NCT00672035已完成2 期
Randomized, Double-Blinded, Placebo-Controlled, Dose Ranging Study to Assess the Immunogenicity and Safety of LT Application in Healthy Adults
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 406
- 试验地点
- 10
- 主要终点
- To evaluate the immunogenicity of LT application at different doses
研究概览
简要总结
The main purpose of this study is to evaluate the body's immune response to the LT patch at different doses.
The secondary purpose of this study is to evaluate the safety of the LT patches at different doses and the safety of the skin preparation system. Another secondary purpose is to compare the safety and the body's immune response to LT patches placed on the upper arm versus the lower back.
详细描述
This is a randomized, double-blind, placebo-controlled, dose ranging, multicenter study. Subjects will be assigned to one of ten treatment groups and vaccinated according to the study group designation. Treatments will remain the same for first and second vaccinations (alternating left and right sides).
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males or females 18 to 40 years of age with signed informed consent.
- •Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours prior to each vaccination with understanding (through informed consent process) to not become pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study.
- •Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom, diaphragm with spermicide), and IUD.
- •Subjects meeting any of the following criteria are not eligible for participation in the study:
排除标准
- •Laboratory abnormalities.
- •Abnormalities at physical examination
- •Known allergies to any component of the vaccine.
- •Known disturbance of coagulation.
- •Known allergies to adhesives.
- •Participated in unrelated research involving investigational product within 30 days before planned date of first vaccination.
- •Ever received investigational enterotoxigenic E. coli, LT, or LT(R192G) or NasalFlu, Berna Biotech, Ltd.
- •Ever received cholera toxin or vaccine (e.g. Orochol™, Dukoral™).
- •Medical history of acute or chronic skin disease at vaccination site(s).
- •Active skin allergy.
- •Recent or regular use of oral or injected steroid medications.
- •Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to first vaccination.
- •Comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, end-stage renal disease, as determined by the Investigator.
- •Positive serology for HIV-1, HIV-2, HBsAg, or HCV.
- •History of severe atopy. Signs or history of acute skin infection, sunburn or skin abnormalities on the vaccination area(s) including fungal infections, severe acne, history of keloid formation, or active contact dermatitis.
- •Artificial tanning (UV radiation) over the duration of the study including the screening period.
- •Hirsute (significant amount of hair) at vaccination area(s).
- •Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatological monitoring of the vaccination site(s).
- •Fever equal to or greater than 38.0°C (≥100.4°F) at the time of planned vaccination.
- •Suspicion of or recent history of alcohol or substance abuse.
- •Donated blood or blood products such as plasma within the past 30 days.
- •Women who are pregnant or breastfeeding.
- •Employee of the investigational site.
- •Medical history of achlorhydria.
- •History of abdominal surgery (excluding C-section, hysterectomy, cosmetic surgery, liposuction, appendectomy, cholecystectomy, ventral hernia repair, and other surgeries not pertaining to gastrointestinal problems) or history of, or recent acute gastrointestinal illness.
结局指标
主要结局
To evaluate the immunogenicity of LT application at different doses
时间窗: 6 months
次要结局
- To evaluate the safety of LT application at different doses(6 months)
- To evaluate the safety of the skin preparation system(6 months)
- To compare patch performance (safety and immunogenicity) on different anatomical parts of the body(6 months)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
1 期
A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese WomenOsteopeniaNCT01101061Amgen31
已完成
1 期
A Study of V950 in People With Alzheimer Disease (V950-001 AM7)Alzheimer DiseaseNCT00464334Merck Sharp & Dohme LLC86
已完成
2 期
Study of the Safety, Pharmacodynamics, Efficacy, and PK of TIMP-GLIA in Subjects With Celiac DiseaseCeliac DiseaseNCT03738475Takeda34
已完成
2 期
A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older AdultsHealthyNCT04453202Janssen Vaccines & Prevention B.V.459
已完成
不适用
Safety and Immunogenicity Study of Fluval AB-Like Flu Vaccines With 3.5, 6, 9 or 15 μg HA in Adult and Elderly PeopleInfluenzaNCT01408290Fluart Innovative Vaccine Ltd, Hungary256