Efficacy and Safety/Tolerability of Grass MATA MPL
Condition: Type I Hypersensitivity
MeSH terms: Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 3

Summary: 
      Grass MATA MPL has been developed by Allergy Therapeutics (UK) Ltd. to provide pre-seasonal
      specific immunotherapy for patients with proven type I hypersensitivity to cross reacting
      grass pollens causing rhinitis and/or conjunctivitis with or without mild to moderate asthma
      bronchiale. The purpose of this study is to compare the efficacy of Grass MATA MPL versus
      placebo in grass-allergic subjects following 4 subcutaneous injections of study medication
      administered before the start of the 2007 grass pollen season.
    

Detailed description: 
      Grass MATA MPL has been developed by Allergy Therapeutics (UK9 Ltd.to provide pre-seasonal
      specific immunotherapy for patients with proven type I hypersensitivity to cross reacting
      grass pollens causing rhinitis and/or conjunctivitis with or without mild to moderate asthma
      bronchiale. Grass MATA MPL is produced as a re-formulation of the Allergy Therapeutics
      product Pollinex Quattro, which has been used in Europe since 1999 on a 'named patient' basis
      (with approximately 65,000 treatment courses containing grass pollens).

      Grass MATA MPL contains an extract of the 13 grass pollens. This extract is chemically
      modified with glutaraldehyde to produce the active ingredient, an allergoid. Such
      modification reduces the reactivity of the extract with IgE antibody. However, a simultaneous
      reduction in other important immunological properties, such as IgG and T cell reactivity is
      not seen. The modified extract is adsorbed to L-tyrosine as a depot formulation. MPL®, a
      purified, detoxified glycolipid derived from the cell walls of Salmonella minnesota, is also
      included in the current product formulation. This excipient/adjuvant is included to increase
      the immunogenic effect of the product and to enhance the switch from an allergen-specific TH2
      to TH1-like T cell profile.

      The current formulation is designed to provide a product that will be efficacious with only 4
      injections, in contrast to the longer schedules currently in use with unmodified extracts.
      The product will also be safer to use than a formulation containing a similar mass of
      unmodified allergen extract as regards its ability to cause severe local allergic reactions
      or anaphylaxis, because of its reduced reactivity with IgE antibody. The modification is
      greater than 75%, so that only a small amount of unmodified allergen is remaining in the
      product.

      The purpose of this study is to compare the efficacy of Grass MATA MPL versus placebo in
      grass-allergic subjects following 4 subcutaneous injections of study medication administered
      before the start of the 2007 grass pollen season.
    

Intervention name(s): Grass MATA MPL; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 4 subcutaneous injections; 4 subcutaneous injections
Other intervention name(s): tyrosine solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergy; Allergoid; Specific Immunotherapy