ToleroMune Grass Follow on Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Rhinoconjunctivitis Grass Allergy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TG002 Subjects

Subjects previously randomised in study TG002

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kanata, Ontario, Canada

Site Status

Kingston, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED

PMID: 31568796 (View on PubMed)

Other Identifiers

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TG002B

Identifier Type: -

Identifier Source: org_study_id