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

NCT00118625 | Completed Phase 2

• 2 other identifiers: TreeMATAMPL202P2DP05002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 tolerability and immunogenicity of Tree MATA (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 birch and hazel and alder pollen. Additionally, this study will assess residual allergenicity of the modified birch and hazel and alder pollen in the product Tree MATA MPL using skin prick testing in volunteers allergic to birch and hazel and alder pollen.

Conditions

Type I Hypersensitivity

Keywords

Allergy; Specific Immunotherapy; Adjuvant; Allergy Vaccination; Allergenicity

Outcome Measures

Primary Outcomes (1)

• immunological response to Tree MATA MPL versus Tree MATA (birch specific)

Secondary Outcomes (10)

• immunological response to Tree MATA MPL versus Tree MATA (hazel and alder specific)

• allergenicity of the modified tree (birch, alder, hazel) 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 Tree MATA MPL and Tree MATA treatment groups

• the tolerability of the cumulative subcutaneous doses compared between Tree MATA MPL and Tree MATA treatment groups

Interventions

Tree MATA MPL BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Positive skin prick test for birch and hazel and alder allergen
• Positive skin prick test to positive histamine control
• Negative skin prick test to negative control
• Specific IgE for birch as documented by a radioallergosorbent or equivalent test with class ≥ 2
• History of at least 1 season of moderate to severe seasonal rhinoconjunctivitis due to an IgE - mediated allergy to pollen from birch and hazel and alder
• Patients must score on the disease severity questionnaire as moderate or severe.
• Males or non-pregnant, non-lactating females
• Willing and able to attend required study visits
• Able to follow instructions
• Willing and able to give written informed consent

You may not qualify if:

• Acute or subacute atopic dermatitis and/or urticaria factitia and/or urticaria due to physical or chemical influence and/or chronic dermatitis
• 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, or hematologic diseases or disorders
• Recent clinically significant history of hepatic, gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders
• Any clinically significant abnormal laboratory value at Visit 0
• Perennial allergens: clinically relevant sensitivity to house dust mites, molds and epithelia
• Patient has clinically relevant sensitivity to the following summer/autumn season flowering plants: plantain, orache, nettle, mugwort , Bermuda grass, or ragweed.
• Secondary alteration at the affected organ
• History of autoimmune diseases
• Patient is taking ß-blockers for any indication
• Patient who is 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

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (1)

Allied Research International Inc.

Mississauga, Ontario, L4W 1N2, Canada

Location

MeSH Terms

Conditions

Hypersensitivity, Immediate; Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Deepen Patel, MD

  Allied Research International Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 1, 2005
• First Posted: July 12, 2005
• Study Start: July 1, 2005
• Study Completion: September 1, 2005
• Last Updated: June 17, 2010

Record last verified: 2010-06

Locations

CA (1)