FAST Fish Phase IIb Clinical Trial for the Treatment of Fish Allergy by Subcutaneous Immunotherapy
Condition: Food Allergy to Fish
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase IIb clinical trial to investigate the efficacy and safety of subcutaneous
      immunotherapy with a modified parvalbumin called mCyp c 1 for the treatment of fish allergy
      to subjects allergic to fish.
    

Detailed description: 
      Fish allergy is a persistent food allergy (usually lifelong) which can be life threatening
      due to the danger for anaphylaxis (severe allergic reaction) upon accidental exposure to
      fish. Until today there is no curative treatment for fish allergy. The only treatment is
      avoidance. Patients with fish allergy have to avoid fish of all types and carry an adrenaline
      autoinjector and rescue medication, in case of accidental exposure to fish. That way patients
      with fish allergy have to continuously control what they are eating and this causes a great
      deal of stress and impacts their quality of life.

      The major allergen responsible for fish allergy is the protein parvalbumin. It is recognized
      by the vast majority (96-100%) of fish allergic patients.

      During the past, treatment of food allergy with immunotherapy was successful but dangerous,
      due to serious side effects (anaphylaxis).

      A novel biotechnological product, a recombinant hypoallergenic parvalbumin, called mCyp c 1,
      is used for the first time in a phase IIb clinical trial, to test the efficacy of
      subcutaneous immunotherapy for the treatment of fish allergy. The investigational medicinal
      product mCyp c1, is based on the recombinant wild type carp parvalbumin (rCyp c 1) and is the
      result of site directed mutagenesis, by which the disruption of the two calcium binding sites
      of carp parvalbumin is performed. The modified parvalbumin mCyp c 1, is both hypoallergenic
      and immunogenic. That way it is a promising molecule for the safe and effective treatment of
      fish allergy.

      This molecule has proven to be safe in a phase I/IIa study that has been performed, during
      which mCyp c 1 was administered with subcutaneous injections. During this study only local
      reactions at the injection site were observed. There were no observed systemic reactions.
      Even more, there were clear indications that mCyp c 1 was recognized by the immune system.
      The results of this phase I/IIa study guarantee the necessity of a phase IIb clinical trial
      with mCyp c 1, in order to study the efficacy of this modified parvalbumin in the treatment
      of fish allergy.
    

Intervention name(s): FAST fish mCyp c 1; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Subcutaneous immunotherapy; Subcutaneous immunotherapy
Other intervention name(s): mCyp c 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: fish allergy; parvalbumin; immunotherapy; mCyp c 1