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临床试验/NCT01286493
NCT01286493已完成不适用

Immune Response After Booster Vaccination in HIV - Infected Patients Who Ever Received Rabies Primary Vaccination

Queen Saovabha Memorial Institute2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
Rabies Neutralizing Antibody Titers

研究概览

简要总结

Booster rabies vaccination in HIV - infected patients who have ever received rabies primary vaccination could improve their immune response to this kind of vaccine.

详细描述

The investigators have learned from the previous studies that some HIV-infected patients especially those with low CD4+ T-lymphocyte count had poor antibody response to rabies vaccination. Because of the role of the memory B cell, the investigators hypothesized that primary rabies immunization in HIV-infected patients could rise rapid anamnestic antibody response to ones after booster vaccination in case of re-exposure of rabies occur despite of their immunocompromised state.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • HIV infected patients 18-60 years of age
  • Ever received primary rabies immunization

排除标准

  • currently have any active opportunistic infections
  • have received blood or blood product within previous 3 months
  • history of allergy to vaccine or any vaccine components
  • currently received anti-malarial drugs

结局指标

主要结局

Rabies Neutralizing Antibody Titers

时间窗: Day 360

Rabies Neutralizing Antibody titers(RNab)of HIV-infected patients who receive booster rabies vaccination would be measured by Rapid Fluorescent Focus Inhibition Test(RFFIT) method at day 0, 7, 14, 28, 90,180 and 360. RNab level above 0.5 IU/ml indicate acceptable protective antibody response. for 7 times in 1 year.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suda Sibunruang

Principal investigator

Queen Saovabha Memorial Institute

研究点 (2)

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