Food allergy hypersensitive
Conditions
Interventions
Patients will receive 10 single rising doses of mCyp c 1 from 6 ng to 60 *g and
5 maintenance doses or placebo. Doses will be administered every week during
the build- up phase (first three doses on
Food allergy
Hypo-allergen
Immunotherapy
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Subject having given a written informed consent before completing any study related procedure. Male or female subject from 18 to 65 years old and in general good health as determined by past medical history and physical examination. For woman of child bearing potential: -a negative urine pregnancy test at screening visit, -the subject must receive/ use a medically effective contraceptive method during the study. Convincing case history of allergy (immediate allergic reaction * 2 hours) to fish ingestion. Specific IgE to fish by both a positive (3mm mean wheal diameter over negative control) SPT to cod extract and an ImmunoCAP * class 2 (0.70 kUA/L) for cod (f3) and rCyp c 1 at screening. Positive DBPCFC with cod at screening visits. Spirometry FEV1 * 80% of predicted values at screening. Subject accepting to comply fully with the protocol.
Exclusion criteria
Exclusion criteria: Placebo-reaction in DBPCFC. Reaction in the last (7th) dose of the DBPCFC. Food anaphylaxis: anaphylactic shock (a score of 2 or 3 on cardiovascular/ neurologic symptoms according to PRACTALL (1): score 2 = drop in blood pressure and/or >20% from baseline, or significant change in mental status- score 3 = cardiovascular collapse, signs of impaired circulation/ unconscious) due to fish intake, both during the past and at screening DBPCFC. Ongoing immunotherapy (IT) with any kind of allergen. Ongoing or previous treatment with omalizumab. Any clinical condition that contraindicates IT (EAACI guidelines) (8): serious immunological diseases, major cardiovascular disease, cancer, chronic infections, lack of compliance and severe psychological disorders. Any significant clinical condition that the investigators judged might hamper the patient*s safety or the study outcomes. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, mental disease, immunological and endocrine disease. Chronic urticaria. Severe atopic dermatitis or non-controlled atopic dermatitis. Ongoing treatment with betablockers, angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor II antagonists (ARA II). Pregnancy or nursing. Uncontrolled asthma (asthma, if present, should be well controlled according to GINA guidelines using any kind of drugs except oral corticosteroids and omalizumab). An FEV1<80% of predicted value during screening spirometry. Subject who has participated in a clinical trial within 3 months prior to this one. Subject with a history of drug or alcohol abuse. Investigators, co-investigators, as well as their children or spouses and all the study collaborators should not be enrolled in the study. Patients with concurrent allergy symptoms can be included if patients can manage without antihistamines and/or leukotriene receptor antagonists five days prior each screening and treatment visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study will be efficacy as determined by the change from baseline in the threshold of fish protein that induces an allergic reaction. This threshold will be assessed by means of a standardized DBPCFC with cod-fish after completion of six months of immunotherapy. Success is defined as a statistically significant change in the threshold dose of protein that provokes a reaction in DBPCFC. | — |
Secondary
| Measure | Time frame |
|---|---|
| The fundamental secondary endpoint will be safety as indicated by clinical safety and tolerability and by the careful recording of adverse events; other surrogates of efficacy will be: physical examination, vital signs, 12-lead ECG and laberoatory evaluations. Secondary outcomes of efficacy are the changes from baseline in the severity of the reaction in the DBPCFC, in SPT reactivity against fish and mCyp c 1 (titrated), in serum specific IgE, IgG, IgG4 and IgA antibodies against fish and rCyp c 1 (ImmunoCAP) and in the biological activity of IgE (stripped basophil histamine release test). | — |
Countries
The Netherlands
Outcome results
None listed