NCT01159561已完成1 期
Phase 1 Study to Evaluate the Safety and Immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, Lot 3-1-92, In Healthy Adults
U.S. Army Medical Research and Development Command2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Subjects Reporting Adverse Events by Vaccination and Sex
研究概览
简要总结
This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number 3-1-92.
详细描述
Study Objectives:
Primary: To assess safety of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.
Secondary: To evaluate immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-55 years of age
- •In good health as determined by pertinent medical history, brief physical exam, vital signs, and clinical safety laboratory evaluations
- •Female: has a negative urine pregnancy test and is willing to use reliable form of contraception for the study duration
- •Negative HIV antibody screen, seronegative for HBsAg and Hepatitis C antibody
- •WEE, EEE, VEE, and CHIK PRNT80<1:10
- •Ability to comprehend abnd a willingness to sign an informed consent, which includes the HIPAA and a separate HIV consent form
- •Be willing to comply with all follow-up visits, testing, and AE reporting
排除标准
- •Participant in the USAMRIID SIP
- •Receipt of any other vaccine or investigational; drug within 30 days prior to study entry
- •Anticipates receipt of other vaccines for the duration of the study (influenza vaccination will be permitted but not within 28 days of WEE vaccination
- •Acute of chronic medical conditions, medications, or dietary supplements that, in the PI's opinion, would impair the subject's ability to respond to vaccination
- •Hypersensitivity to any vaccine
- •Allergic to any vaccine component: Human serum albumin, Neomycin
- •Receipt of or anticipates receipt of blood products during the study
- •Female: Pregnant or breastfeeding
- •Clinically significant abnormal laboratory tests (generally greater than or equl to 2 times the upper limit of normal as determined by the PI)
结局指标
主要结局
Subjects Reporting Adverse Events by Vaccination and Sex
时间窗: 28 days following each vaccination
次要结局
- Immunogenicity(Baseline and multiple dates throughout study)
研究者
研究点 (2)
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