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Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins

2018年4月5日更新者：Suda Sibunruang、Queen Saovabha Memorial Institute

Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins for Post-exposure Rabies Treatment

Reduced 4-dose intramuscular rabies vaccination schedule was announced by US-ACIP and WHO to be one of the post-exposure prophylaxis regimens. However, concurrent usage of this regimen with rabies immunoglobulin have never been studied in the aspect that the immunity level would above the protective level required by WHO (0.5 IU/ml) for at least a year period. This study would access this subject.

研究概览

地位

完全的

条件

狂犬病

干预/治疗

生物：rabies vaccine

详细说明

Controlled trial study
All 75 volunteers who had never had rabies immunization would be enrolled and designated into 3 groups.

group 1 : 25 Healthy volunteers age 18 - 60 yr who were attacked by mammals, possible exposed to rabies and had WHO category III exposure, all receive standard post - exposure rabies treatment with 5-dose intramuscular rabies vaccine on day 0,3,7,14,28 and 40 IU/kg of equine rabies immune globulin (ERIG).

group 2 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,14 and 40 IU/kg of equine rabies immune globulin (ERIG).

group 3 : 25 Healthy volunteers age 18 - 60 yr receive 4-dose intramuscular rabies vaccine on day 0,3,7,28 and 40 IU/kg of equine rabies immune globulin (ERIG).

5 cc - Blood would be drawn from all volunteers before vaccination and on day 14, 28, 90 and 360 for rabies neutralizing antibody titers (RNab).

The GMTs of RNab among both groups would be analyzed and compared.

研究类型

介入性

注册 (实际的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

泰国
- - Bangkok、泰国、10330
    - Queen Saovabha Memorial Institute

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 60年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

healthy volunteers age 18-60 years.

Exclusion Criteria:

received prior rabies immunization
pregnancy
immunocompromised conditions

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：预防
分配：非随机化
介入模型：并行分配
屏蔽：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Rabies vaccine, IM day 0,3,7,28 with RIG Healthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 28 with equine rabies immunoglobulin 40 IU/Kg on day 0.	生物：rabies vaccine Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0. Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0. Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0. 其他名称： Equine rabies immunoglobulin produced by Thai Red Cross
实验性的：Rabies vaccine, IM day 0,3,7,14 with RIG Healthy volunteers received rabies vaccination intramuscularly on day 0,3,7 and 14 with equine rabies immunoglobulin 40 IU/Kg on day 0.	生物：rabies vaccine Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0. Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0. Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0. 其他名称： Equine rabies immunoglobulin produced by Thai Red Cross
有源比较器：Rabies vaccine, IM Day 0,3,7,14,28 with RIG Rabies exposed victims receive rabies vaccination intramuscularly on Day 0,3,7,14,28 with equine rabies immunoglobulin 40 IU/Kg on day 0	生物：rabies vaccine Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0. Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0. Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0. 其他名称： Equine rabies immunoglobulin produced by Thai Red Cross

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14 大体时间：Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period	Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,14 would be determined on day 0,14, 28, 90 and 360. Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.	Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period

次要结果测量

结果测量	措施说明	大体时间
Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7,28 大体时间：Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period	Rabies Neutralizing antibody titers in volunteers who receive rabies vaccination on day 0,3,7 and 28 would be determined on day 0,14, 28, 90 and 360. Rnab titers above 0.5 IU/ml would be considered as protective levels as WHO recommendation.	Change from baseline of Rabies Neutralizing Antibody Titers at 1 year period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Queen Saovabha Memorial Institute

调查人员

首席研究员：Suda Sibunruang, MD、Queen Saovabha Memorial Institute

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年9月1日

初级完成 (实际的)

2018年4月1日

研究完成 (实际的)

2018年4月1日

研究注册日期

首次提交

2012年7月12日

首先提交符合 QC 标准的

2012年7月12日

首次发布 (估计)

2012年7月16日

研究记录更新

最后更新发布 (实际的)

2018年4月6日

上次提交的符合 QC 标准的更新

2018年4月5日

最后验证

2018年4月1日

Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins