clinical safety and tolerability study of gpasit+tm and gpasit+tm/immunoregulating adjuvant to treat seasonal grass pollen rhinoconjunctivitis

Conditions: Seasonal Allergic Rhinoconjunctivitis

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.


Eligibility criteria:
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