FAST- Allergy vaccination for patients with fish allergy for the treatment of fish allergy

• Register: EUCTR
• Last refreshed on: 22 May 2017
• Main ID: EUCTR2015-000276-10-NL
• Date of registration: 09/09/2015
• Prospective Registration: Yes
• Primary sponsor: Academisch Medisch Centrum bij de Universiteit van Amsterdam (AMC)
• Public title: FAST- Allergy vaccination for patients with fish allergy for the treatment of fish allergy
• Scientific title: FAST – Food Allergy Specific ImmunoTherapy A multinational phase IIb study to investigate the efficacy and safety of subcutaneous immunotherapy with a modified fish- parvalbumin given in single rising and maintenance doses to subjects allergic to fish
• Date of first enrolment: 10/11/2015
• Target sample size: 96
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000276-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Denmark, Greece, Iceland, Netherlands, Poland

Contacts

• Name: Clinical Coordinator FAST2015
• Affiliation: Allergy Dpt, 2nd Pediatric Clinic, University of Athens

• Name: Clinical Coordinator FAST2015
• Affiliation: Allergy Dpt, 2nd Pediatric Clinic, University of Athens

Key inclusion & exclusion 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 96
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Not possible to specify

Food allergy to fish

Intervention(s)

Product Name: FAST fish mCyp c 1
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: mCyp c 1
Current Sponsor code: ORG28081
Other descriptive name: MCYP C 1
Concentration unit: g/ml gram(s)/millilitre
Concentration type: equal
Concentration number: 0.00015-
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: To evaluate the safety of SCIT treatment with mCyp c 1 and determine any possible changes in the severity of the reaction during the pre- and post-treatment DBPCFC (double blind placebo controled food challenge) with fish, in the SPT (skin prick test) reactivity to fish, in specific IgE, IgA, IgG, IgG4 antibodies against fish and rCyp c 1 (recombinant carp parvalbumin) and in the biological activity of IgE, between the active and placebo study groups.

Main Objective: To evaluate the efficacy of a SCIT (subcutaneous immunotherapy)-treatment with a mutant recombinant fish-parvalbumin (mCyp c1, carp parvalbumin) quantified in mass units and formulated in a solution with alum, in subjects with fish-allergy.

Primary end point(s): 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 (double blind placebo controlled food challenge) with cod-fish after completion of six months of immunotherapy (SCIT). Success is defined as a statistically significant change in the threshold dose of protein that provokes a reaction in DBPCFC.

Timepoint(s) of evaluation of this end point: The time point for each patient will be 2 weeks after the last maintenance dose of the SCIT. At that time point each patient will be subjected to a post-treatment DBPCFC.

Secondary Outcome(s)

Secondary end point(s): 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 safety will be: physical examination, vital signs, 12-Lead ECG and laboratory evaluations (complete blood count, biochemical tests, urine analysis and urine pregnancy test).
Secondary outcomes of efficacy are the changes from baseline in the severity of the reaction in the post DBPCFC (as compared with pre-treatment), in SPT reactivity against fish and mCyp c 1 (titrated), in serum specific IgE, IgG, IgG4 and IgA antibodies against rCyp c 1 (CAP) and in the biological activity of IgE (stripped basophil histamine release test).

Timepoint(s) of evaluation of this end point: Safety will be monitored throughout the study.
For efficacy, the time point for each patient will be 2 weeks after the last maintenance dose of the SCIT. At that time point each patient will be subjected to a DBPCFC. Before the food challenge patients will be subjected to blood withrawl, urine sample and skin prick tests to assess the secondary end points (both in terms of safety and efficacy).

Secondary ID(s)

2015-000276-10-IS

FAST2015

Source(s) of Monetary Support

EU 7.th Framework Programme