FAST-Fish - Food allergy vaccination for fish allergy

Phase 1

• Conditions: Fish Allergy; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-005173-32-DK
• Lead Sponsor: FAST-consortium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-09
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Allergy towards fish, 18-65 years, Case history of alleryg 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 at screening, Positive DBPCFC with fish within the last two years, FEV1 at least 80 % of predited 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 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Food anaphylactic shock due to fish intake, Specific IgE to fish parvalbumin below 0.35 kUA/L, ongoing pollen IT, Any clinical conition that contraindicates IT, Any significant clinical condition that might hamper the patients safety or the study outcome. Ongoing treatment with betablockers or ACE-inhibitors, Pregnancy or ursing.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified