At a glance
ClinicalIndex Comparison RecordN/ACompleted· 47 enrolled
Drug / intervention
ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Bufferbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Human Challenge Model Refinement for B7A, An Enterotoxigenic Escherichia Coli (ETEC) Challenge Strain That Expresses CS6
Johns Hopkins Bloomberg School of Public Health·interventional·Posted May 16, 2016·Updated Jul 6, 2018
In Brief
A clinical study evaluating ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer for Healthy Volunteer. Completed, enrolled 47 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer
CountriesUnited States
CollaboratorsUnited States Department of Defense, PATH, Naval Medical Research Center
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartApr 2016
First PostedMay 2016
Primary CompletionDec 2016
TodayJul 2026
First PostedMay 16, 2016
Enrollment StartApr 1, 2016
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.1 years ago
Interventions
ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Bufferbiological
ETEC Bacteria