Clinical Safety and Tolerability Study of gpASIT+TM and gpASIT+TM/Immunoregulating Adjuvant to Treat Seasonal Grass Pollen Rhinoconjunctivitis

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and tolerability of gpASIT+TM administered subcutaneously in absence or in presence of an immunoregulating adjuvant in grass pollen allergic patients.

Official Title
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Clinical Safety and Tolerability of gpASIT+TM Administered Subcutaneously in Absence or in Presence of DnaK Immunoregulating Adjuvant for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis

Conditions
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Seasonal Allergic Rhinoconjunctivitis

Intervention / Treatment
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* Biological: gpASIT+TM
* Biological: gpAST+TM/adjuvant
* Biological: Placebo solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has given written informed consent Age between 18 and 50 years The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status Male or non pregnant, non-lactating female Females unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period)) Allergy diagnosis: A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least during the two previous years A positive skin prick test (wheal diameter ≥ 3 mm) to grass-pollen mixture Specific IgE against grass pollen (RAST class 2 or IgE > 0.7 kU/l) Asymptomatic to perennial inhalant allergens even if shown to be hypersensitive in a skin prick test. Exclusion Criteria: Subjects with current or past immunotherapy (any time in the past) A history of hypersensitivity to the excipients Subjects requiring control medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids) Subjects with documented evidence of acute or significant chronic sinusitis (as determined by investigator) Subjects with a history of hepatic or renal disease Subjects symptomatic to perennial inhalant allergens Subjects with rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…) Subject with malignant disease, autoimmune disease (and family medical history of autoimmune disease) Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric or duodenal ulcer, uncontrolled diabetes mellitus, etc…) Subjects requiring beta-blockers medication Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants) Subject with febrile illness (> 37.5°C, oral) A known positive serology for HIV-1/2, HBs antigen or anti-HCV antibodies The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry Receipt of blood or a blood derivative in the past 6 months preceding trial entry Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial Use of long-acting antihistamines Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD) Any condition which could be incompatible with protocol understanding and compliance Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator Participation in another clinical trial and/or treatment with an experimental drug within 1 month of trial start Subjects who participated to trial BTT-gpASIT003 and were in the treated groups

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Biological: Placebo solution<br>* 1 subcutaneous injection every 7 days, during 29 days<br>|
| Experimental: gpASIT+TM<br> | Biological: gpASIT+TM<br>* 1 subcutaneous injection every 7 days, during 29 days.<br>|
| Experimental: gpASIT+TM/adjuvant<br> | Biological: gpAST+TM/adjuvant<br>* 1 subcutaneous injection every 7 days, during 29 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical tolerability and safety of the treatment | The following parameters will be assessed : general physical status, vital signs, haematological parameters , general blood biochemistry parameters, all (serious) adverse, immunological analysis (total IgG, total IgE) and inflammatory parameters (CRP, sedimentation rate) | 3 times during the treatment phase, at week 24 (the end of the study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of gpASIT+TM on the immunological status of the subjects | The following parameters will be assessed : allergen-specific IgE, IgG, IgG4, IgA antibody concentrations, adjuvant-specific IgG antibody concentrations, lymphoproliferation and production of IL-10 in allergen and adjuvant stimulated PBMC. | visit 1, week 7, week 18 and week 24 | 
| Impact of gpASIT+TM on the clinical status of the subjects | The following parameters will be assessed (during the pollen season following treatment): daily average allergic symptom score, daily average allergic medication score, number of well-days, Visual Analogue Scale . | 1 May - 15 August 2010 |