ToleroMune Grass Follow on Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01923779

Enrollment

163

Registered

2013-08-16

Start date

2013-05-31

Completion date

2013-09-30

Last updated

2013-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Grass Allergy, Rhinoconjunctivitis

Keywords

Grass allergy, Rhinoconjunctivitis, Environmental Exposure Unit, Immunotherapy, ToleroMune Grass

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Total Rhinoconjunctivitis Symptom Score	Eighteen months post first dose in TG002

Secondary

Measure	Time frame
Skin prick wheal diameter	Eighteen months post first dose in TG002
Peak Nasal Inspiratory Flow	Eighteen months post first dose in TG002
Grass specific IgA	Eighteen months post first dose in TG002
Symptom scores for nasal and non nasal symptoms	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
Grass specific IgE	Eighteen months post first dose in TG002

Outcome results