此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Safety and Immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP Vaccines in Malaria Endemic Areas

2012年10月2日 更新者:University of Oxford

Safety and Immunogenicity of Heterologous Prime-boost With the Candidate Malaria Vaccines AdCh63 ME-TRAP and MVA ME-TRAP in Healthy Adults in a Malaria Endemic Area

The purpose of this trial is to assess the safety and immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP candidate vaccines in healthy adult volunteers in a malaria endemic region. The regime proposed in this trial has protected non-immune volunteers against sporozoite challenge in clinical trials performed by Oxford, and so may be protective against naturally acquired infection in Kenya.The study population will comprise 30 healthy adult males aged 18-50.

The investigators do not propose to include a placebo group. At this stage the investigators objective is to describe the safety profile in a small number of individuals, and the confidence intervals for the proportion of individuals with a particular event would be too wide for meaningful comparison with a placebo group. Immunogenicity will be judged by comparison with baseline.

研究概览

研究类型

介入性

注册 (实际的)

30

阶段

  • 阶段1

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

      • Kilifi、肯尼亚、PO Box 43640, 00100
        • KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast

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 50年 (成人)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Consenting adult males aged 18-50 years in good health.
  • Will remain resident in the study area for the study duration

Exclusion Criteria:

  • Clinically significant history of the following conditions; skin disorder (eczema, etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
  • History of splenectomy
  • Haemoglobin less than 9.0 g/dl
  • Clinically significant abnormalities of laboratory screening tests (full blood count, ALT, creatinine levels, urine dipstick examination for blood and protein).
  • Blood transfusion within one month of the beginning of the study
  • History of vaccination with previous experimental malaria vaccines
  • Administration of any other vaccine or immunoglobulin within two weeks before vaccination.
  • Current participation in another clinical trial, or within 12 weeks of this study
  • Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
  • Likelihood of travel away from the study area
  • HIV positive.
  • History of contact dermatitis (due to the use of a potentially irritant disinfectant that may be present in trace amounts in the AdCh63 ME-TRAP vaccine, see the investigators brochure for details, attached)

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:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Group 1
Intramuscular arm
AdCh63 ME-TRAP 1x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intramuscularly
AdCh63 ME-TRAP 5x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intradermal
实验性的:Group 2
Intradermal arm
AdCh63 ME-TRAP 1x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intramuscularly
AdCh63 ME-TRAP 5x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intradermal

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
Safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya.
大体时间:Participants will be followed for the duration of the study, an expected average of 12 months
To assess safety and reactogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya by recording local and systemic solicited and unsolicited adverse events
Participants will be followed for the duration of the study, an expected average of 12 months

次要结果测量

结果测量
措施说明
大体时间
Immunogenicity of vaccines
大体时间:Participants will be followed for the duration of the study, an expected average of 12 months
To evaluate the immunogenicity of AdCh63 ME-TRAP followed by MVA ME-TRAP in adults in Kenya by assessing induced antibody and T cell response to the vaccine insert.
Participants will be followed for the duration of the study, an expected average of 12 months
Immunogenicity of Vaccines
大体时间:Participants will be followed for the duration of the study, an expected average of 12 months
To compare the use of intra-muscular and intra-dermal MVA ME-TRAP
Participants will be followed for the duration of the study, an expected average of 12 months

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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2010年6月1日

初级完成 (实际的)

2011年5月1日

研究完成 (实际的)

2011年5月1日

研究注册日期

首次提交

2011年6月10日

首先提交符合 QC 标准的

2011年6月21日

首次发布 (估计)

2011年6月23日

研究记录更新

最后更新发布 (估计)

2012年10月3日

上次提交的符合 QC 标准的更新

2012年10月2日

最后验证

2012年10月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • VAC040

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

AdCh63 ME-TRAP followed by MVA ME-TRAP的临床试验

3
订阅