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

NCT02643641 | Completed Phase 2

• 1 other identifier: CS-BM32-004
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypersensitivity

Keywords

Grass pollen allergy; subcutaneous immunotherapy; allergy vaccine; dose regimen

Outcome Measures

Primary Outcomes (1)

• Titer of allergen specific IgG4 antibodies

  approximately 6 months

Secondary Outcomes (4)

• Total nasal symptom score upon pollen challenge (TNSS)

  Change from baseline at 9 months

• Mean daily combined symptom and medication score (SMS)

  2 weeks

• Well-being via visual analog scale

  2 weeks

• Titers of allergen specific IgG antibodies

  Up to 9 months

Other Outcomes (1)

• Incidence of treatment emerging adverse events

  up to 9 months

Study Arms (4)

BM32-3

EXPERIMENTAL

2 placebo injections will be given followed by 3 injections with 20 micrograms each of BM321, BM322, BM325 and BM326

Biological: BM32

BM32-4

EXPERIMENTAL

1 placebo injections will be given followed by 4 injections with 20 micrograms each of BM321, BM322, BM325 and BM326

Biological: BM32

BM32-5

EXPERIMENTAL

5 injections with 20 micrograms each of BM321, BM322, BM325 and BM326 will be given

Biological: BM32

Placebo

PLACEBO COMPARATOR

5 placebo injections (alhydrogel only) will be given

Biological: Placebo

Interventions

BM32 BIOLOGICAL

BM32 is a mixture of 4 different recombinant proteins directed at the major grass pollen allergens, adsorbed on aluminum hydroxide

BM32-3; BM32-4; BM32-5

Placebo BIOLOGICAL

Placebo contains aluminum hydroxide only

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Biomay AG: lead

Study Sites (1)

Vienna Challenge Chamber

Vienna, Vienna, 1150, Austria

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Petra Zieglmayer, MD

  Vienna Challenge Chamber GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 31, 2015
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 19, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)