This is a multicenter, double-blind, randomized, placebo-controlled field trial to evaluate the epidemiology of natural infection with ETEC occurring after transcutaneous immunization in a field setting.
The primary objectives of the study are to evaluate the incidence of ETEC illness in a field setting and to compare the safety of LT delivered by TCI with placebo. The secondary objectives include, but are not limited to: evaluate the stool frequency per episode of ETEC illness in placebo recipients, to evaluate the immunogenicity of LT delivered by TCI, to evaluate the incidence of IBS following travel to areas of ETEC endemnicity, and to evaluate the incidence of VPO in placebo and LT patch recipients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
201
Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart.
The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.
West Coast Clinical Trials
Long Beach, California, United States
Radiant Research
Chicago, Illinois, United States
Incidence of Enterotoxigenic Escherichia coli (ETEC) illness defined as a diarrheal episode associated with an LT, LT/ST, or ST-positive ETEC strain isolated from a sample of a stool
Time frame: during the diarrheal episode or within 48 hours after the last stool in the diarrheal episode.
Safety of heat-labile enterotoxin of Escherichia coli (LT) delivered by transcutaneous immunization (TCI) vs placebo
Time frame: From vaccination 1 to completion of Day 180 follow-up, about a seven month time period
Stool frequency per episode of ETEC illness in placebo recipients
Time frame: Duration of stay in Mexico or Guatemala assessed up to four weeks
Immunogenicity of LT delivered by TCI
Time frame: at least three weeks prior to arrival in country, arrival in Mexico or Guatemala, and 5 to 18 days after arrival
Incidence of irritable bowel syndrome following travel to areas of ETEC endemnicity.
Time frame: Baseline through six months post return from Latin America. A period of about six months.
Incidence of vaccine preventable outcome in placebo and LT patch recipients.
Time frame: Duration of each individual participant stay in Mexico or Guatemala ranging from 7 to 28 Days.
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Johns Hopkins University, Bloomberg School of Public Health
Baltimore, Maryland, United States
Twin Cities Clinical Research
Minneapolis, Minnesota, United States
Advanced Biomedical Research
Hackensack, New Jersey, United States
Asthma Allergy & Associates
Ithica, New York, United States
Radiant Research
Columbus, Ohio, United States
Radiant Research
Dallas, Texas, United States
Breco Research
Houston, Texas, United States
Center for Infectious Diseases, The University of Texas Health Science Center at Houston
Houston, Texas, United States
...and 9 more locations