Coeliac DiseasePhase 1NCT00879749
Safety Study of Nexvax2 in Subjects With Coeliac Disease
A Phase 1 study testing 9 micrograms Nexvax2, 30 micrograms Nexvax2 and 90 micrograms Nexvax2 in people with Coeliac Disease and Celiac Disease, run by Nexpep Pty Ltd at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Coeliac Disease, Celiac Disease
- What is being tested?
- 9 micrograms Nexvax2, 30 micrograms Nexvax2 and 90 micrograms Nexvax2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesAustralia
- Study dates
- Apr 2009to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 18Show fewer
- 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.
- History of any medically significant condition considered by the Investigator to adversely affect participation in the trial.
- Non-compliance with a gluten free diet or flare in coeliac disease symptoms from Screening to Baseline.
- Clinically relevant abnormality on ECGs.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Q-Pharm Pty Ltd
Herston, Queensland, 4006
Nucleus Network - Centre for Clinical Studies
Melbourne, Victoria, 3004
About this study
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
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
- Coeliac Disease, Celiac Disease
- Being tested
- 9 micrograms Nexvax2, 30 micrograms Nexvax2, 90 micrograms Nexvax2, 60 micrograms Nexvax2, Up to 900 micrograms Nexvax2
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9 micrograms Nexvax2Biological
9 micrograms, weekly intra-dermal injection, 3 week duration
30 micrograms Nexvax2Biological
30 micrograms, weekly intra-dermal injection, 3 week duration
90 micrograms Nexvax2Biological
90 micrograms, weekly intra-dermal injection, 3 week duration
60 micrograms Nexvax2Biological
60 micrograms, weekly intra-dermal injection, 3 week duration
Up to 900 micrograms Nexvax2Biological
Up to 900 micrograms, weekly intra-dermal injection, 3 week duration
PlaceboOther
100 microlitres 0.9% sterile sodium chloride for injection
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Not described Receives: Other: Placebo |
| Nexvax2 | Experimental | Not described Receives: Biological: 9 micrograms Nexvax2; Biological: 30 micrograms Nexvax2; Biological: 90 micrograms Nexvax2; Biological: 60 micrograms Nexvax2; Biological: Up to 900 micrograms Nexvax2 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coeliac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nexpep Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gregor Brown, MBBS PhD FRACP, Principal investigator, The Alfred Hospital, VictoriaJames Daveson, MBBS FRACP, Principal investigator, Princess Alexandra Hospital, Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879749
- Sponsor's protocol ID
- Nexvax2-001
- Status last verified
- Apr 2011
- First submitted
- 8 Apr 2009
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20650871
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00879749
- Acronym / sponsor ID
- Nexvax2-001
- Conditions
- Coeliac Disease, Celiac Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Nexpep Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Other: Placebo |
| Nexvax2 | Experimental | Biological: 9 micrograms Nexvax2, Biological: 30 micrograms Nexvax2, Biological: 90 micrograms Nexvax2, Biological: 60 micrograms Nexvax2, Biological: Up to 900 micrograms Nexvax2 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18 to 60 years (inclusive)
- Have coeliac disease meeting the following criteria:
- 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 (18 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 9 micrograms Nexvax29 micrograms, weekly intra-dermal injection, 3 week duration | Biological | Nexvax2 |
| 30 micrograms Nexvax230 micrograms, weekly intra-dermal injection, 3 week duration | Biological | Nexvax2 |
| 90 micrograms Nexvax290 micrograms, weekly intra-dermal injection, 3 week duration | Biological | Nexvax2 |
| 60 micrograms Nexvax260 micrograms, weekly intra-dermal injection, 3 week duration | Biological | Nexvax2 |
| Up to 900 micrograms Nexvax2Up to 900 micrograms, weekly intra-dermal injection, 3 week duration | Biological | Nexvax2 |
| Placebo100 microlitres 0.9% sterile sodium chloride for injection | Other | Saline |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
- Derived from this study: PubMed 20650871Tye-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.
- Nexpep Pty LtdLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregor Brown, MBBS PhD FRACP principal investigator
The Alfred Hospital, Victoria
James Daveson, MBBS FRACP principal investigator
Princess Alexandra Hospital, Queensland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 9 micrograms Nexvax2, 30 micrograms Nexvax2 and 90 micrograms Nexvax2 in people with Coeliac Disease and Celiac Disease, run by Nexpep Pty Ltd at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00879749, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2011.