Conditions: Inflammatory Bowel Disease
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 127
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Vedolizumab 750 mg, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18. arm 2: Vedolizumab placebo-matching, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.

Interventions: intervention 1: Vedolizumab intervention 2: Placebo intervention 3: Hepatitis B vaccine intervention 4: Oral cholera vaccine
Intervention descriptions: intervention 1: Vedolizumab for intravenous infusion intervention 2: Placebo intravenous infusion intervention 3: None intervention 4: None

Protocol document: