Assessment of the Contribution of Monophosphoryl Lipid A (MPL) to a Grass Pollen Allergy Vaccine
Condition: Type I Hypersensitivity
MeSH terms: Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Grass MATA MPL
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergy; Specific Immunotherapy