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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Allergy Therapeutics
ClinicalTrials.gov Identifier:
NCT00109759
First received: May 3, 2005
Last updated: June 16, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Type I Hypersensitivity
Biological: RagweedMATAMPL
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Allergy Therapeutics:

Primary Outcome Measures:
  • Safety and tolerability

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

Estimated Enrollment: 15
Study Start Date: May 2005
Estimated Study Completion Date: June 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00109759

Locations
Canada, Ontario
Allied Research International Inc.
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
Allergy Therapeutics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00109759     History of Changes
Other Study ID Numbers: RagweedMATAMPL102, P1DP05002
Study First Received: May 3, 2005
Last Updated: June 16, 2010
Health Authority: Canada: Health Canada

Keywords provided by Allergy Therapeutics:
allergy
allergoid
specific immunotherapy
ragweed

Additional relevant MeSH terms:
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on October 23, 2014