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

NCT00133146 | Completed Phase 2 FDA Drug

• 2 other identifiers: GrassMATAMPL202P2DP05004
• Study Type: interventional
• Target: 41
• 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. GrassMATAMPL has been developed to provide pre-seasonal specific immunotherapy for patients with an allergy to grass and rye pollen (hay fever). The tolerability and immunogenicity of GrassMATA (allergen modified with glutaraldehyde and adsorbed to tyrosine) with and without MPL adjuvant (monophosphoryl lipid A, extracted from a bacterial cell surface) was investigated in this double-blind, randomized Phase IIa study in volunteers allergic to grass and rye pollen. Additionally, this study assessed residual allergenicity of the modified grass and rye pollen in the product GrassMATAMPL using skin prick testing in volunteers allergic to grass and rye pollen.

Conditions

Type I Hypersensitivity

Keywords

Allergy; Specific Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Immunological response to GrassMATAMPL versus GrassMATA (grass specific)

  Immunoglobulin levels: Timothy Grass specific IgG, Timothy Grass specific IgG1, Timothy Grass specific IgG4, and Timothy Grass specific IgE

  14 days

Secondary Outcomes (18)

• Immunological response to Grass MATA MPL versus Grass MATA in volunteers allergic to grass and rye pollen

  up to 10 weeks

• Tolerability of native allergen, modified allergen and tyrosine adsorbents with and without MPL® in the skin prick tests

  >= 30 min to 6 hours post application

• Tolerability of the cumulative subcutaneous doses compared between Grass MATA MPL and Grass MATA.

  6 weeks

• Tolerability of the different dose steps compared between GrassMATAMPL and GrassMATA treatment groups.

  Up to 24 hours post-administration

• Measure of concentration of Albumin (g/L)

  10 Weeks

Study Arms (2)

Grass MATA MPL

EXPERIMENTAL

300 SU/0.5 mL Grass MATA MPL (Visit 2); 800 SU/0.5 mL Grass MATA MPL (Visit 4); 2000 SU/0.5 mL Grass MATA MPL (Visit 6)

Biological: Grass MATA MPL

Grass MATA

ACTIVE COMPARATOR

300 SU/0.5 mL Grass MATA (Visit 2); 800 SU/0.5 mL Grass MATA (Visit 4); 2000 SU/0.5 mL Grass MATA (Visit 6);

Biological: Grass MATA MPL

Interventions

Grass MATA MPL BIOLOGICAL

Grass MATA; Grass MATA MPL

Eligibility Criteria

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

You may qualify if:

• Patients had a positive skin prick test for grass and rye allergen (wheal \>= 5 mm greater than the negative control)
• Patients had a positive skin prick test to positive histamine control with a wheal (longest) diameter \>= 3 mm.
• Patients had a negative skin prick test to negative control; redness, but no wheal was acceptable.
• Specific IgE for grass and rye as documented by radioallergosorbent (RAST) 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 grass and rye
• Patients scored moderate or severe in the disease severity questionnaire
• Males or non-pregnant, non-lactating females who are post-menopausal or naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Postmenopausal was defined as at least 12 months natural spontaneous amenorrhea, or at least 6 weeks following surgical menopause (bilateral oophorectomy). Females of childbearing potential were required to have a confirmed absence of pregnancy according to a negative urine pregnancy test and were required to be using one of the following acceptable birth control methods:
• Intrauterine device (IUD) in place for at least 90 days
• Barrier method (condom or diaphragm) with spermicide
• Stable hormonal contraceptive for at least 90 days prior to study and through study completion
• Abstinence
• Non-heterosexual lifestyle
• Vasectomised partner for at least 90 days.
• Patients were normally active and otherwise judged to be in good health on the basis of medical history, physical examination, and routine laboratory tests.
• Patients were willing and able to attend required study visits.

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
• Patient has moderate to severe asthma. Patients with mild asthma requiring use of bronchodilators as needed were allowed as long as they did not have significant worsening with seasonal exposure to grass pollen
• 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 (insulin dependent and non-dependent), cancer or any clinically significant cardiac, metabolic renal, hematologic diseases or disorders
• Recent clinically significant history (within 2 years) of hepatic gastrointestinal, dermatologic, venereal, neurologic or psychiatric diseases or disorders
• Any clinically significant (as determined by the investigator) abnormal laboratory value at Visit 0
• Clinically relevant sensitivity to any of the following perennial allergens: house dust mites (Dermatophagoides pteronyssinus, Dermatophagoides farinae), molds (Cladosporium cladosporoides, Alternaria alternata, Penicillium chrysogenum, Aspergillus fumigatus) and epithelia (cat \[Felis domesticus\], dog \[Canis familiaris\])
• Patient had clinically relevant sensitivity determined by a positive case history, skin prick test wheal size \>= 3 mm in diameter greater than the negative control, or RAST test with class \>= 2 against the following summer/autumn season flowering plants: Plantago lanceolata (plantain), Atriplex sp. (orache), Urtica dioica (nettle), Artemisia vulgaris (mugwort), Cynodon dactylon (Bermuda grass), or Ambrosia elatior (ragweed).
• Secondary alteration at the affected organ (i.e. emphysema, bronchiectasis)
• History of autoimmune diseases and/or rheumatoid diseases
• Patients who are taking b-blockers for any indication
• Patients who are not allowed to receive adrenalin
• Disorder of tyrosine metabolism (especially in the case of alcaptonuria, tyrosinemia).
• Presence of a disease with a pathogenesis interfering with the immune response and had 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

• Karl Jürgen Fischer von Weikersthal-Drachenberg, MD

  Allergy Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind with a single-blind component
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2005
• First Posted: August 23, 2005
• Study Start: September 12, 2005
• Primary Completion: November 23, 2005
• Study Completion: November 23, 2005
• Last Updated: July 13, 2021

Record last verified: 2021-07

Locations

CA (1)