NCT00582504Unknown2 期
A Phase 2 Open-Label, Safety and Immunogenicity Study of a Single Dose of Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried, TC-83, NDBR-102, as Primary Immunization in Healthy Adults At Risk for Exposure to Virulent Venezuelan Equine Encephalomyelitis Virus
U.S. Army Medical Research and Development Command2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2007年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Number of participants with a 80% plaque-reduction neutralization titer (PRNT80)
研究概览
简要总结
This study is designed to determine safety of and immune response to Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried TC-83, NDBR-102 (TC-83).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old
- •VEE PRNT80 < 1:10 before immunization.
- •(females) Negative serum pregnancy test on same day before vaccination. Not planning pregnancy for 3 months.
- •Actively enrolled in the SIP
- •At risk for exposure to virulent VEE virus (with up-to-date risk assessment).
- •Up-to-date (within 1 year) physical examination/tests.
- •Sign and date the approved informed consent.
- •Willing to return for all follow-up visits.
- •Agree to report adverse event (AE) up to 28 days after vaccination.
排除标准
- •Over age of 65 years.
- •Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated liver function tests.
- •History of immunodeficiency or current treatment with immunosuppressive medication.
- •(females) Currently breastfeeding.
- •Confirmed human immunodeficiency virus (HIV) titer.
- •Family history (first degree relative, but not elderly parent with late onset) diabetes, personal history gestational diabetes, or confirmed elevated fasting serum glucose (> 125 mg/dL).
- •Serious allergic reaction to guinea pigs/guinea pig products.
- •Any known allergies to components of the vaccine.
- •A medical condition that in the judgment of the Principal Investigator (PI) would impact subject safety (i.e-vaccination and or exposure to another alphavirus).
- •Administration of any vaccine within 28 days of TC-
- •Any unresolved AEs resulting from a previous immunization.
结局指标
主要结局
Number of participants with a 80% plaque-reduction neutralization titer (PRNT80)
时间窗: 21-35 days, 42-56 days, 12-15 months
Number of adverse events.
时间窗: 7 years
次要结局
- Number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT 80 ≥ 1:20.(7 years)
研究者
研究点 (2)
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