An Optional Follow-Up Study to Evaluate the Continued Efficacy of ToleroMune Grass in Grass Allergic Subjects Following Challenge With Grass Allergen in an Environmental Exposure Unit
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Circassia Limited
- Enrollment
- 163
- Primary Endpoint
- Total Rhinoconjunctivitis Symptom Score
Study Overview
Brief Summary
Grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy.
The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed all dosing visits in study TG002 approximately one year after the start of treatment.
Detailed Description
Subjects who completed all dosing visits and the post treatment challenge (PTC) in study TG002 will be invited to attend the Screening Visit for TG002a. Subjects will attend for 4 visits to the EEU on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Previously randomised into study TG002, completed all treatment visits and PTC during calendar year 2012.
Exclusion Criteria
- •"Partly controlled" and "uncontrolled" asthma
- •History of anaphylaxis to grass allergen
- •FEV1 <80% of predicted.
- •Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquilizers or psychoactive drugs
- •Symptoms of a clinically relevant illness
- •Subjects who cannot tolerate allergen challenge in the EEC
Outcomes
Primary Outcomes
Total Rhinoconjunctivitis Symptom Score
Time Frame: Eighteen months post first dose in TG002
Secondary Outcomes
- Grass specific IgE(Eighteen months post first dose in TG002)
- Skin prick wheal diameter(Eighteen months post first dose in TG002)
- Symptom scores for nasal and non nasal symptoms(Eighteen months post first dose in TG002)
- Peak Nasal Inspiratory Flow(Eighteen months post first dose in TG002)
- Grass specific IgA(Eighteen months post first dose in TG002)
- Grass specific IgG4(Eighteen months post first dose in TG002)
- Adverse Events(Eighteen months post first dose in TG002)