Safety Study of Nexvax2 in Subjects With Coeliac Disease
NCT ID: NCT00879749
Last Updated: 2011-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
2009-04-30
2010-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Saline
Placebo
100 microlitres 0.9% sterile sodium chloride for injection
Nexvax2
9 micrograms Nexvax2
9 micrograms, weekly intra-dermal injection, 3 week duration
30 micrograms Nexvax2
30 micrograms, weekly intra-dermal injection, 3 week duration
90 micrograms Nexvax2
90 micrograms, weekly intra-dermal injection, 3 week duration
60 micrograms Nexvax2
60 micrograms, weekly intra-dermal injection, 3 week duration
Up to 900 micrograms Nexvax2
Up to 900 micrograms, weekly intra-dermal injection, 3 week duration
Interventions
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9 micrograms Nexvax2
9 micrograms, weekly intra-dermal injection, 3 week duration
30 micrograms Nexvax2
30 micrograms, weekly intra-dermal injection, 3 week duration
90 micrograms Nexvax2
90 micrograms, weekly intra-dermal injection, 3 week duration
60 micrograms Nexvax2
60 micrograms, weekly intra-dermal injection, 3 week duration
Up to 900 micrograms Nexvax2
Up to 900 micrograms, weekly intra-dermal injection, 3 week duration
Placebo
100 microlitres 0.9% sterile sodium chloride for injection
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
60 Years
ALL
No
Sponsors
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Nexpep Pty Ltd
INDUSTRY
Responsible Party
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Nexpep Pty Ltd
Principal Investigators
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Gregor Brown, MBBS PhD FRACP
Role: PRINCIPAL_INVESTIGATOR
The Alfred Hospital, Victoria
James Daveson, MBBS FRACP
Role: PRINCIPAL_INVESTIGATOR
Princess Alexandra Hospital, Queensland
Locations
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Q-Pharm Pty Ltd
Herston, Queensland, Australia
Nucleus Network - Centre for Clinical Studies
Melbourne, Victoria, Australia
Countries
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References
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Tye-Din JA, Stewart JA, Dromey JA, Beissbarth T, van Heel DA, Tatham A, Henderson K, Mannering SI, Gianfrani C, Jewell DP, Hill AV, McCluskey J, Rossjohn J, Anderson RP. Comprehensive, quantitative mapping of T cell epitopes in gluten in celiac disease. Sci Transl Med. 2010 Jul 21;2(41):41ra51. doi: 10.1126/scitranslmed.3001012.
Other Identifiers
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Nexvax2-001
Identifier Type: -
Identifier Source: org_study_id
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