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| Name | Class |
|---|---|
| Adiga Life Sciences, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TG002 Subjects | Subjects previously randomised in study TG002 |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Rhinoconjunctivitis Symptom Scores | 32 months post first dose in TG002 |
| Measure | Description | Time Frame |
|---|---|---|
| Grass Specific Immunoglobulin A (IgA) | 32 months post first dose in TG002 | |
| Grass Specific Immunoglobulin E (IgE) | 32 months post first dose in TG002 | |
| Grass Specific Immunoglobulin G Isotype 4 (IgG4) |
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Inclusion Criteria:
Exclusion Criteria:
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Subject previously randomised in study TG002 and completed all dosing visits and the PTC
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanata | Ontario | Canada | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31568796 | Derived | 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. |
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| 32 months post first dose in TG002 |
| Skin Prick Weal Diameter | 32 months post first dose in TG002 |
| Adverse Events | 32 months post first dose in TG002 |
| Kingston |
| Ontario |
| Canada |