Traveler's Diarrhea (TD) Automated Process

Intercell

Status and phase

Completed

Phase 2

Conditions

Prevention of Travelers' Diarrhea

Treatments

Biological: Placebo

Biological: heat-labile enterotoxin of E. coli (LT)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00751777

ELT207

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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