NCT01369862已完成1 期
Randomised, Double-blind, Placebo-controlled, Phase I/II Study of Single Dose GHB16L2 Trivalent Influenza Vaccine in Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of participants with Adverse Events
研究概览
简要总结
The purpose of this phase I/II trial is to evaluate safety and tolerability of a single dose of GHB16L2 administered by liquid nasal spray for vaccination against seasonal influenza virus infection. It is also performed to assess immunogenicity and pharmacokinetics (shedding).
详细描述
GHB16L2 intends to provide a novel vaccination for influenza virus infection. 80 healthy volunteers will be included at a ratio of 1:1 for GHB16L2 or placebo. GHB16L2 will be administered once on day 1. Follow-up visits will be performed on days 2, 8 and 29.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers, 18-60 years
- •Seronegative for one or two of the applied vaccine strains
- •Low antibody titres for H1N1v
- •Written informed consent to participate in this study
- •For female volunteers of childbearing potential, provision of a history and current use of reliable contraceptive practices
排除标准
- •Acute febrile illness (>37.3°C)
- •Signs of acute or chronic upper or lower tract respiratory illnesses
- •History of severe atopy
- •Seasonal influenza vaccination in 2008/2009 and/or later seasons and/or pandemic influenza vaccination at any time
- •Fever ≥38.0°C in the time period between the pre-screening visit and day 1
- •Known increased tendency of nose bleeding
- •Volunteers with clinically relevant abnormal paranasal anatomy
- •Volunteers with clinically relevant abnormal laboratory values
- •In female volunteers of childbearing potential, a positive urine pregnancy test
- •Simultaneous treatment with immunosuppressive drugs incl. Corticosteroids (≥2 weeks) within 4 weeks prior to study medication application
- •Clinically relevant history of renal, hepatic, GI, cardiovascular, haematological, skin, endocrine, neurological or immunological diseases
- •History of leukaemia or cancer
- •HIV or Hepatitis B or C seropositivity
- •Volunteers who underwent rhino or sinus surgery, or surgery of another traumatic injury of the nose within 30 days prior to application of study medication
- •Volunteers who have received antiviral drugs, treatment with immunoglobulins or blood transfusions, or an investigational drug within 4 weeks prior to study medication application
- •Volunteers who have received anti-inflammatory drugs 2 days prior to study medication application
- •Volunteers who are not likely to cope with the requirements of the study or with a significant physical or mental condition that may interfere with the completion of the study
结局指标
主要结局
Number of participants with Adverse Events
时间窗: From baseline to 30 days after end of study
次要结局
- Seroconversion rates at day 29(At day 29 (end of study))
- Determination of the presence of GHB16L2 in mucosal samples (viral recovery/shedding)(1 week post immunisation)
- Immune response factor at day 29(At day 29 (end of study))
研究者
研究点 (2)
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