STUDY ON THE SAFETY AND EFFICACY OF BM32, A VACCINE FOR IMMUNOTHERAPY OF GRASS POLLEN ALLERGY

Conditions: Grass pollen allergy
Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

Registration Number: EUCTR2012-000442-35-AT

Lead Sponsor: Biomay AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

In(1).Positive history of grass pollen allergy, positive skin prick test reaction to grass pollen extract, grass pollen allergen-specific IgE and rPhl p 1/rPhl p 5-specific IgE (at least 3.5 kUA/L) at the at the screening visit or within 12 months prior to the screening visit.
In(2).Moderate to severe symptoms of grass pollen allergy during pollen peak in the baseline period (exact definition of this criterion is specified in the study reference manual (SRM))
In(3).Age between 18 and 60 years (m/f)
In(4).Subjects must have a standard health care insurance
In(5).Subject must appear capable to understand and comply with all relevant aspects of the study protocol
In(6).Subject must be available during the study period to complete all treatments and assessments

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Ex(1).symptomatic perennial allergies or symptomatic seasonal coallergies
during the grass pollen season
Ex(2).atopic dermatitis
Ex(3).pregnancy or breast feeding
Ex(4).women with childbearing potential who are not using a medically accepted birth control method
Ex(5).autoimmune diseases, immune defects including immuno- suppression, immune-complex-induced immunopathies
Ex(6).contra-indication for adrenaline
Ex(7).severe general maladies, malignant diseases
Ex(8).patients under long-term treatment with systemic corticosteroids, immuno-suppressive drugs, tranquilizers or psychoactive drugs
Ex(9).contra-indications for skin prick testing such as: skin inflammation in the test area, urticaria facticia.
Ex (10). asthma not controlled by low dose inhaled corticosteroids. This means that Patients with a history of concomitant asthma should have a FEV1 > 70% at inclusion. Patients without a history of asthma should have FEV1 >70% or a PEF > 80% at inclusion
Ex(11).Chronic use of beta-blockers
Ex(12).participation in another clinical trial within one month prior to the study; however, participation during the previous month solely in the form of blood donation and/or without other interventions will be acceptable
Ex(13).patients who participated in a pollen SIT trial or received marketed
pollen SIT in 2 years prior to study
Ex(14).patients who had a previous grass pollen SIT or have participated in
a clinical trial of grass pollen SIT
Ex(15).risk of non-compliance with the study procedure and restrictions
(e.g. with alcohol, drug or medication abuse within the past year)
Ex(16).Use of prohibited medication prior to Screening (Visit 1) and throughout the study:
o Depot corticosteroids – 12 weeks prior to V1
o Oral corticosteroids – 8 weeks prior to V1
o High –dose inhaled corticosteroids – 4 weeks prior to V1
Ex(17).Use of anti-histamines three days prior to V1 or V2
Ex(18). patients with nasal polyposis
Ex(19). patients sensitized to Phl p 7
(specific IgE to Phl p 7 and/or Bet v 4 > 0,35 kUA/L)