Healthy Volunteer Clinical Trial
Official title:
Human Challenge Model Refinement for B7A, An Enterotoxigenic Escherichia Coli (ETEC) Challenge Strain That Expresses CS6
The purpose of this study is to determine the safe and optimal dose and regimen (fasting
duration) for administering the challenge ETEC strain B7A, a CS6 expressing ETEC strain.
Additionally, an assessment of homologous protection following rechallenge with B7A will be
assessed.
Enterotoxigenic Escherichia coli (ETEC) is the most common causes of infectious diarrhea in
children in resource limited countries, and is also a frequent cause of traveler's diarrhea
in civilian and military travelers to endemic countries. ETEC strains express one or both of
two enterotoxins (heat labile toxin (LT) and heat stable toxin (ST)) that cause help the
bacteria cause the main symptom of watery diarrhea. They also express a variety of
colonization factors (CF) that help them attach to the intestinal wall. Each colonization
factor has one or more surface antigens (CS).
Vaccines and treatments to prevent ETEC disease are under development. Some of these target
specific enterotoxins or colonization factors. For over 40 years, we have used ETEC human
challenge studies to understand the ETEC disease process, immune response, and more recently,
to determine whether treatments or vaccines are protective or effective in mitigating
disease. One concern about these challenge study is the use of high doses of bacteria given
may overwhelm the protective efficacy of the vaccine or treatment. Several strains of ETEC
have been used in these challenge studies; a frequently used strain is B7A (CS6+, LT+, ST+.
O148:H28).
This study will explore the optimal dosing strategy for B7A, in order to minimize the dose of
ETEC necessary to produce disease in healthy adult volunteers. There will be two inpatient
admissions. The first will examine 4 dosing and fasting regimens in healthy volunteers. The
second admission will include volunteers who became ill during the first admission, as well
as a new group of volunteers. This second admission will validate the optimal dose from the
first admission, as well as to determine if previous infection with B7A ETEC will protect
against a new infection. Trying to understand the immune response to this challenge organism
may help us optimize vaccine design and delivery to protect people from this infection.
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