At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 127 enrolled
Drug / intervention
Vedolizumab +3 moredrug
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.
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single Dose Study in Healthy Subjects to Determine the Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab
In Brief
A Phase 1 clinical trial evaluating Vedolizumab, Placebo, and 2 other interventions for Inflammatory Bowel Disease. Completed, enrolled 127 participants across 1 site.
Detailed Summary
The primary purpose of this study is to determine the rates of seroconversion to a hepatitis B vaccine series after a single 750 mg intravenous (IV) dose of vedolizumab or placebo. Secondary objectives are to determine the rates of seroconversion to an oral cholera vaccine series, assess change in anti-hepatitis B surface antibodies and assess the safety and tolerability of a single 750-mg IV dose of vedolizumab.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammatory Bowel Disease
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2011
Primary CompletionMay 2012
Study CompletionJul 2012
First PostedNov 2013
TodayJul 2026
First PostedNov 11, 2013
Enrollment StartSep 1, 2011
Primary CompletionMay 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.6 years ago
Interventions
Vedolizumabdrug
Vedolizumab for intravenous infusion
Placebodrug
Placebo intravenous infusion
Hepatitis B vaccinebiological
Oral cholera vaccinebiological