Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Adiga Life Sciences, Inc. | INDUSTRY |
| Pharm-Olam International | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TG002 Subjects | Subjects previously randomised in study TG002 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Total Rhinoconjunctivitis Symptom Score | Eighteen months post first dose in TG002 |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom scores for nasal and non nasal symptoms | Eighteen months post first dose in TG002 | |
| Skin prick wheal diameter | Eighteen months post first dose in TG002 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Subject previously randomised in study TG002 and completed all dosing visits and the PTC
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Peak Nasal Inspiratory Flow |
| Eighteen months post first dose in TG002 |
| Grass specific IgA | Eighteen months post first dose in TG002 |
| Grass specific IgE | 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 |