NCT00103467已完成1 期
A Phase 1 Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine
VaxGen8 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2003年6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
- 100
- 试验地点
- 8
- 主要终点
- Safety and immunogenicity of 3 doses over 4 different dose ranges.
研究概览
简要总结
The purpose of this phase 1 study is to evaluate the safety and immunogenicity of rPA102 vaccine, using anthrax vaccine adsorbed (AVA) as a comparator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to understand the study and give written informed consent. A signed informed consent must be in place before the initiation of any study interventions.
- •Healthy male or female aged 18 to 40 years old (inclusive) without significant physical or clinical laboratory abnormalities.
- •Two intact upper arms with sufficient intramuscular (IM) tissue in the deltoid region for vaccine administration.
- •For females, negative serum pregnancy test at screening and agreement to use adequate birth control during the first 3 months of the study.
- •Willingness and ability to return for all follow-up visits and blood draws for the duration of the study.
- •Willingness to complete the Volunteer Diary and to report concomitant medications and adverse events (AEs) to the study site monitors during the study period.
排除标准
- •Prior history of, or known exposure to any form of B. anthracis or any anthrax immunization.
- •Member of the Armed Services (Active Duty or Reserve) since 1990, with history of previous anthrax vaccination.
- •Employment in an industry involved in contact with ruminant animals, veterinary sciences, or other exposure to B. anthracis.
- •Expected to be noncompliant with study visits or planning to move within 8 months.
- •Body mass index of >35 or <
- •Known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, latex, kanamycin, or any other aminoglycoside antibiotics (such as gentamycin).
- •Pregnancy (positive urine pregnancy test within 24 hours prior to vaccination), or lactation.
- •HIV positive (by history or screening ELISA).
- •Hepatitis B or C positive (by history or screening HBsAg/anti-HCV ELISA).
- •Active or past internal organ, hematologic malignancy, or metastatic cutaneous malignancy.
- •History of, or current autoimmune disease, including but not limited to systemic lupus erythematosus, scleroderma, and polyarteritis.
- •Immunodeficiency or unstable medical condition as determined by baseline medical history, physical exam, and laboratory assessment.
- •Received, or plans to receive, licensed live vaccines within 30 days of study vaccination.
- •Received, or plans to receive, licensed killed vaccines within 14 days of study vaccination.
- •Received, or plans to receive, immunoglobulin or other blood products within 60 days of study vaccination.
- •Received, or plans to receive, experimental drugs/vaccines within 30 days of study vaccination.
- •Received, or plans to receive, systemic immunosuppresive therapy, radiation therapy, or high-dose inhaled steroids within 30 days of study vaccination.
- •Use of systemic chemotherapy within 5 years prior to study.
- •History of Guillain-Barre Syndrome.
- •In addition to the conditions listed above, the following may qualify as a reason to exclude a volunteer from the study: fever along with moderate or serious illness within 3 days of vaccination or any condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the study evaluations. Pending resolution of these symptoms, a volunteer may be reconsidered for vaccination.
结局指标
主要结局
Safety and immunogenicity of 3 doses over 4 different dose ranges.
次要结局
未报告次要终点
研究者
研究点 (8)
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