Safety Study of Grass Pollen-derived Peptides to Treat Seasonal Allergic Rhinoconjunctivitis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the oral administration of grass pollen peptides is safe and effective in the treatment of allergic rhinitis.

Official Title
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Preliminary Assessment of the Clinical Tolerability, Safety and Immunogenicity of Three Different Doses of Grass Pollen-derived Peptides for Oral Use in Antigen-specific Immunotherapy of Seasonal Allergic Rhinoconjunctivitis

Conditions
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Seasonal Allergic Rhinoconjunctivitis

Intervention / Treatment
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* Biological: gpASIT+TM
* Biological: Placebo
* Biological: gpASIT+TM
* Biological: gpASIT+TM


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 Female 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: A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least 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. Exclusion Criteria: Subjects with current or past immunotherapy (any time in the past) Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids) Documented evidence of acute or significant chronic sinusitis (as determined by individual investigator) Subjects with a history of hepatic or renal disease Subjects symptomatic to perennial inhalant allergens Subject with malignant disease, autoimmune disease Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD) 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 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 Participation in another clinical trial and/or treatment with an experimental drug within 1 month of trial start A history of hypersensitivity to the excipients Rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…) Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator Subjects who participated to trial BTT-gpASIT002

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<br>* placebo entero-coated capsules<br>|
| Experimental: gpASIT 25<br> | Biological: gpASIT+TM<br>* entero-coated capsules containing 25µg of gpASIT+TM<br>|
| Experimental: gpASIT 100<br> | Biological: gpASIT+TM<br>* entero-coated capsules containing 100µg of gpASIT+TM<br>|
| Experimental: gpASIT 400<br> | Biological: gpASIT+TM<br>* entero-coated capsules containing 400µg of gpASIT+TM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of allergic reaction |  | within the first 14 days (plus or minus 1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological assessment |  | 9 months | 
| Allergy symptom and medication scores |  | grass pollen season 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hay fever, grass pollen allergy