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Different Doses of Tyrosine Adsorbed Tree Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Tree Pollen

NCT00118612 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-02-09

No results posted yet for this study

Summary

Allergen-specific immunotherapy (SIT), the administration of gradually increasing quantities of an allergen extract to an allergic patient, is a curative approach which directly treats the underlying allergic disease. Tree MATA MPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to tree pollen (hay fever).

The purpose of this double-blind Phase IIb study is to assess the tolerability and immunogenicity of different doses of Tree MATA MPL in volunteers allergic to birch, hazel and alder pollen.

Conditions

  • Type I Hypersensitivity

Interventions

BIOLOGICAL

Tree MATA MPL - Therapeutic Regimen

600, 1600, 4000, 4000 SU/0.5 mL

BIOLOGICAL

Tree MATA MPL - Intermediate dose

300, 600, 1600, 1600 SU/0.5 mL

BIOLOGICAL

Tree MATA MPL - Low dose

300, 300, 300, 300 SU/0.5 mL

BIOLOGICAL

Placebo

L-tyrosine 2% w/v , 4 injections

Sponsors & Collaborators

  • Allergy Therapeutics

    lead INDUSTRY

Principal Investigators

  • Deepen Patel, MD · Allied Research International Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-07-07
Primary Completion
2005-09-15
Completion
2005-09-15
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

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 NCT00118612 on ClinicalTrials.gov