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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
9 micrograms, weekly intra-dermal injection, 3 week duration
30 micrograms, weekly intra-dermal injection, 3 week duration
90 micrograms, weekly intra-dermal injection, 3 week duration
Q-Pharm Pty Ltd
Herston, Queensland, Australia
Nucleus Network - Centre for Clinical Studies
Melbourne, Victoria, Australia
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60 micrograms, weekly intra-dermal injection, 3 week duration
Up to 900 micrograms, weekly intra-dermal injection, 3 week duration
100 microlitres 0.9% sterile sodium chloride for injection