Clinical trial NCT01923779: 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: Grass Allergy
Rhinoconjunctivitis
Keywords: Grass allergy
Rhinoconjunctivitis
Environmental Exposure Unit
Immunotherapy
ToleroMune Grass
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
name: Pharm-Olam International
First posted: 2013-08-16
Enrollment: 163
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Rhinoconjunctivitis Symptom Score
timeFrame: Eighteen months post first dose in TG002
Secondary outcomes:
measure: Symptom scores for nasal and non nasal symptoms
timeFrame: Eighteen months post first dose in TG002
measure: Skin prick wheal diameter
timeFrame: Eighteen months post first dose in TG002
measure: Peak Nasal Inspiratory Flow
timeFrame: Eighteen months post first dose in TG002
measure: Grass specific IgA
timeFrame: Eighteen months post first dose in TG002
measure: Grass specific IgE
timeFrame: Eighteen months post first dose in TG002
measure: Grass specific IgG4
timeFrame: Eighteen months post first dose in TG002
measure: Adverse Events
timeFrame: Eighteen months post first dose in TG002
Other outcomes:
Locations:
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.