NCT01067781已完成2 期
A Phase 2, Gender-Stratified, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Two Vaccination Regimen With the Travelers' Diarrhea Vaccine System in Healthy Adults
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 10
- 主要终点
- Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs
研究概览
简要总结
The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing
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
- Triple (Participant, 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
- •A female or male 18-64 (inclusive) years of age;
- •In good health as determined by medical history and screening exam;
- •Females who are post-menopausal, surgically sterile, or have a negative serum/urine pregnancy test at Day 0 and agree not to become pregnant for the duration of study.
排除标准
- •Abnormalities at physical exam [as determined by the Toxicity Grading Scale (Grade 1-4)];
- •Laboratory abnormalities [as determined by the Toxicity Grading Scale (Grade 1 4)] at screening;
- •Participated in 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;
- •Women who are pregnant or breastfeeding;
- •Clinically significant underlying enteric, pulmonary, cardiac or renal disease;
- •Current seizure disorder;
- •Current use of immunosuppressive therapy (inhaled steroids are allowed);
- •Known or suspected alcohol abuse or illicit drug use within the last year;
- •Positive Serology for HIV-1, HIV-2, HbsAg, or HCV;
- •Known allergies to any component of the vaccine including adhesives;
- •An employee of the study site;
- •An employee of Intercell (global) or an immediate family member;
- •Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites;
- •Receipt of any routine vaccinations within 7 days prior to, or following, the date of planned study vaccinations.
结局指标
主要结局
Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs
时间窗: Day 0 to Day 180
Erythema, rash, pain, pruritus, hyperpigmentation, hypopigmentation and edema were solicited local AEs for the duration of the study. Fever, malaise, headache, and diarrhea were solicited systemic AEs for the first seven days following each vaccination; events reported outside this time frame were considered non-solicited.
次要结局
- Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers(Day 0 to Day 180)
- Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios(Day 0 to Day 180)
- Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates(Day 0 to Day 180)
研究者
研究点 (10)
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