Evaluation of Safety and Tolerability of Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL (Monophosphoryl Lipid A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00109759
Recruitment Status : Withdrawn
First Posted : May 4, 2005
Last Update Posted : June 17, 2010
Information provided by:
Allergy Therapeutics

Brief Summary:
The safety and tolerability of tyrosine adsorbed ragweed pollen allergoid with monophosphoryl lipid A (MPL) will be evaluated. For this purpose, a total of 4 injections of either increasing doses of the study drug or placebo (tyrosine) will be administered in 7-day intervals to healthy volunteers.

Condition or disease Intervention/treatment Phase
Type I Hypersensitivity Biological: RagweedMATAMPL Phase 1

Detailed Description:

RagweedMATAMPL (tyrosine adsorbed ragweed pollen allergoid with monophosphoryl lipid A (MPL®)) has been developed to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to ragweed pollen. MPL (Monophosphoryl Lipid A), a purified, detoxified glycolipid derived from the cell wall of Salmonella minnesota, is included in the product formulation as an adjuvant to increase the immunogenic effect of the product and to enhance the switch from an allergen-specific TH2 to a TH1-like profile.

The ragweed pollen extract is modified with glutaraldehyde to produce the active ingredient, an allergoid. This modification reduces the reactivity of the extract with IgE antibody, thus reducing the risk of side effects. However, a simultaneous reduction in other important immunological properties, such as IgG and T cell reactivities is not seen.

This will be a phase I, double-blind, placebo-controlled study to evaluate the safety and tolerability of RagweedMATAMPL in healthy volunteers. Fifteen (15) volunteers will be randomized to receive up to 4 subcutaneous injections of either increasing doses of RagweedMATAMPL or Placebo over 7 day intervals.

Study Type : Interventional  (Clinical Trial)
Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind Phase I Study to Evaluate the Safety and Tolerability of Tyrosine Adsorbed Ragweed Pollen Allergoid With MPL® in Healthy Volunteers.
Study Start Date : May 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Primary Outcome Measures :
  1. Safety and tolerability

Secondary Outcome Measures :
  1. Tolerability of different subcutaneous doses
  2. Tolerability of the cumulative subcutaneous dose
  3. Clinical chemistry, hematology, respiratory rate, and ECG before and after each dose and at the end of the study

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Non-smoker and not using any nicotine products
  • Negative skin prick test with a standard panel of marker allergen extracts (including ragweed allergen extract)
  • Specific IgE for ragweed with class = 0
  • No clinical history of IgE-mediated allergic diseases
  • Subject agrees not to use any medication or herbal products during the study
  • Males or non-pregnant, non-lactating females who are post-menopausal, naturally or surgically sterile, or who agree to use effective contraceptive methods throughout the course of the study.
  • Subjects who are normally active and otherwise judged to be in good health on the basis of medical history, physical examination, routine laboratory tests and an infection screen
  • Subjects must be willing and able to attend required study visits.
  • Subjects must be able to follow instructions.

Exclusion Criteria:

  • Clinical history or presence of acute or subacute atopic dermatitis, chronic dermatitis, urticaria factitia, or urticaria due to physical/chemical influence.
  • Clinical history or presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, dermatologic, venereal, hematologic, neurologic or psychiatric diseases or disorders.
  • Any clinically significant (as determined by the Investigator) abnormal laboratory value at Visit 1
  • Clinical history of auto-immune diseases or rheumatoid diseases.
  • Contraindication to adrenaline
  • History of asthma
  • Subject has used any prescription medications within 14 days or over-the-counter medications, including herbal products, within 2 days prior to Screening or will likely use any medication(s) or listed product(s) during the study.
  • Subject has disorder of tyrosine metabolism
  • Subject with diseases with a pathogenesis interfering with the immune response and who has received medication which could influence the results of this study
  • Subject has acute or chronic infection
  • Clinical history of anaphylaxis
  • Clinical history of angioedema
  • Clinical history of hypersensitivity to the excipients of the study medication
  • History of immunotherapy with ragweed allergen extracts
  • Current therapy with ß-blockers
  • Currently receiving anti-allergy medication or other drugs with an antihistaminic activity
  • Subject has a positive screen for cotinine or drugs of abuse at Visit 1
  • Subject has a positive saliva alcohol test at Visit 1
  • Subject participated in a clinical trial with a new chemical substance within the last 12 months
  • Subject cannot communicate reliably with the Investigator or is not likely to cooperate with the requirements of the study
  • Subject is pregnant or lactating
  • Clinically relevant abnormal vital signs or respiratory rate at the Screening Visit
  • Subject received treatment with a preparation containing MPL® during the past 12 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00109759

Canada, Ontario
Allied Research International Inc.
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
Allergy Therapeutics Identifier: NCT00109759     History of Changes
Other Study ID Numbers: RagweedMATAMPL102
First Posted: May 4, 2005    Key Record Dates
Last Update Posted: June 17, 2010
Last Verified: June 2010

Keywords provided by Allergy Therapeutics:
specific immunotherapy

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