NCT00879749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

April 7, 2011

Status Verified

April 1, 2011

Enrollment Period

11 months

First QC Date

April 8, 2009

Last Update Submit

April 5, 2011

Conditions

Coeliac DiseaseCeliac Disease

Study Arms (2)

Saline

PLACEBO COMPARATOR
Other: Placebo

Nexvax2

EXPERIMENTAL
Biological: 9 micrograms Nexvax2Biological: 30 micrograms Nexvax2Biological: 90 micrograms Nexvax2Biological: 60 micrograms Nexvax2Biological: Up to 900 micrograms Nexvax2

Interventions

9 micrograms Nexvax2BIOLOGICAL

9 micrograms, weekly intra-dermal injection, 3 week duration

Nexvax2
30 micrograms Nexvax2BIOLOGICAL

30 micrograms, weekly intra-dermal injection, 3 week duration

Nexvax2
90 micrograms Nexvax2BIOLOGICAL

90 micrograms, weekly intra-dermal injection, 3 week duration

Nexvax2
60 micrograms Nexvax2BIOLOGICAL

60 micrograms, weekly intra-dermal injection, 3 week duration

Nexvax2
Up to 900 micrograms Nexvax2BIOLOGICAL

Up to 900 micrograms, weekly intra-dermal injection, 3 week duration

Nexvax2
PlaceboOTHER

100 microlitres 0.9% sterile sodium chloride for injection

Saline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 60 years (inclusive)
  • 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.
  • Either male or non-lactating, non-pregnant females who are postmenopausal, sterile or using at least two acceptable and highly effective birth control methods.

You may not qualify if:

  • Subjects possess the genes encoding HLA DQ8 (either DQA1\*03 or DQB1\*0302).
  • Uncontrolled complications of coeliac disease which, in the opinion of the Investigator, would impact immune response or pose an increased risk to the subject.
  • Systemic biological agents less than 6 months prior to Day 1.
  • Receipt of systemic immunomodulatory agents or experimental drugs less than 30 days prior to Day 1.
  • 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.
  • Subjects who smoke or who have smoked at all in the past 3 months.
  • Positive pregnancy test at Screening or Baseline.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Q-Pharm Pty Ltd

Herston, Queensland, 4006, Australia

Location

Nucleus Network - Centre for Clinical Studies

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

  • 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.

    PMID: 20650871DERIVED

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Gregor Brown, MBBS PhD FRACP

    The Alfred Hospital, Victoria

    PRINCIPAL INVESTIGATOR

  • James Daveson, MBBS FRACP

    Princess Alexandra Hospital, Queensland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 8, 2009

First Posted

April 10, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2010

Study Completion

June 1, 2010

Last Updated

April 7, 2011

Record last verified: 2011-04

Locations

AU(2)