NCT00751777已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Two Vaccination Regimen With an LT Vaccine Patch in Healthy Adults
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
研究概览
简要总结
To evaluate and compare the immune responses and safety following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or placebo patches.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males or females, 18-64 years of age (inclusive) at the planned start of the study (first vaccination on Day 0)
- •Signed Informed Consent
- •Women who are not post-menopausal or surgically sterile must have a negative serum/urine pregnancy test at screening and within 24 hours of each vaccination with understanding (through Informed Consent process) to not become pregnant and 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 or diaphragm, with spermicide), and IUD.
排除标准
- •Laboratory abnormalities [as determined by the Toxicity Grading Scale (grade 1 4)] at laboratory screening
- •Abnormalities at physical examination [as determined by the Toxicity Grading Scale (grade 1-4)]
- •Known allergies to any component of the vaccine
- •Known allergies to adhesives
- •Participated in research involving investigational product within 30 days before planned date of first vaccination or within 90 days after first vaccination
- •Donated blood or blood products such as plasma within 30 days prior to planned date of first vaccination or within 90 days after 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™)
- •History of diarrhea while traveling in a developing country within the last year
- •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
- •Positive serology for HIV-1, HIV-2, HBsAg, or HCV
- •Medical history of acute or chronic skin disease at vaccination area(s)
- •Active skin allergy
- •Signs of acute skin infection, sunburn or skin abnormalities at the vaccination area(s) including fungal infections, severe acne, or active contact dermatitis, or a history of keloid formation
- •Excessively hirsute and unwilling to clip hair at the vaccination area(s)
- •Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatologic monitoring of the vaccination site(s)
- •Fever greater than or equal to 38.0°C (100.4°F) at the time of planned vaccination
- •Women who are pregnant or breastfeeding
- •Acute illness at screening and unresolved at time of planned vaccination
- •Employee of the investigational site
结局指标
主要结局
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
时间窗: Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
时间窗: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194
GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data.
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
时间窗: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194
Definition of SCR: * Seroconversion IgG: ≥ 2-fold rise of LT IgG titer relative to baseline * Seroconversion IgA: ≥ 4-fold rise of LT IgA titer relative to baseline
次要结局
- Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch(13 months)
- Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear(1 month)
- Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group(13 months)
- Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group(13 months)
研究者
研究点 (6)
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