NCT00133146

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

Double-Blind Phase 2a Study to Demonstrate the Contribution of MPL to Tyrosine Adsorbed Grass/Rye Pollen Allergoid With a Single-Blind Portion to Evaluate Residual Allergenicity in Skin Test in Volunteers Allergic to Grass & Rye Pollen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Allergy Therapeutics · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Double-blind Phase IIa study with a single-blind component, to evaluate skin tests allergenicity and to demonstrate the contribution of MPL® to tyrosine adsorbed grass/rye pollen allergoid (Grass MATA) in volunteers allergic to grass and rye pollen. Volunteers underwent skin prick tests with 12 different solutions and then were randomized to receive 3 subcutaneous injections of either Grass MATA MPL or Grass MATA over approximately 14-day intervals for total study duration of approximately 67 days. Enrollment was planned for 40 patients, 20 in each active treatment group. Data from 41 patients who completed the single blind portion of the study and from 40 randomized patients who took part in the double blind portion of the study were analyzed and included in the study. Screening was performed at Visit 0, then subjects fulfilling all inclusion/exclusion criteria underwent a series of skin prick tests to evaluate the tolerability of native allergen, modified allergen and tyrosine adsorbates with and without MPL® (Visit 1, single-blind portion of the study). At Visit 2, subjects were randomized 1:1 to receive either Grass MATA MPL or Grass MATA and received the first injection of treatment. The dosing regimen consisted of three 0.5 mL subcutaneous injections of increasing strengths and was the same for both treatment groups. Patients were asked to remain in the clinic for an observation period of 30 to 45 minutes following study drug administration in order to record adverse reactions associated. The second and third injections of treatment were administered at Visit 4 and Visit 6. Each dosing visit occurred at least 14 days after the previous one. Safety follow-up were performed 7-8 days after each dosing, at Visit 3, 5 and 7. Subjects terminated the study after completion of Visit 8 (Post-treatment visit). To assess the immunological response to Grass MATA MPL versus Grass MATA blood test were performed at baseline (Visit 0), after the first administration (Visit 3) and at the end of the study (Visit 8). Safety and tolerability of the different allergens used during prick test and of Grass MATA MPL versus Grass MATA were also be evaluated.

Conditions

• Type I Hypersensitivity

Interventions

Type	Name	Description
BIOLOGICAL	Grass MATA MPL

Timeline

• Start date: 2005-09-12
• Primary completion: 2005-11-23
• Completion: 2005-11-23
• First posted: 2005-08-23
• Last updated: 2021-07-13

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study