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

NCT01981616 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2014-07-21

Study results available
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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

Interventions

DRUG

Vedolizumab

Vedolizumab for intravenous infusion

DRUG

Placebo

Placebo intravenous infusion

BIOLOGICAL

Hepatitis B vaccine

BIOLOGICAL

Oral cholera vaccine

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-05-31
Completion
2012-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01981616 on ClinicalTrials.gov