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临床试验/NCT03228069
NCT03228069Unknown不适用

Humoral and Cell-mediated Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults

Queen Saovabha Memorial Institute2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Rabies Neutralizing Antibody Titers (RNab)

研究概览

简要总结

To study the humoral and cell-mediated immune responses in HIV-infected adults who had previously received rabies booster vaccination more than a year before

详细描述

Previous study has shown the higher immunogenicity response among HIV-infected adults who received a single visit 4-site intradermal rabies booster vaccination than those who received the conventional intramuscular regimen. The investigators follow the persistence of these effects. Also, the regulatory T cell levels were examined after the rabies booster vaccination .

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy HIV-infected adults
  • Previously received rabies booster vaccination by participation in the previous clinical trials of the investigators.

排除标准

  • Have any active opportunistic infections
  • Received blood or blood product within 3 months
  • Received anti-malarial drugs
  • Received rabies vaccination in a previous year.

结局指标

主要结局

Rabies Neutralizing Antibody Titers (RNab)

时间窗: GMTs of RNab and proportion of volunteers who have had RNab above protective antibody levels (0.5 IU/ml) after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.

Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)

次要结局

  • Rabies specific T cell response(Numbers of spots, of which represent the rabies specific T cell response after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.)

研究者

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

Suda Sibunruang

Medical doctor

Queen Saovabha Memorial Institute

研究点 (2)

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