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Safety Study of Nexvax2 in Subjects With Coeliac Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00879749
Recruitment Status : Completed
First Posted : April 10, 2009
Last Update Posted : April 7, 2011
Information provided by:
Nexpep Pty Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Coeliac Disease Celiac Disease Biological: 9 micrograms Nexvax2 Biological: 30 micrograms Nexvax2 Biological: 90 micrograms Nexvax2 Biological: 60 micrograms Nexvax2 Biological: Up to 900 micrograms Nexvax2 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Placebo Comparator: Saline Other: Placebo
100 microlitres 0.9% sterile sodium chloride for injection

Experimental: Nexvax2 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  1. Age 18 to 60 years (inclusive)
  2. Have coeliac disease meeting the following criteria:

    • the Principal Investigator is satisfied coeliac disease has been correctly diagnosed,
    • HLA DQ2 genotype (both HLA DQA1*05 and DQB1*02, homo- or hetero-zygous),
    • no known or suspected gluten exposure for 2 months prior to enrolment
    • were prescribed and have intended to follow a gluten-free diet for at least one year
    • antibodies to tissue transglutaminase (tTG) IgA and/or deamidated gliadin peptide (DGP) IgA and IgG within normal reference range at time of screening.
  3. Either male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods.

Key Exclusion Criteria:

  1. Subjects possess the genes encoding HLA DQ8 (either DQA1*03 or DQB1*0302).
  2. Uncontrolled complications of coeliac disease which, in the opinion of the Investigator, would impact immune response or pose an increased risk to the subject.
  3. Systemic biological agents less than 6 months prior to Day 1.
  4. Receipt of systemic immunomodulatory agents or experimental drugs less than 30 days prior to Day 1.
  5. Any of the following laboratory abnormalities at Screening:

    • ALT, AST or alkaline phosphatase (ALP) > 1.5 times the upper limit of normal (ULN)
    • Calculated creatinine clearance < 80 mL/min
    • Haemoglobin (Hb) outside of the normal range
    • Platelet count <125 x 109/L
    • Serum potassium outside of the normal range
    • White blood cell (WBC) count outside of the normal range
    • Thyroid stimulating hormone (TSH) outside of the normal range
    • Any other clinically significant abnormal lab values, as determined by the Clinical Investigator.
  6. Subjects who smoke or who have smoked at all in the past 3 months.
  7. Positive pregnancy test at Screening or Baseline.
  8. History of any medically significant condition considered by the Investigator to adversely affect participation in the trial.
  9. Non-compliance with a gluten free diet or flare in coeliac disease symptoms from Screening to Baseline.
  10. Clinically relevant abnormality on ECGs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879749

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Australia, Queensland
Q-Pharm Pty Ltd
Herston, Queensland, Australia, 4006
Australia, Victoria
Nucleus Network - Centre for Clinical Studies
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Nexpep Pty Ltd
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Principal Investigator: Gregor Brown, MBBS PhD FRACP The Alfred Hospital, Victoria
Principal Investigator: James Daveson, MBBS FRACP Princess Alexandra Hospital, Queensland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Robert Anderson/Chief Executive Officer, Nexpep Pty Ltd
ClinicalTrials.gov Identifier: NCT00879749    
Other Study ID Numbers: Nexvax2-001
First Posted: April 10, 2009    Key Record Dates
Last Update Posted: April 7, 2011
Last Verified: April 2011
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases