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

Sponsored by:	Allergy Therapeutics
Information provided by:	Allergy Therapeutics
ClinicalTrials.gov Identifier:	NCT00109759

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
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:

MedlinePlus related topics: Allergy

Drug Information available for: Tyrosine

U.S. FDA Resources

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

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

Study ID Numbers:	RagweedMATAMPL102, P1DP05002
Study First Received:	May 3, 2005
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00109759 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Allergy Therapeutics:

allergy
allergoid
specific immunotherapy
ragweed

Study placed in the following topic categories:

Monophosphoryl lipid A
Hypersensitivity
Immunologic Factors
Adjuvants, Immunologic

Hypersensitivity, Immediate
Tyrosine
Healthy

Additional relevant MeSH terms:

Monophosphoryl lipid A
Hypersensitivity
Immunologic Factors
Immune System Diseases

Physiological Effects of Drugs
Adjuvants, Immunologic
Hypersensitivity, Immediate
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 03, 2009