We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Different Pre-seasonal BM32 Dosings on the Induction of a Protective Immune Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02643641
Recruitment Status : Completed
First Posted : December 31, 2015
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
BM32 is a product for immunotherapy of grass pollen allergies. It consists of 4 different recombinant proteins (BM321, BM322, BM325 and BM326) adsorbed on alhydrogel. This prospective, double-blind. placebo controlled, mono-centric trial investigates the levels of allergen specific IgG antibodies following 3, 4 or 5 subcutaneous injections before the grass pollen season.

Condition or disease Intervention/treatment Phase
Hypersensitivity Biological: BM32 Biological: Placebo Phase 2

Detailed Description:

The aim of this study is to further optimize the immunization schedule by

  • moving the last injection into beginning of the grass pollen season for all study arms in order to ensure highest possible IgG4 levels when they are needed - i.e. at the peak of the grass pollen season,
  • administration of more than 3 pre-seasonal injections in order to build up sufficiently high levels of IgG4 already in the first year of treatment , and
  • dosing during the beginning of the grass pollen season to establish safety in this setting The effect of such optimized immunization schedule on the induction of an IgG4 immune response as a surrogate parameter for efficacy will be studied. The Total Nasal Symptom Score (TNSS) before and after the treatment and Combined Symptom-Medication Score (SMS) during the grass pollen season will be evaluated as secondary endpoints. This will allow intra-individual comparison of seasonal symptom data and responsiveness in the chamber setting.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Study to Evaluate the Effect of Different Pre-seasonal BM32 Dosing Schedules on the Rapid Induction of a Protective IgG Immune Response
Study Start Date : January 2016
Primary Completion Date : October 2016
Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: BM32-3
2 placebo injections will be given followed by 3 injections with 20 micrograms each of BM321, BM322, BM325 and BM326
Biological: BM32
BM32 is a mixture of 4 different recombinant proteins directed at the major grass pollen allergens, adsorbed on aluminum hydroxide
Experimental: BM32-4
1 placebo injections will be given followed by 4 injections with 20 micrograms each of BM321, BM322, BM325 and BM326
Biological: BM32
BM32 is a mixture of 4 different recombinant proteins directed at the major grass pollen allergens, adsorbed on aluminum hydroxide
Experimental: BM32-5
5 injections with 20 micrograms each of BM321, BM322, BM325 and BM326 will be given
Biological: BM32
BM32 is a mixture of 4 different recombinant proteins directed at the major grass pollen allergens, adsorbed on aluminum hydroxide
Placebo Comparator: Placebo
5 placebo injections (alhydrogel only) will be given
Biological: Placebo
Placebo contains aluminum hydroxide only


Outcome Measures

Primary Outcome Measures :
  1. Titer of allergen specific IgG4 antibodies [ Time Frame: approximately 6 months ]

Secondary Outcome Measures :
  1. Total nasal symptom score upon pollen challenge (TNSS) [ Time Frame: Change from baseline at 9 months ]
    Sensitivity to a grass pollen challenge in an environmental exposure chamber

  2. Mean daily combined symptom and medication score (SMS) [ Time Frame: 2 weeks ]
  3. Well-being via visual analog scale [ Time Frame: 2 weeks ]
  4. Titers of allergen specific IgG antibodies [ Time Frame: Up to 9 months ]

Other Outcome Measures:
  1. Incidence of treatment emerging adverse events [ Time Frame: up to 9 months ]
    Frequency and severity of IMP related adverse events


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subjects are grass pollen allergic but otherwise healthy. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests.
  • They are aged 18 to 60 years inclusive.
  • They have a history of seasonal allergic rhinitis (SAR) to grass pollen.
  • They have a normal electrocardiogram without clinically significant abnormalities.
  • They exhibit a moderate to severe response to approximately 1500 grass pollen grains/m3 after the first 2h in the Vienna Challenge Chamber, which is defined as a nasal symptom score (TNSS) of at least 6. (Nasal symptom score is the sum of nasal obstruction, rhinorrhoea, itchy nose and sneezing, each of which have been scored on a scale from 0 to 3).
  • They have a positive skin prick test with a wheal diameter >5mm for grass pollen extract at the screening visit.
  • They have a positive serum IgE test for timothy grass pollen and to rPhl p 1+rPhl p 5 at the screening visit (ImmunoCAP ≥3.5 kUA/l; i.e ≥ class 2)..
  • There are no conditions or factors which would make the subject unlikely to be able to stay in the chamber for 6 hours.
  • They are capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form.
  • They are available to complete all study measurements

Exclusion Criteria:

  • Sensitization to Phl p 7
  • Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method (pregnancy to be controlled by a pregnancy dipstick test).
  • On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection which in the Responsible Physician's opinion renders the subject unsuitable for participation in the study.
  • Any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function.
  • The subject is concurrently participating or has participated in any clinical study in the previous month.
  • Participation in a SIT trial for grass pollen allergy in the three years prior to this study.
  • Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643641


Locations
Austria
Vienna Challenge Chamber
Vienna, Austria, 1150
Sponsors and Collaborators
Biomay AG
Investigators
Principal Investigator: Petra Zieglmayer, MD Vienna Challenge Chamber GmbH
More Information

Responsible Party: Biomay AG
ClinicalTrials.gov Identifier: NCT02643641     History of Changes
Other Study ID Numbers: CS-BM32-004
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Biomay AG:
Grass pollen allergy
subcutaneous immunotherapy
allergy vaccine
dose regimen

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents