类免疫缺陷病毒（HIV）-1疫苗的测试，这将需要快速招募和保留HIV-1血清发生率高的队列。1995年至1997年，在美国9个城市的4,892名艾滋病毒感染高危人群中进行了一项前瞻性队列研究。18个月时，留存率为88%，观察到90例HIV-1感染事件（1.31/100人年（PY），95%置信区间（CI）：1.06，1.61）。根据基线合格性标准，HIV-I血清发生率存在显著差异-男男性行为者中为1.55/100 PY，男性静脉吸毒者中为0.38/100 PY，女性静脉吸毒者中为1.24/100 PY，异性恋风险女性中为1.13/100 PY-根据入组中心，从0.48/100 PY至2.18/100 PY。HIV-1感染率在那些与报告无保护肛交的男性发生性关系的男性中最高（2.01/100 PY，95% CI：1.54，2.63），明确愿意入组HIV疫苗试验的受试者（1.96/100 PY，95% CI：1.41，2.73）和使用快克可卡因的女性（1.62/100 PY，95% CI：0.92，2.85）。因此，可以招募、登记和保留具有适合HIV-1疫苗试验的HIV-1血清发生率的队列。
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-I 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.