Immune Response to Systemic and Mucosal Antigenic Challenge in the Presence of Vedolizumab
- Conditions
- Inflammatory Bowel Disease
- Interventions
- Registration Number
- NCT01981616
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vedolizumab 750 mg Oral cholera vaccine 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. Vedolizumab 750 mg Hepatitis B vaccine 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. Placebo Placebo 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. Placebo Hepatitis B vaccine 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. Placebo Oral cholera vaccine 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. Vedolizumab 750 mg Vedolizumab 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With an Immune Response to Hepatitis B Vaccine at Day 74 Day 74 Immune response was defined as hepatitis B surface antibody (anti-HBs) ≥ 10 IU/L.
- Secondary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) From the first dose of study medication through Day 127 An AE was defined as any untoward medical occurrence in a subject administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment.
Serious adverse event (SAE) meant any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect or was a medically important event. Relationship of each AE to study drug was determined by the Investigator.Percentage of Participants With an Immune Response to Oral Cholera Vaccine Baseline and Day 74 A positive immune response was defined as an increase of greater than 4-fold over the Baseline immunoglobulin M (IgM), IgG, or IgA anticholera antibodies.
Anti-Hepatitis B Surface Antibody Over Time Baseline and Days 18, 32, 60 and 74
Trial Locations
- Locations (1)
ICON Development Solutions
🇬🇧Manchester, United Kingdom