Safety of gpASIT+TM Subcutaneously Administered to Hay Fever Patients With or Without Immunoregulating Adjuvant

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Status and phase

Completed

Phase 2

Conditions

Hay Fever

Treatments

Biological: gpASIT+TM

Biological: gpASIT+TM + adjuvant

Study type

Interventional

Funder types

Industry

Identifiers

NCT01506375

gpASIT006

2011-004486-33 (EudraCT Number)

Details and patient eligibility

About

The aim of the study is to compare the safety, clinical tolerability, immunogenicity and efficacy of gpASIT+TM (grass pollen peptides) alone and combined with an immunoregulating adjuvant, in a short course administration (5 injections over 4 weeks).

Enrollment

24 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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 medical history of moderate to severe 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 (IgE > 0.7 kU/l) [using recombinant mixture of rPhl p1 and rPhl p5b Phleum pratense (g213)]
Subjects never treated by immunotherapy or subjects for whom the immunotherapy ended at December 31, 2009 and who had as well moderate to severe symptoms in the two previous years (2010 and 2011)

Exclusion criteria

Subjects with current immunotherapy and subjects who underwent a previous immunotherapy within the last 2 years
Participation in another clinical trial and/or treatment with an experimental drug within the last 3 months
A history of hypersensitivity to the excipients of investigational products
Subjects with perennial asthma (regular intake of inhaled corticosteroids outside the pollen season: consumption on a daily base or patients who are taking a reliever more than twice a week)
Subjects with severe seasonal asthma requiring long acting beta agonist AND inhaled steroid treatment
Subjects with a VC < 80% and a FEV1 < 70% of predicted value at the screening visit
Subjects symptomatic to perennial inhalant allergens who should need antihistamine drug or systemic corticoids to relieve allergic symptoms during the treatment period
Subjects with documented evidence of chronic sinusitis (as determined by Investigator)
Subjects with rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent...)
Subjects with a history of renal disease or chronic hepatic disease
Subject with malignant disease, autoimmune disease
Any chronic disease, which may impair the subject's ability to participate in the trial
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)
Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial (screening visit)
Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial (screening visit)
Subject with febrile illness (> 37.5°C, oral)
A known positive serology for HIV-1/2, HBV or HCV
Subjects that are immunocompromised by medication or illness, have 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
Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method
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