Clinical trial NCT02017626: FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.
Official title: FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fish Allergy
Keywords: Fish allergy
immunotherapy
hypoallergen
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
name: Odense University Hospital
First posted: 2013-12-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male or female subject from 18 to 65 years old and in general good health as determined by past medical history and physical examination.
* Case history of allergy to fish ingestion.
* Specific IgE to fish by either a positive SPT to cod fish extract or an ImmunoCAP to cod fish above 0.70 kUA/L,(Class 2) at screening.
* Positive Double blind placebo-controlled Food challenge (DBPCFC) with fish within the last two years.
* FEV1 at least 80% of predicted values at screening.
* Subject accepting to comply fully with the protocol.
* For woman of child bearing potential:

  * a negative urine pregnancy test at screening visit,
  * subject must receive a medically effective contraceptive method during the study

Exclusion Criteria:

* Food Anaphylactic Reaction: anaphylactic shock due to fish intake.
* Specific IgE (ImmunoCAP) to fish parvalbumin (rCyp c 1) below 0.35 kUA/L
* Ongoing pollen Immunotherapy (SIT).
* Any clinical condition that contraindicates SIT (EAACI-guidelines).
* 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, immunological and endocrine disease.
* Ongoing treatment with betablockers or ACE-inhibitors.
* Impossibility for the patient to comply with the scheduled visits.
* Pregnancy or nursing.
* Uncontrolled asthma.
* Subject who have 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 during screening and treatments.

Primary outcomes:
measure: Safety in the form of number and severity of adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Specific IgE
timeFrame: 1 year
measure: IgG4
timeFrame: 1 year
measure: Skin Prick Test
timeFrame: 1 Year
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Allergy Clinic, Gentofte Hospital
Study officials:
affiliation: Allergy Clinic, Gentofte University Hospital
name: Hans-Joergen Malling, MD
role: PRINCIPAL_INVESTIGATOR
References: