NCT00879749

Safety Study of Nexvax2 in Subjects With Coeliac Disease

A Phase I Study to Determine Safety, Tolerability and Bioactivity of Nexvax2 in HLA DQ2+ Volunteers With Coeliac Disease Following a Long-term, Strict Gluten-free Diet

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Nexpep Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to determine the safety of weekly injections of Nexvax2 given for three weeks to patients with coeliac disease who have been on a gluten-free diet. The second purpose of this study is to compare the immune response over the three week study period in coeliac disease patients given Nexvax2 compared to those given saline.

Conditions

• Coeliac Disease
• Celiac Disease

Interventions

Type	Name	Description
BIOLOGICAL	9 micrograms Nexvax2	9 micrograms, weekly intra-dermal injection, 3 week duration
BIOLOGICAL	30 micrograms Nexvax2	30 micrograms, weekly intra-dermal injection, 3 week duration
BIOLOGICAL	90 micrograms Nexvax2	90 micrograms, weekly intra-dermal injection, 3 week duration
BIOLOGICAL	60 micrograms Nexvax2	60 micrograms, weekly intra-dermal injection, 3 week duration
BIOLOGICAL	Up to 900 micrograms Nexvax2	Up to 900 micrograms, weekly intra-dermal injection, 3 week duration
OTHER	Placebo	100 microlitres 0.9% sterile sodium chloride for injection

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-03-01
• Completion: 2010-06-01
• First posted: 2009-04-10
• Last updated: 2011-04-07

Locations

2 sites across 1 country: Australia