ISRCTN27362371已完成1 期
Phase I open label study to evaluate the safety and immunogenicity of heat-labile toxin (LT) vaccination by transcutaneous immunisation (TCI) in the elderly and compare elderly immune responses with those developed by healthy adults
Iomai Corporation (USA)0 个研究点目标入组 40 人开始时间: 2008年5月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy elderly (greater than or equal to 65 years of age) or adult (18 - 40 years of age) males and females
- •2. Signed informed consent
- •3. 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 the informed consent process) to not become pregnant through the end of the study. Also, they 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 intra-uterine device (IUD)
排除标准
- •1. Laboratory abnormalities (as determined by the toxicity grading scale [grade 1 - 4]) at laboratory screening
- •2. Abnormalities at physical examination (as determined by the toxicity grading scale [grade 1 - 4])
- •3. Known allergies to any component of the vaccine
- •4. Known disturbance of coagulation
- •5. Known allergies to adhesives
- •6. Participated in unrelated research involving investigational product within 90 days before planned date of first vaccination
- •7. Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd
- •8. Ever received cholera toxin or vaccine (e.g. Orochol®, Dukoral®)
- •9. Medical history of acute or chronic skin disease at vaccination site(s)
- •10. Active skin allergy
- •11. Recent or regular use of oral or injected steroid medications within 30 days prior to first vaccination
- •12. Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to first vaccination
- •13. Comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, end-stage renal disease, as determined by the investigator
- •14. Positive serology for human immunodeficiency virus-1 (HIV-1), human immunodeficiency virus-2 (HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
- •15. History of severe atopy
- •16. Signs or history of acute skin infection, sunburn or skin abnormalities at the vaccination area(s) including fungal infections, severe acne, history of keloid formation, or active contact dermatitis
- •17. Artificial tanning (ultraviolet [UV] radiation) or use of artificial/spray tan products over the duration of the study including the screening period
- •18. Hirsute (significant amount of hair) at vaccination area(s)
- •19. Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatological monitoring of the vaccination site(s)
- •20. Fever equal to or greater than 38.0°C (greater than or equal to 100.4°F) at the time of planned vaccination
- •21. Suspicion of or recent history of alcohol or substance abuse within one year of planned vaccination
- •22. Donated blood or blood products such as plasma within the past 90 days
- •23. Women who are pregnant or breastfeeding
- •24. Employee of the investigational site
- •25. Medical history of achlohydria
- •26. History of abdominal surgery (excluding caesarean 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 problems
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