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

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.

Timeline

Start

2011-09

Primary completion

2012-05

Completion

2012-07

Publications

• Wyant T, Leach T, Sankoh S, Wang Y, Paolino J, Pasetti MF, Feagan BG, Parikh A. Vedolizumab affects antibody responses to immunisation selectively in the gastrointestinal tract: randomised controlled trial results. Gut. 2015 Jan;64(1):77-83. doi: 10.1136/gutjnl-2014-307127. Epub 2014 Apr 24.

Drugs

Indications