临床试验/NCT02289794

NCT02289794已完成1 期

Evaluation of a Candidate Vaccine Against Uropathogenic Escherichia Coli in Women With a Clinical History of Recurrent Urinary Tract Infection

GlycoVaxyn AG1 个研究点分布在 1 个国家目标入组 194 人开始时间: 2014年1月1日最近更新: 2016年2月11日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: GlycoVaxyn AG
入组人数: 194
试验地点: 1
主要终点: Number of subjects experiencing an adverse events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This Phase I multi-center placebo controlled study is conducted in healthy women with a history of recurrent urinary tract infections (UTI) aged between 18 and 70 years.

详细描述

GlycoVaxyn is a Swiss company that has developed a multivalent bioconjugate vaccine for the prevention of E.coli-infections. Cystitis is the most common UTI, however kidney infections or bacteremia are possible. The E. coli bacterium is responsible for 85 % of all UTIs.

The objectives of this trial are to assess the safety and ability to elicit an immune response of the candidate vaccine as well as the effectiveness of the vaccine in the reduction in UTIs .

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: Single (Participant)

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Female subjects with a history of recurrent UTI, which is defined as: ≥ 3 UTI independent episodes in the previous 12 months or ≥ 2 UTI episodes in the last 6 months. At least one UTI during the last 5 years was caused by E. coli (as single pathogen or part of polymicrobial infection) and was culture-confirmed and documented
•Age ≥ 18 and ≤ 70 years
•Subjects should be in a healthy state without ongoing or suspected symptomatic UTI at the screening visit and at injection day (V2)
•General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of the investigator
•Willingness to participate in the study after all aspects of the protocol have been explained and fully understood, and written informed consent form obtained

排除标准

•History of more than 10 recurrent UTIs in the year before the screening visit
•Use of any short-term urinary catheter within 7 days prior to screening
•Use of any permanent catheter within 30 days prior to screening
•History of any unresolved urinary tract diseases/abnormalities
•Evidence of impaired immune function
•Significant cardiovascular, liver, renal diseases and/or insufficiency
•Uncontrolled diabetes mellitus
•Significant abnormalities in screening results for hematology, serum chemistry or urinalysis
•Positive test for HIV, and/or evidence of HBV or HCV
•Previous immune stimulatory therapy for UTI prevention (such as Urovaxom®, Strovac® or Urovac®) in the last 3 months, or planned use during the study period
•Current use of any medication known to affect immune function (e.g. corticosteroids ≥0.5 mg/kg Body weight/day)
•Use of UTI-related vaginal estrogen treatment newly started less than 6 months before injection and continuing during the study or planned start during the active study period
•Use of any antibiotic therapy within 1 week preceding injection
•Planned use of post-coital antibiotics for UTI prevention during study period
•Any vaccination planned within 30 days before and 30 days after injection
•Participation in other clinical trials in the 60 days preceding enrolment and for the duration of the study
•Previous treatment with immunoglobulins or blood products in the 3 months preceding the injection
•Known hypersensitivity to any component of the vaccine
•Presence of a significant medical or psychiatric condition that in the opinion of the investigator precludes participation in the study
•Acute illness at the time of injection
•Women of child bearing potential who either have a positive pregnancy test or refuse to use an effective contraception
•Women who are lactating at any time throughout the study period
•Subjects with an elective surgical intervention, planned during the study period
•Any other significant finding that in the opinion of the Investigator would increase the risk of having an adverse outcome from participating in the study

研究组 & 干预措施

E.coli bioconjugate vaccine

Active Comparator

E.coli bioconjugate vaccine in saline buffer

干预措施: E.coli bioconjugate vaccine (Biological)

Placebo

Placebo Comparator

Saline buffer

干预措施: Placebo (Biological)

结局指标

主要结局

Number of subjects experiencing an adverse events

时间窗: 30 days

Occurrence, intensity, relationship and duration of solicited and unsolicited adverse events (AE) and serious adverse events (SAE) post injection of candidate vaccine compared to the placebo group

次要结局

Comparison of E.coli vaccine-specific serotypes antibody concentrations in serum at different timepoints(30 days and 9 months)

研究者

发起方

GlycoVaxyn AG

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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