NCT01111279CompletedPhase 1
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
BioTech Tools S.A.2 sites in 1 country27 target enrollmentStarted: March 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Clinical tolerability and safety of the treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Clinical tolerability and safety of the treatment
Time Frame: 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 Outcomes
- Impact of gpASIT+TM on the immunological status of the subjects(visit 1, week 7, week 18 and week 24)
- Impact of gpASIT+TM on the clinical status of the subjects(1 May - 15 August 2010)
Investigators
Study Sites (2)
Loading locations...
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