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

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ClinicalTrials.gov Identifier: NCT00118612
Recruitment Status : Completed
First Posted : July 12, 2005
Last Update Posted : June 17, 2010
Information provided by:
Allergy Therapeutics

July 1, 2005
July 12, 2005
June 17, 2010
July 2005
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immunological response to the three Tree MATA MPL treatment arms compared to placebo (birch specific)
Same as current
Complete list of historical versions of study NCT00118612 on ClinicalTrials.gov Archive Site
  • tolerability of different subcutaneous doses
  • tolerability of the cumulative subcutaneous doses
  • clinical chemistry and hematology
  • number of adverse events
  • number of adverse reactions
  • immunological response to the three Tree MATA MPL treatment arms compared to placebo (alder and hazel specific)
Same as current
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Different Doses of Tyrosine Adsorbed Tree Pollen Allergoid With Monophosphoryl Lipid A (MPL) in Patients Sensitized to Tree Pollen
A Double-Blind Phase IIb Study to Evaluate the Safety and Efficacy of Different Doses of Tyrosine Adsorbed Birch + Hazel + Alder Pollen Allergoid With MPL® in Patients Sensitized to Birch, Hazel, Alder Pollen

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.

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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Type I Hypersensitivity
Biological: Tree MATA MPL
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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Inclusion Criteria:

  • Patients must have a 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 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, hazel, and alder
  • Patients must score on the disease severity questionnaire as moderate or severe.
  • Males or non-pregnant, non-lactating females
  • Patients who are normally active and otherwise judged to be in good health
  • Patients must be willing and able to attend required study visits.
  • Patients must be able to follow instructions.
  • Patients must be willing and able to give written informed consent and must provide this consent.

Exclusion Criteria:

  • 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 1
  • 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, Parietaria judaica, Bermuda grass, or ragweed.
  • Secondary alteration at the affected organ
  • History of autoimmune diseases and/or rheumatoid diseases
  • Patient is taking ß-blockers for any indication including eye drops
  • 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
  • Acute or significant chronic infection
  • History of anaphylaxis
  • Documented history of angioedema
  • Hypersensitivity to excipients in the study medications
  • Previous or current immunotherapy with comparable tree allergen extracts
  • Currently using anti-allergy medication and other drugs with antihistaminic activity
  • Patients currently participating in a clinical trial or who have been exposed to study medication within the last 30 days
  • Patients who cannot communicate reliably with the Investigator or who are not likely to cooperate with the requirements of the study
  • Patient is pregnant or planning pregnancy and/or lactating
  • Patient has received treatment with preparation containing MPL during the past 12 months
  • Concurrent use of any prohibited medication(s), as listed in the study protocol, or inadequate washout of any medication
  • Any systemic disorder that could interfere with the evaluation of the study medication(s)
  • Clinical history of drug or alcohol abuse, at the Investigator's discretion, that would interfere with the patient's participation in the study
  • Study site staff or immediate relatives of study site staff or other individuals who would have access to the clinical study protocol
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Allergy Therapeutics
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Principal Investigator: Deepen Patel, MD Allied Research International Inc.
Allergy Therapeutics
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP