The aim of this study is to investigate the safety and tolerability of Subcutaneous Immunotherapy treatment (SCIT) with incremental doses of a modified recombinant fish parvalbumin (mCyp c 1) quantified in mass units: To establish a safe dose of the candidate hypo-allergen in human subjects and To study the pharmaco-dynamics of the hypo-allergen administered to human subjects. The study is performed as a placebo-controlled double-blinded randomized trial with 24 fish allergic patients allocated into three different groups of eight.
The aim of the FAST project in general is to develop novel recombinant allergen-based therapeutics for the treatment of food allergy. The chosen approach is to modify recombinant allergens into hypo-allergenic molecules to decrease the risk of anaphylactic side-effects and to allow administration of higher doses leading to better efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
2 patient groups with different doses of allergen.
Allergy Clinic, Gentofte Hospital
Hellerup, Denmark
Safety in the form of number and severity of adverse events
Safety is evaluated by number and severity of adverse events
Time frame: 1 year
Specific IgE
To study the pharmaco-dynamics of the hypo-allergen administered to human subjects i.e. Specific IgE.
Time frame: 1 year
IgG4
Immunologic parameter.
Time frame: 1 year
Skin Prick Test
Pharmaco-dynamics of the hypo-allergen administered to human subjects.
Time frame: 1 Year
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