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Safety Study of Nexvax2 in Subjects With Coeliac Disease

NCT00879749 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2011-04-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Nexpep Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Gregor Brown, MBBS PhD FRACP · The Alfred Hospital, Victoria

  • James Daveson, MBBS FRACP · Princess Alexandra Hospital, Queensland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-03-31
Completion
2010-06-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00879749 on ClinicalTrials.gov