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Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults

Phase I Study of the Safety and Immunogenicity of rDEN1delta30, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue Serotype 1

Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults.

研究概览

地位

完全的

条件

详细说明

More than 2 billion people living in tropical and subtropical regions of the world are at risk of dengue virus infection. Dengue viruses cause dengue fever, as well as the more severe dengue hemorrhagic fever/shock syndrome, and dengue virus infection is the leading cause of hospitalization and death in children in several tropical Asian countries. This study will evaluate the safety and immunogenicity of a live, attenuated dengue virus called rDEN1delta30, which is derived from the Western Pacific DEN1 serotype.

This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive rDEN1delta30 or placebo at study entry. Cohort 2 will begin only after safety review of all participants in Cohort 1. Participants in Cohort 2 will receive a higher dose of rDEN1delta30 or placebo.

After vaccination, participants will be asked to monitor their temperature every day for 16 days. Study visits will occur every other day after vaccination until Day 16, followed by 4 additional visits at selected days through Day 180. Blood collection and a targeted physical exam will occur at each study visit. Some participants will be asked to undergo a skin biopsy or additional blood collection at selected visits.

研究类型

介入性

注册 (实际的)

28

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

    • Maryland
      • Baltimore、Maryland、美国、21205
        • Center for Immunization Research, Johns Hopkins School of Public Health

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

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Willing to be followed for the duration of the study
  • Willing to use acceptable methods of contraception
  • Good general health

Exclusion Criteria:

  • Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
  • Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
  • Liver, renal, or hematologic disease
  • Alcohol or drug abuse within 12 months of study entry
  • History of severe allergic reaction or anaphylaxis
  • Emergency room visit or hospitalization for severe asthma within 6 months of study entry
  • HIV-1 infected
  • HCV infected
  • Hepatitis B surface antigen positive
  • Known immunodeficiency syndrome
  • Use of corticosteroids or immunosuppressive drugs within 30 days of study entry. Participants who have used topical or nasal corticosteroids are not excluded.
  • Live vaccine within 4 weeks of study entry
  • Killed vaccine within 2 weeks of study entry
  • Blood products within 6 months of study entry
  • Investigational drugs or vaccines within 60 days prior to study entry or while currently enrolled in this clinical trial
  • Previously received a licensed or experimental yellow fever or dengue vaccine
  • Surgical removal of spleen
  • History of dengue virus infection or other flavivirus infection
  • Other condition that, in the opinion of the investigator, would affect the participant's participation in the study
  • Pregnancy or breastfeeding
  • Plan to travel to an area where dengue infection is common

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:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:1
One subcutaneous vaccination with rDEN1delta30 vaccine (10^3 PFU dose) into the deltoid region of either arm.
Live attenuated rDEN1delta30 vaccine
实验性的:2
One subcutaneous vaccination with rDEN1delta30 vaccine (10^5 PFU dose) into the deltoid region of either arm. This arm may enroll after Arm 1 depending on the effect of the vaccine on subjects in Arm 1.
Live attenuated rDEN1delta30 vaccine
安慰剂比较:3
One subcutaneous vaccination with placebo into the deltoid region of either arm.
RDEN1delta30 的安慰剂

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Determine the frequency of vaccine related AEs for each dose graded by severity
大体时间:Throughout study
Throughout study
Determine the amount of dengue 1 neutralizing antibody induced by the vaccine
大体时间:At Day 42
At Day 42

次要结果测量

结果测量
大体时间
评估抗体反应的持久性
大体时间:在第 180 天
在第 180 天
评估每个研究剂量队列中病毒血症的频率、数量和持续时间
大体时间:在整个学习过程中
在整个学习过程中
To compare the T cell mediated immune response against dengue viruses of those volunteers infected with the rDEN1delta30 vaccine virus with that of uninfected volunteers and placebo recipients
大体时间:Throughout study
Throughout study
If both doses of vaccine are administered, to compare the infectivity rates, safety, and immunogenicity between dose groups
大体时间:At study completion
At study completion
评估愿意接受皮肤活检的志愿者疫苗相关皮疹的免疫病理学机制
大体时间:在整个学习过程中
在整个学习过程中

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。

调查人员

  • 首席研究员:Anna Durbin, MD、Center for Immunization Research, John Hopkins School of Public Health

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

2004年9月1日

初级完成 (实际的)

2005年11月1日

研究完成 (实际的)

2005年11月1日

研究注册日期

首次提交

2004年8月17日

首先提交符合 QC 标准的

2004年8月18日

首次发布 (估计)

2004年8月19日

研究记录更新

最后更新发布 (估计)

2008年1月18日

上次提交的符合 QC 标准的更新

2008年1月17日

最后验证

2008年1月1日

更多信息

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.

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