NCT00124865撤回1 期
Safety and Immunogenicity Evaluation of an Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine (rFla-MBP) in Volunteers
U.S. Army Medical Research and Development Command1 个研究点 分布在 1 个国家开始时间: 2005年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Systemic immunogenicity
研究概览
简要总结
This study is an open-labeled dose escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses.
详细描述
This is an open labeled dose escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses according to the following chart:
Group / N* / rFla-MBP
A / 8/ 25 micrograms
B / 8/ 125 micrograms
C / 8/ 625 micrograms
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult
- •70% accuracy on comprehension test
- •Availability for required visits and telephone follow up
排除标准
- •Pregnancy or breastfeeding
- •Chronic health problems
- •Abnormalities found on physical examination
- •Use of immunosuppressive drugs, such as corticosteroids or chemotherapy
- •Positive blood test for HIV-1, hepatits B surface antigen (HBsAG) or hepatitis C virus (HCV)
- •Abnormalities found on basic laboratory screening
- •Prior exposure to Campylobacter
- •Current smoker
- •Chronic sinusitis or seasonal rhinitis
结局指标
主要结局
Systemic immunogenicity
Local and systemic reactions
Mucosal immunogenicity
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin LymphomaClassical Hodgkin LymphomaNon-Hodgkin LymphomaNCT06018129Genmab9
撤回
1 期
Safety Study of Intravitreal EBI-031 Given as a Single or Repeat Injection to Subjects With Diabetic Macular EdemaDiabetic Macular EdemaNCT02842541Eleven Biotherapeutics
已完成
2 期
Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis ImperfectaOsteogenesis ImperfectaNCT01417091Ultragenyx Pharmaceutical Inc10
已完成
1 期
Open Label, Dose Escalation Study for the Safety and Efficacy of STP705 in Adult Patients With isSCCCutaneous Squamous Cell Carcinoma in SituBowen's DiseaseNCT04293679Sirnaomics25
已完成
1 期
A Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 and HIV-1 Trimer 6931 Vaccines in Healthy AdultsHIVNCT05470400National Institute of Allergy and Infectious Diseases (NIAID)44