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

NCT02643641 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2017-01-19

No results posted yet for this study

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

Interventions

BIOLOGICAL

BM32

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

BIOLOGICAL

Placebo

Placebo contains aluminum hydroxide only

Sponsors & Collaborators

  • Biomay AG

    lead INDUSTRY

Principal Investigators

  • Petra Zieglmayer, MD · Vienna Challenge Chamber GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-10-31
Completion
2017-01-31

Countries

  • Austria

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02643641 on ClinicalTrials.gov