NCT02991417终止1 期
Safety and Immunogenicity Study of a Clostridium Difficile Vaccine in Healthy Adult Volunteers
Simon M. Cutting0 个研究点目标入组 3 人开始时间: 2017年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
This clinical study is conducted to assess the safety and immunogenicity of a Clostridium difficile vaccine (CDVAX) in healthy adult volunteers.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Age: 18-50 years (limits included)
- •Body mass index within 18.5 and 29.9 kg/m²
- •Ability to read and comprehend study information
- •Non-smokers or light smokers (<4 cigarettes per day)
- •In good physical and mental health as determined by the following:
- •Complete medical history
- •Complete physical and neurological examination
- •Vital signs including blood pressure, heart rate, respiratory rate, and temperature
- •Standard 12-lead ECG
- •Clinical laboratory (biochemistry, haematology and urinalysis) tests. Blood and urine samples may be drawn up to 3 weeks prior to the baseline visit of the study provided all data are available and evaluated prior to administration of study drug. Values of laboratory results outside normal reference ranges may be acceptable if the investigator considers that they do not compromise the safety of the subjects or the conduct of the study.
- •Vital signs, clinical laboratory measurements, and ECG measurements may be repeated at the discretion of the investigator
排除标准
- •Evidence of C. difficile infection
- •Anti-C. difficile (Toxin A) immunoreactivity, suggesting previous C. difficile exposure
- •Diarrhoea, active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhoea
- •History of malignancy within 5 years
- •History of anaphylaxis, asthma or severe vaccine or allergic drug reaction
- •Known or suspected history of immunodeficiency, active or inactive immune-mediated or inflammatory disease
- •Receipt of antibiotic therapy, immunosuppressants, or corticosteroids within the previous 30 days
- •Vaccination within the previous 30 days (except for influenza vaccination)
- •Blood or organ donation within the previous 60 days
- •Evidence of clinically significant psychiatric, gastrointestinal, neurologic, neuromuscular, hepatic, pulmonary, cardiovascular, or renal disease (as judged by the investigator)
- •Use of prescription medication or regular use of over-the-counter medicines or herbal or dietary supplements. Acetaminophen/paracetamol may be used intermittently as needed for pain
- •History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse
- •Positive hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV)-1/2 antibodies
- •Participation in any other investigational drug or device study within 60 days prior to the first study drug administration
- •Relatives of, or staff directly reporting to the principal investigator
- •Vulnerable subjects
研究组 & 干预措施
CDVAX
Experimental
干预措施: CDVAX (Biological)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: First treatment up to end of treatment + 28 days (70 days after treatment start)
Measured by routine physical and laboratory evaluations, adverse event monitoring, ECG and neurological examination
次要结局
- Evaluation of specific mucosal and systemic immunity(First treatment up to end of treatment + 14 days (56 days after starting study drug))
研究者
Simon M. Cutting
Professor
Royal Holloway University
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