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

Summary: 
      Ragweed MATAMPL has been developed by Allergy Therapeutics to provide pre-seasonal specific
      immunotherapy for patients with proven type I hypersensitivity to cross reacting ragweed
      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 Ragweed MATAMPL versus
      placebo in ragweed-allergic subjects following 4 subcutaneous injections of study medication
      administered before the start of the 2007 ragweed pollen season
    

Detailed description: 
      Ragweed MATAMPL has been developed by Allergy Therapeutics to provide pre-seasonal specific
      immunotherapy for patients with proven type I hypersensitivity to cross reacting ragweed
      pollens causing rhinitis and/or conjunctivitis with or without mild to moderate asthma
      bronchiale.

      An earlier formulation of Ragweed MATAMPL developed by Allergy Therapeutics (UK), Ltd,
      available commercially in Canada since the 1980's, is 'Pollinex®-R'. 'Pollinex®-R' is
      formulated with modified allergens (allergoids) of ragweed pollen extract adsorbed onto L
      tyrosine at 4% w/v. Related formulations developed by ATL, available commercially in selected
      European countries since the 1970´s on a Named Patient Basis, are 'Pollinex Tree', 'Pollinex
      Grass', 'Pollinex Quattro Trees' (previously known as MATA tree + MPL), and 'Pollinex Quattro
      Grass' (previously known as MATA grass + MPL).

      Ragweed MATAMPL contains an extract of ragweed 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 Ragweed MATAMPL versus placebo in
      ragweed-allergic subjects following 4 subcutaneous injections of study medication
      administered before the start of the 2007 ragweed pollen season.
    

Intervention name(s): Ragweed MATA MPL
Intervention type(s): Biological
Intervention description(s): 4 injections of increasing dose strength:
300 SU/0.5 ml
700 SU/0.5 ml
2000 SU/0.5 ml
6000 SU/0.5 ml
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergy; Allergoid; Specific Immunotherapy