Study to Assess the Immune Response to C13013
Research type
Research Study
Full title
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
IRAS ID
80977
Sponsor organisation
Millennium Pharmaceuticals Inc
Eudract number
2011-001874-24
Research summary
This study will look at the effects of vedolizumab on the body's ability to develop immunity to a hepatitis B vaccine and a cholera vaccine's well as the types of defenses the body creates. This study will also look to answer the following questions:1.What are the actions or effects of vedolizumab on the body? This process is called pharmacodynamic analysis.2.How is vedolizumab taken up (absorbed), broken down (metabolized), and eliminated (excreted) by the body? This process is called pharmacokinetic analysis.3.What side effects does a single dose of vedolizumab have in healthy individuals?
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
11/IE/0092
Date of REC Opinion
8 Aug 2011
REC opinion
Further Information Favourable Opinion