Journal article
Epitope-specific immunotherapy targeting CD4-positive T cells in coeliac disease: two randomised, double-blind, placebo-controlled phase 1 studies
Gautam Goel, Tim King, A James Daveson, Jane M Andrews, Janakan Krishnarajah, Richard Krause, Gregor JE Brown, Ronald Fogel, Charles F Barish, Roger Epstein, Timothy P Kinney, Philip B Miner, Jason A Tye-Din, Adam Girardin, Juha Taavela, Alina Popp, John Sidney, Markku Maki, Kaela E Goldstein, Patrick H Griffin Show all
LANCET GASTROENTEROLOGY & HEPATOLOGY | ELSEVIER INC | Published : 2017
Abstract
BACKGROUND: A gluten-free diet is the only means to manage coeliac disease, a permanent immune intolerance to gluten. We developed a therapeutic vaccine, Nexvax2, designed to treat coeliac disease. Nexvax2 is an adjuvant-free mix of three peptides that include immunodominant epitopes for gluten-specific CD4-positive T cells. The vaccine is intended to engage and render gluten-specific CD4-positive T cells unresponsive to further antigenic stimulation. We assessed the safety and pharmacodynamics of the vaccine in patients with coeliac disease on a gluten-free diet. METHODS: We did two randomised, double-blind, placebo-controlled, phase 1 studies at 12 community sites in Australia, New Zealand..
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Funding Acknowledgements
ImmusanT.