FAST-Fish -Food Allergy Specific Treatment for Fish Allergy.

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.

Study Overview

• Status: Completed
• Conditions: Fish Allergy
• Intervention / Treatment: Biological: mCyp c 1

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Allergy clinic, Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1; 5 patients will receive 10 single rising doses of mCyp c 1 (modified allergen)from 0.6 ng to 6 ug and two maintenance doses, and 2 patients will receive placebo	Biological: mCyp c 1; 2 patient groups with different doses of allergen.; Other Names: A modified hypo-allergenic Parvalbumin
Experimental: Group 2; 6 patients will receive 10 single rising doses of mCyp c 1 from 6 ng to 60 ug and two maintenance doses, and two patients will receive placebo.	Biological: mCyp c 1; 2 patient groups with different doses of allergen.; Other Names: A modified hypo-allergenic Parvalbumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety in the form of number and severity of adverse events	Safety is evaluated by number and severity of adverse events	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific IgE	To study the pharmaco-dynamics of the hypo-allergen administered to human subjects i.e. Specific IgE.	1 year
IgG4	Immunologic parameter.	1 year
Skin Prick Test	Pharmaco-dynamics of the hypo-allergen administered to human subjects.	1 Year

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Odense University Hospital; University Hospital, Gentofte, Copenhagen
• Investigators: Principal Investigator: Hans-Joergen Malling, MD, Allergy Clinic, Gentofte University Hospital

Publications and helpful links

Helpful Links

• FAST: Towards safe and effective subcutaneous immunotherapy of persistent life-threatening food allergies.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: August 21, 2013
• First Submitted That Met QC Criteria: December 16, 2013
• First Posted (Estimate): December 23, 2013

Study Record Updates

• Last Update Posted (Estimate): June 19, 2015
• Last Update Submitted That Met QC Criteria: June 18, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: immunotherapy; Fish allergy; hypoallergen
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: K-489 DK