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Safety and Dose Finding Trial of BM32 in Subjects Suffering From Grass Pollen Allergy

NCT01445002 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2013-01-14

No results posted yet for this study

Summary

The study will evaluate the dose response of immunotherapy against grass pollen allergy using the recombinant grass pollen vaccine BM32. Efficacy will be analyzed by:

* skin prick testing
* grass pollen inhalation challenge
* antibody responses. In addition, the safety of subcutaneous application of BM32 will be evaluated.

Conditions

  • Grass Pollen Allergy

Interventions

BIOLOGICAL

BM32

Subcutaneous injection of 10 micrograms each of the BM32 components adsorbed on 0.3 mg of aluminum hydroxide every 4 week for a total of 3 injections

BIOLOGICAL

BM32

Subcutaneous injection of 20 micrograms of each of the BM32 components adsorbed on 0.6 mg of aluminum hydroxide every 4 weeks for a total of 3 injections

BIOLOGICAL

BM32

Subcutaneous injection of 40 micrograms of each of the BM32 components adsorbed on 1.2 mg of aluminum hydroxide every 4 weeks until a total of 3 injections

BIOLOGICAL

Placebo

Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every 4 weeks until 3 injections

Sponsors & Collaborators

  • Biomay AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-03-31
Completion
2012-10-31

Countries

  • Austria

Study Locations

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Entities

Drugs

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 NCT01445002 on ClinicalTrials.gov