NCT01981616

Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammatory Bowel Disease

Interventions

Type	Name	Description
DRUG	Vedolizumab	Vedolizumab for intravenous infusion
DRUG	Placebo	Placebo intravenous infusion
BIOLOGICAL	Hepatitis B vaccine
BIOLOGICAL	Oral cholera vaccine

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2013-11-11
• Last updated: 2014-07-21
• Results posted: 2014-07-21

Locations

1 site across 1 country: United Kingdom