Seasonal Allergic Rhinoconjunctivitis
Conditions
Brief summary
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.
Interventions
BIOLOGICALgpASIT+TM
1 subcutaneous injection every 7 days, during 29 days.
BIOLOGICALgpAST+TM/adjuvant
1 subcutaneous injection every 7 days, during 29 days
BIOLOGICALPlacebo solution
1 subcutaneous injection every 7 days, during 29 days
Sponsors
BioTech Tools S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical tolerability and safety of the treatment | 3 times during the treatment phase, at week 24 (the end of the study) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of gpASIT+TM on the immunological status of the subjects | visit 1, week 7, week 18 and week 24 | 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. |
| Impact of gpASIT+TM on the clinical status of the subjects | 1 May - 15 August 2010 | 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 . |
Countries
Belgium
Outcome results
None listed