Safety Study of Nexvax2 in Subjects With Coeliac Disease

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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.
• 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.