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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Safety Study of Nexvax2 in Subjects With Coeliac Disease
Scientific 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
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coeliac Disease 0 0
Celiac Disease 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Study type
Description of intervention(s) / exposure
Other interventions - 9 micrograms Nexvax2
Other interventions - 30 micrograms Nexvax2
Other interventions - 90 micrograms Nexvax2
Other interventions - 60 micrograms Nexvax2
Other interventions - Up to 900 micrograms Nexvax2
Other interventions - Placebo

Placebo Comparator: Saline -

Experimental: Nexvax2 -

Other interventions: 9 micrograms Nexvax2
9 micrograms, weekly intra-dermal injection, 3 week duration

Other interventions: 30 micrograms Nexvax2
30 micrograms, weekly intra-dermal injection, 3 week duration

Other interventions: 90 micrograms Nexvax2
90 micrograms, weekly intra-dermal injection, 3 week duration

Other interventions: 60 micrograms Nexvax2
60 micrograms, weekly intra-dermal injection, 3 week duration

Other interventions: Up to 900 micrograms Nexvax2
Up to 900 micrograms, weekly intra-dermal injection, 3 week duration

Other interventions: Placebo
100 microlitres 0.9% sterile sodium chloride for injection

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group


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

- 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

- 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.

Minimum age
18 Years
Maximum age
60 Years
Both males and females
Can healthy volunteers participate?
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

- 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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd - Herston
Recruitment hospital [2] 0 0
Nucleus Network - Centre for Clinical Studies - Melbourne
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Nexpep Pty Ltd

Ethics approval
Ethics application status

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 website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Gregor Brown, MBBS PhD FRACP
Address 0 0
The Alfred Hospital, Victoria
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications