NCT01922856已完成2 期
A Phase 2b Controlled Efficacy Study of Intradermally Delivered ETEC Fimbrial Tip Adhesin Vaccine Against Experimental Challenge With ETEC H10407 in Healthy Adult Volunteers
U.S. Army Medical Research and Development Command4 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2013年9月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- Number of prevented diarrhea episodes
研究概览
简要总结
The purpose of the study is to determine the efficacy of a vaccine against enterotoxigenic E. coli (ETEC)-caused diarrhea.
详细描述
The purpose of the study is to establish preliminary efficacy of dscCfaE administered with LTR192G by intradermal (ID) immunization in prevention of disease caused by a challenge with a CFA/I expressing ETEC strain (H10407).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female age 18 through 50 years (inclusive).
- •General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of PI.
- •Negative pregnancy test. Pregnancy at any time will result in not receiving any or additional investigational product. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. Female subjects unable to bear children must have this documented (eg, tubal ligation or hysterectomy) or must have negative pregnancy tests.
- •Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
- •Completion of a training session and demonstrated comprehension of the protocol procedures, knowledge of ETEC-associated illness, and by passing a written examination (70% passing score).
- •Availability for the study duration, including all planned follow-up visits.
排除标准
- •Presence of a significant medical or psychiatric condition which in the opinion of the investigator precludes participation in the study. Some medical conditions which are adequately treated and stable would not preclude entry into the study. These conditions might include stable asthma controlled with inhalers or mild hypertension stably controlled with a single agent.
- •Significant abnormalities in screening hematology, or serum chemistry as determined by PI or PI in consultation with the research monitor and sponsor.
- •Presence in the serum of HIV antibody, HBsAg, or HCV antibody.
- •Evidence of IgA deficiency (serum IgA < 7 mg/dL or below the limit of detection of assay).
- •Evidence of current excessive alcohol consumption or drug dependence (a targeted drug screen may be used to evaluate at the clinician's discretion).
- •Evidence of impaired immune function.
- •Recent vaccination or receipt of an investigational product (within 30 days before vaccination).
- •Any other criteria which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the safety of the study, or the results of the study
- •Research Related Exclusions Applicable to Vaccination and Challenge Participation
- •History of microbiologically confirmed ETEC or cholera infection in last 3 years.
- •Occupation involving handling of ETEC or Vibrio cholerae currently, or in the past 3 years.
- •Symptoms consistent with Travelers' Diarrhea concurrent with travel to countries where ETEC infection is endemic (most of the developing world) within 3 years prior to dosing, OR planned travel to endemic countries during the length of the study.
- •Vaccination for or ingestion of ETEC, cholera, or E coli heat labile toxin within 3 years prior to dosing.
- •Research Related Exclusions Not Applicable to Challenge-Only Participants
- •Exclusionary skin history/findings that would confound assessment or prevent appropriate local monitoring of AEs, or possibly increase the risk of an AE.
- •History of chronic skin disease (clinician judgment).- History of atopy such as active eczema.
- •Acute skin infection/eruptions on the upper arms including fungal infections, severe acne, or active contact dermatitis.
- •History of significant allergic reactions to any vaccines and allergies that may increase the risk of AEs (Well-controlled seasonal allergies responsive to antihistamine medication or intranasal steroids are not exclusionary per clinician determination).
- •Study-specific Exclusion Criteria
- •Abnormal stool pattern (fewer than 3 per week or more than 3 per day).
- •Regular use of laxatives, antacids, or other agents to lower stomach acidity.
- •Use of any medication known to affect the immune function (eg, systemic corticosteroids and others) within 30 days preceding the first vaccination or planned use during the active study period.
- •Known allergy to two of the following antibiotics: ciprofloxacin, trimethoprim-sulfamethoxazole, and penicillin.
结局指标
主要结局
Number of prevented diarrhea episodes
时间窗: 24 hours
Number of adverse events associated with vaccine
时间窗: Up to 1 year
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
Phase 1 Study of dmLT ID Vaccination in Healthy AdultsGastroenteritis Escherichia ColiNCT02531685National Institute of Allergy and Infectious Diseases (NIAID)100
已完成
1 期
Phase I Study of ETEC VaccineGastroenteritis Escherichia ColiNCT01147445National Institute of Allergy and Infectious Diseases (NIAID)36
Unknown
2 期
A Study of the ACYW135 Meningococcal Polysaccharide Conjugate VaccineMeningococcal MeningitisNCT06337071Aimei Vacin BioPharm (Zhejiang) Co., Ltd.1,200
已完成
1 期
Safety Study of Chimeric Vaccine to Prevent ETEC DiarrheaEscherichia Coli InfectionNCT01644565U.S. Army Medical Research and Development Command57
进行中（未招募）
2 期
Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric CancerGastric CancerNCT05771584Aston Sci. Inc.24