None listed
Conditions
Interventions
Intervention1: Heat-Labile Enterotoxin Of Escherichia Coli: 37.5&
g LT, two vaccinations (skin preparation and patch application) performed 14 days apart. Vaccinations will be administered by a clinician to alternating deltoids. Patches will be worn for six hours pr
Sponsors
Intercell USA, Inc. (Intercell)
20 Firstfield Road
Gaithersburg, Maryland 20878
United States of America (USA)
Eligibility
Inclusion criteria
Inclusion criteria: "A subject may be included in the study if he/she meets all of the following inclusion criteria: 1) 18-64 years of age at date of first vaccination; 2) Good health as determined by medical history and physical inspection; 3) Females of child-bearing potential must have a negative pregnancy test prior to first and second vaccination in the Country of Origin; females of child-bearing potential must agree not to become pregnant throughout the duration of study; 4) Subjects must have planned travel to DC, within 3 hours traveling distance of approved study site(s), for a minimum duration of stay of 7 days (no maximum stay is specified for inclusion). 5) Subject must be able to communicate in English"
Exclusion criteria
Exclusion criteria: A subject meeting any of the following criteria during the screening period is not eligible for participation in the study. Procedures for subject follow-up if an exclusion criterion is met post randomization 1) Abnormalities as determined by the Investigator/clinician during physical inspection; 2) Participated in research involving investigational product within 30 days before planned date of first vaccination; 3) Ever received LT, ETEC, or cholera vaccine; 4) History of diarrhea while traveling in a developing country within the last year (are provided in the study protocol); 5) Women who are pregnant or breastfeeding; 6) Clinically significant underlying enteric, pulmonary, cardiac, liver or renal disease; 7) History of Irritable Bowel Syndrome; 8) Seizure disorder within the last year; 9) Current use of immunosuppressive therapy (excluding inhaled steroids) or current immunodeficiency; 10) Known or suspected alcohol abuse or illicit drug use within the last year; 11) Medical history of HIV, HBV, or HCV; 12) An employee of a study site; 13) Known allergies to any component of the vaccine, including adhesives; 14) Planned use of antibiotics with known activity against gram negative facultative anaerobes; 15) Planned use of antacids, antidiarrheals, loperamide, bismuth subsalicylate, diphenoxylate or similar during the surveillance phase of the study; 16) An employee of Intercell (global) or an immediate family member."
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of cases of moderate/severe diarrheal cases during the surveillance period in which LT, LT/ST or ST toxins (ETEC) are detected.Timepoint: 9 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence, total stool frequency, and total duration of diarrheal episodes experienced during the surveillance period.Timepoint: 9 Months | — |
Countries
India
Contacts
Public Contactvivek malhotra
Outcome results
None listed