IDA (Immunothérapie de la Dermatite Atopique) Adult - Immunotherapy in Atopic Dermatitis

Study Overview
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Brief Summary
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Atopic dermatitis (AD) is a chronic inflammatory disease of the skin. AD is very frequent, and involves T lymphocytes cells. Measles vaccination, as well as measles vaccine, induces a temporary immunosuppression; furthermore, an improvement of AD has been observed during measles infection. This trial is aimed at demonstrating that measles vaccine is able to create an immunomodulation and to improve AD symptoms. 30 adult patients of both sexes with moderate to severe AD will be randomly assigned to measles vaccine (ROUVAX ®), or placebo (vehicle) and follow-up for 45 days. The primary outcome is the effect of anti-measles vaccination on the T cell responses in patients; Other outcomes include: clinical evolution of AD, as measured by the SCORAD, the evolution of blood level of measles specific IgE and antibodies; evolution of other biomarkers and phenotypic characteristics of T lymphocytes.

Detailed Description
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Atopic dermatitis (AD) is a chronic inflammatory disease of the skin. AD is very frequent, and involves T lymphocytes cells. Measles vaccination, as well as measles vaccine, induces a temporary immunosuppression; furthermore, an improvement of AD has been observed during measles infection. This trial is aimed at demonstrating that measles vaccine is able to create an immunomodulation and to improve AD symptoms.

Official Title
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Immunotherapy of Atopic Dermatitis in Adult Patients by Anti-measles Vaccination IDA (Immunothérapie de la Dermatite Atopique)Protocol

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Biological: ROUVAX
* Biological: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults patients of both sexes, with moderate to severe Atopic Dermatitis (SCORAD (Score for Atopic Dermatitis) ≥ 15). Exclusion Criteria: hypersensititvity or contra-indication to a Rouvax® component, Tubertest® component, to egg proteins, immunological deficiency, pregnancy, neomycin allergy, systemic immnosuppressive treatment in the previous 3 months, topic immunosuppressive treatment during the week preceeding the inclusion (gluco-corticoid, or immunosuppressive agent), fever or acute disease (the inclusion must be postpone in such cases).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rouvax<br> | Biological: ROUVAX<br>* Measles vaccine (ROUVAX ®), Schwarz strain (>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection.<br>|
| Placebo Comparator: Placebo<br>Sub cutaneous injection of vehicle | Biological: placebo<br>* Vehicle (water for injection), 0.5 ml, once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of anti-measles vaccination on the T cell responses in patients |  | 7 / 10 days after vaccine / placebo injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evolution of AD, as measured by the SCORAD |  | 3 weeks after injection | 
| blood level of measles specific IgE and antibodies |  | 3 weeks after injection | 
| Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18 |  | 7 days, 14 days, 3 weeks after injection | 
| phenotypic characteristics of T lymphocytes |  | 7 days, 14 days, 3 weeks, and 6 weeks after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, immunosuppression, Measles vaccine, T lymphocytes, Atopic Dermatitis in adults