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

Phase 1

Completed

• Conditions: Fish Allergy
• Interventions: Biological: mCyp c 1

• Registration Number: NCT02017626
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2013-12-16
• Study First Posted: 2013-12-23
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-18
• Last Update Posted: 2015-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	mCyp c 1	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.
group 1	mCyp c 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

Primary Outcome Measures

Name	Time	Method
Safety in the form of number and severity of adverse events	1 year	Safety is evaluated by number and severity of adverse events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Allergy Clinic, Gentofte Hospital; 🇩🇰 Hellerup, Denmark