Clinical trial NCT02292875: ToleroMune Grass Follow on Study
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinoconjunctivitis
Grass Allergy
Keywords: Grass Allergy
Rhinoconjunctivitis
Environmental Exposure Unit
Immunotherapy
ToleroMune Grass
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
First posted: 2014-11-17
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject previously randomised in study TG002 and completed all dosing visits and the PTC

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 two years after the start of treatment.

Detailed description: This is a follow-up study to a multi-centre, randomised, double-blind, placebo controlled, parallel group clinical study (TG002) which evaluated the efficacy, safety and tolerability of three doses of ToleroMune Grass versus placebo in grass allergic subjects. Subjects who completed TG002 in calendar year 2012 will undergo a further single exposure to grass allergens in an EEU.

Eligibility criteria: Inclusion Criteria:

* Previously randomised into study TG002, and completed all treatment visits and PTC during calendar year 2012

Exclusion Criteria:

* "Partly controlled" and "uncontrolled" asthama
* History of anaphylaxis to grass allergen
* FEV1 \<80% of predicted
* Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquilizers or psychoactuve drugs
* Symptoms of a clinically relevant illness
* Subjects who cannot tolerate allergen challenge in the EEU

Primary outcomes:
measure: Total Rhinoconjunctivitis Symptom Scores
timeFrame: 32 months post first dose in TG002
Secondary outcomes:
measure: Grass Specific Immunoglobulin A (IgA)
timeFrame: 32 months post first dose in TG002
measure: Grass Specific Immunoglobulin E (IgE)
timeFrame: 32 months post first dose in TG002
measure: Grass Specific Immunoglobulin G Isotype 4 (IgG4)
timeFrame: 32 months post first dose in TG002
measure: Skin Prick Weal Diameter
timeFrame: 32 months post first dose in TG002
measure: Adverse Events
timeFrame: 32 months post first dose in TG002
Other outcomes:
Locations:
city: Kanata
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
Study officials:
References:
citation: Ellis AK, Frankish CW, Armstrong K, Steacy L, Tenn MW, Pawsey S, Hafner RP. Persistence of the clinical effect of grass allergen peptide immunotherapy after the second and third grass pollen seasons. J Allergy Clin Immunol. 2020 Feb;145(2):610-618.e9. doi: 10.1016/j.jaci.2019.09.010. Epub 2019 Sep 27.