EUCTR2004-001915-78-GB进行中（未招募）1 期
A Comparative Double Blind Placebo-Controlled Study of Immunogenicity and Safety of two doses 10 ^5 and 10^7 CFU of SC599 oral vaccine, a Live Attenuated Shigella dysenteriae 1 vaccine strain in Healthy Human Adult Volunteers » - Oral Shigella SC599 vaccine Phase 2a study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 111
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •·Adult volunteer 18 to 50 of age
- •·Volunteers who are in good health as determined by medical history, physical examination and clinical judgement.
- •·Women who agree to have a pregnancy test immediately before immunisation and to use effective contraception during the study period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Individuals who have hypersensitivity to ciprofloxacin
- •·Individuals who are found to have HLA-B27 tissue type at the time of initial screening
- •·Concomitant therapy with antibiotics, iron, zinc, H2-receptor antagonists or proton-pump inhibitors
- •·Individuals who have received any vaccine against Shigella, or had proven or suspected shigellosis (bloody diarrhoea with fever) within 6 months prior to study entry
- •·Individuals with a significant level of immunity against Shigella detected at the screening visit (defined as serum ELISA anti-LPS IgG antibody titre greater than 3 S.D. above the mean background activity of a bank of healthy human sera)
- •·A clinically significant amount of protein or haemoglobin in the urine sample at the screening visit
- •·A positive Shigella stool culture at the screening visit
- •·Individuals with a known impairment of immune function or those receiving immunosuppressive therapy (including systemic corticosteroids, inhaled or topical steroid preparations are not a non inclusion criterion)
- •·Individuals with acute infections (including fever >37,5°C - oral temperature - ) at the time of immunisation or any chronic disease
- •·Individuals who have received an investigational product within 30 days prior to entry
- •·Individuals who have persons living with them who in the opinion of the investigator may be at risk of disease if exposed to the vaccine strain or whose occupation may bring them into contact with persons at risk of disease or who are food handlers by occupation.
- •·Individuals with close household contact with child younger than 5 years or a person with immunodeficiency.
研究者
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