Travelers' Diarrhea MedDRA version: 13.1 Level: LLT Classification code 10044552 Term: Traveller's diarrhea System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: TD Vaccine System
Product Code: TD Vaccine System
Pharmaceutical Form: Transdermal patch
Current Sponsor code: Heat Labile Enterotoxin of Escherichia Coli
Other descriptive name: LT
C
Sponsors
Intercell USA, Inc. (Intercell)
Eligibility
Sex/Gender
All
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 childbearing potential must agree not to become pregnant throughout the duration of study 4. Subjects must have planned travel to an area within 3 hours traveling distance of Mexico City, Cuernavaca, Guadalajara, Oaxaca, or San Miguel de Allende, Mexico or Antigua, Quetzaltenango, Guatemala City, or Solola, Guatemala 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2083 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject meeting any of the following criteria during the screening period is not eligible for participation in the study: 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; 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 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 from two weeks prior to randomization through the surveillance phase of the study. 16. An employee of Intercell (global) or an immediate family member
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of the TD Vaccine System to prevent moderate to severe ETEC disease in a field setting. ;Secondary Objective: Secondary objectives of the study are to evaluate the efficacy of the TD Vaccine System to alleviate symptoms and characteristics associated with TD and to reduce the burden of gastrointestinal (GI) illness experienced, as well as to evaluate the safety and immunogenicity of the vaccine.;Primary end point(s): • The incidence of cases with vaccine preventable outcome (VPO) reported during the surveillance period; VPO is all moderate/severe diarrheal cases in which LT, LT/ST or ST toxins (ETEC) are detected by either PCR or DNA hybridization (and no co-pathogen is detected) from diarrheal stool samples that are collected during first diarrheal episode ;Timepoint(s) of evaluation of this end point: Surveillance Period - through Day 17 visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The incidence of moderate/severe all-cause diarrheal episodes (i.e., with or without ETEC diagnosis) [first diarrheal episode experienced during the surveillance period] 2. Total unformed stool frequency from all all-cause diarrheal episodes (mild, moderate or severe) experienced per subject during the surveillance period 3. Total duration of all all-cause diarrheal episodes (mild, moderate or severe) experienced per subject during the surveillance period ;Timepoint(s) of evaluation of this end point: Surveillance Period - through Day 17 visit | — |
Countries
Germany, Guatemala, Mexico, United Kingdom
Contacts
Public ContactRobert Dallimore, Vice President
Intercell USA, Inc.
Outcome results
None listed