Immune Responses in Hen's Egg Oral Immunotherapy

Helsinki University Central Hospital (HUCH)

Status: Unknown

Conditions: Food Allergy; Egg Protein Allergy; Immune Tolerance

Treatments: Dietary Supplement: Hen's egg OIT

Study type: Interventional

Funder types: Other

Identifiers

NCT03744325

HOIT01

Details and patient eligibility

About

The study determines how a 6 months oral immunotherapy (OIT) program with hen's egg (HE) effects cellular and humoral immune responses in 50 children with HE allergy. Clinical data, transcriptomics and epigenetics are combined and analyzed by advanced system biology methods. This study will provide better understanding of the effects and mechanisms of OIT.

Full description

Oral immunotherapy (OIT) is a therapeutic approach, where gradually increasing doses of a specific food allergen are administered orally. OIT can desensitize up to 80% of children with persistent food allergy, and in a subset lead to sustained immune tolerance. The immunologic mechanisms induced by OIT are still poorly understood.

In this randomized cross-over study, 50 children with challenge-confirmed hen's egg (HE) allergy will be randomized (2:1) to receive either active HE OIT or continue on an avoidance diet for 6 months after which active OIT is started. The immunological changes induced by OIT will be compared to the patient's initial status and to that of the patients on an avoidance diet.

Serum antibody and humoral mediator analyses as well as gene expression of blood mononuclear cell (PBMC) by genome-wide microarray assays will be studied. PBMCs will be stimulated with HE allergens and innate immunity agonists, and the differences in the expression profiles of messenger-RNAs as well as microRNAs will be studied. Single-cell sequencing and sorting of regulator T cells (Tregs) will be performed focusing on their transcriptomic responses and gene methylation. Finally, clinical data, transcriptomics and epigenetic changes will be combined and analyzed by advanced system biology methods.

This study will provide better understanding of the effects and mechanisms of OIT and identify biomarkers for selection of patients benefitting from personalized OIT.

Enrollment: 50 patients

Sex: All

Ages: 6 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 6-19 years
2. Sensitization to egg white (egg white- specific IgE ≥0.35 kU/l or skin prick test ≥3 mm)
3. Positive double-blind, placebo-controlled food challenge to heated egg white

Exclusion criteria

1. Poor adherence
2. Uncontrolled or severe asthma
3. Severe systemic illness
4. Active autoimmune disease
5. Active, malignant neoplasia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Hen's egg OIT

Active Comparator group

Description:

Daily intake of gradually increasing doses of egg white protein under a 32 weeks period, continued by regular, daily intake of 1000 mg egg white protein.

Treatment:

Dietary Supplement: Hen's egg OIT

Hen's egg avoidance

No Intervention group

Description:

Hen's egg is avoidance diet is continued.