Assessment of the Contribution of Monophosphoryl Lipid A (MPL) to a Grass Pollen Allergy Vaccine

This study has been completed.
Sponsor:
Information provided by:
Allergy Therapeutics
ClinicalTrials.gov Identifier:
NCT00133146
First received: August 22, 2005
Last updated: June 16, 2010
Last verified: September 2009
  Purpose

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. GrassMATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to grass and rye pollen (hay fever).

The tolerability and immunogenicity of GrassMATA (allergen modified with glutaraldehyde and adsorbed to tyrosine) with and without MPL adjuvant (monophosphoryl lipid A, extracted from a bacterial cell surface) is being investigated in this double-blind, randomized Phase IIa study in volunteers allergic to grass and rye pollen.

Additionally, this study will assess residual allergenicity of the modified grass and rye pollen in the product GrassMATAMPL using skin prick testing in volunteers allergic to grass and rye pollen.


Condition Intervention Phase
Type I Hypersensitivity
Biological: Grass MATAMPL
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind Phase IIa Study to Demonstrate the Contribution of MPL to Tyrosine Adsorbed Grass/Rye Pollen Allergoid (Grass MATA) With a Single-Blind Portion to Evaluate the Residual Allergenicity in Skin Test in Volunteers Allergic to Grass and Rye Pollen

Resource links provided by NLM:


Further study details as provided by Allergy Therapeutics:

Primary Outcome Measures:
  • immunological response to GrassMATAMPL versus GrassMATA (grass specific)

Secondary Outcome Measures:
  • immunological response to GrassMATAMPL versus GrassMATA (rye specific)
  • allergenicity of the modified grass pollen allergoid using skin prick testing
  • tolerability of native allergen, modified allergen and tyrosine adsorbents +/- MPL in the skin prick tests
  • tolerability of the different dose steps compared between GrassMATAMPL and GrassMATA treatment groups
  • the tolerability of the cumulative subcutaneous doses compared between GrassMATAMPL and GrassMATA treatment groups
  • safety laboratories
  • vital signs
  • 12-lead electrocardiogram (ECG)
  • number of adverse events
  • number of adverse reactions

Estimated Enrollment: 40
Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a positive skin prick test for grass and rye allergen
  • Specific IgE for grass and rye with class >= 2
  • History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis due to an IgE-mediated allergy to pollen from grass and rye
  • Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile. Females of childbearing potential have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using an acceptable birth control method

Exclusion Criteria:

  • Acute or subacute atopic dermatitis and/or urticaria factitia and/or urticaria due to physical or chemical influence and/or chronic dermatitis
  • Patient has moderate to severe asthma.
  • Visual inspection of the forearms indicates potential problems with the conduct or interpretation of the skin prick test; both forearms must be available for testing
  • History or presence of diabetes, cancer or any clinically significant cardiac, metabolic renal, hematologic diseases or disorders
  • Recent clinically significant history (within 2 years) of hepatic gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders
  • Any clinically significant (as determined by the investigator) abnormal laboratory value at Visit 0
  • Perennial allergens: clinically relevant sensitivity against house dust mites (Dermatophagoides pteronyssinus, Dermatophagoides farinae), molds (Cladosporium cladosporoides, Alternaria alternata, Penicillium chrysogenum, Aspergillus fumigatus) and epithelia (cat [Felis domesticus], dog [Canis familiaris])
  • Patient has clinically relevant sensitivity against the following summer/autumn season flowering plants: Plantago lanceolata (plantain), Atriplex sp. (orache), Urtica dioica (nettle), Artemisia vulgaris (mugwort), Cynodon dactylon (Bermuda grass), or Ambrosia elatior (ragweed).
  • Secondary alteration at the affected organ (i.e. emphysema, bronchiectasis)
  • History of autoimmune diseases and/or rheumatoid diseases
  • Patients who are taking b-blockers for any indication
  • Patients who are not allowed to receive adrenalin
  • Patients in whom tyrosine metabolism is disturbed
  • Presence of a disease with a pathogenesis interfering with the immune response and patient has received medication which could influence the results of this study
  • Documented evidence of acute or significant chronic infection
  • History of anaphylaxis
  • History of angioedema
  • Hypersensitivity to the excipients in the study medication
  • Previous or current hyposensitization therapy with comparable grass allergen extracts
  • Currently using anti-allergy medication and other drugs with antihistaminic activity
  • Patient is pregnant or planning pregnancy and/or lactating
  • Patient has received treatment with preparation containing monophosphoryl lipid A during the past 12 months.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133146

Locations
Canada, Ontario
Allied Research International Inc.
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
Allergy Therapeutics
Investigators
Study Chair: Karl Jürgen Fischer von Weikersthal-Drachenberg, MD Allergy Therapeutics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00133146     History of Changes
Other Study ID Numbers: GrassMATAMPL202, P2DP05004
Study First Received: August 22, 2005
Last Updated: June 16, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Allergy Therapeutics:
Allergy
Specific Immunotherapy

Additional relevant MeSH terms:
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Monophosphoryl lipid A
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014