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临床试验/NCT01259453
NCT01259453已完成4 期

Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules

Yale University6 个研究点 分布在 1 个国家目标入组 595 人开始时间: 2003年5月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
595
试验地点
6
主要终点
Vaccine Efficacy

研究概览

简要总结

The investigators seek to provide immunization for individuals who are at high risk of contracting hepatitis B virus (HBV) infection because of their illicit drug use. The investigators will be using the syringe exchange programs (SEPs) in Hartford and Bridgeport, CT and Chicago, IL to contact high risk individuals and refer them for vaccination. The primary purpose of the study is to compare the standard schedule of hepatitis B vaccination at 0, 1, and 6 months to an accelerated schedule of vaccination at 0, 1, and 2 months. The investigators hypothesize that the accelerated scheduling will result in improved completion rates without significant loss in vaccine efficacy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Demonstrate evidence of recent injection drug use (injection stigmata),
  • 18 years of age or older,
  • Screened for and found susceptible to HBV
  • Able to provide informed consent.

排除标准

  • Evidence of intoxication that prevented provision of informed consent.

结局指标

主要结局

Vaccine Efficacy

时间窗: 8 months from study enrollment

次要结局

  • Vaccine completion rate(8 months from study enrollment)
  • Association of exchange status with completion(8 months from study enrollment)

研究者

申办方类型
Other

研究点 (6)

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