Antibody Response to Influenza Vaccine in Patients With Sarcoidosis

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of influenza vaccine (antibody response) in patients with sarcoidosis.

Detailed Description
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Sarcoidosis is a multisystem disease with unclear etiology characterized by the presence of noncaseating granuloma[1]. T helper cells response is exaggerated at the site of disease and cellular immunity depressed in peripheral blood[2]. Cutaneous anergy, lymphopenia and inversion of CD4/CD8 ratio in peripheral blood suggest T helper cells involvement[3]. The action of humeral immune system in sarcoidosis is a matter of controversy. Standard hepatitis B virus vaccination did not provoke protective antibody titer in patients with sarcoidosis[3]. Although antibody response against influenza vaccine in patients with sarcoidosis is not well described, this vaccine is highly recommended in patients with chronic pulmonary diseases such as asthma, COPD and fibrosis [4, 5, 6]. In this study we aim to evaluate the humeral response to the influenza vaccine in sarcoidosis patients and assess vaccine safety.

Official Title
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Controlled Trial of Serologic Efficacy of Influenza Vaccine in Patients With Sarcoidosis

Conditions
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Pulmonary Sarcoidosis

Intervention / Treatment
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* Biological: Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sarcoidosis patients: Patients with relevant clinical, radiologic and histologic features of sarcoidosis (all stages). Signed informed consent. Exclusion Criteria: Organ failure (kidney, heart, liver). Collagen vascular diseases. Diabetes. Contraindications of vaccine (Egg allergy). Patients who receive high dose (> 60 mg/day) steroid therapy. Any acute disease. Conditions accompanied by immunosuppression (like organ transplantation, HIV). Any psychological disease that interferes with regular follow-up. Inoculation with influenza vaccine within the past 5 years.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sarcoidosis<br>Sarcoidosis patients who are assigned to receive influenza vaccine | Biological: Influenza Vaccine<br>* One 0.5 ml dose of influenza vaccine injected intramuscular.<br>* Other names: 2008-2009 vaccination campaign of influenza (Solvay Pharma);|
| Healthy Controls<br>Healthy controls who are assigned to receive influenza vaccine | Biological: Influenza Vaccine<br>* One 0.5 ml dose of influenza vaccine injected intramuscular.<br>* Other names: 2008-2009 vaccination campaign of influenza (Solvay Pharma);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serologic Response (equal or more than 4 fold HI titer rise) to each of the 3 antigens of the trivalent vaccine of the 2008-9 influenza vaccine |  | 4-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnitude of change in the antibody titer against each of the 3 antigenes of the trivalent vaccine of the 2008/2009 season [A/Brisbane/59/2007(HIN1)-like virus;A/Brisbane/10/2007(H3N2)-like virus;B/Florida/4/2006-like virus] |  | 4-6 weeks | 
| Protective Antibody (equal or more than 1:40) titer after vaccination |  | 4-6 weeks | 
| Vaccine Safety (any major or minor side effects) |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza Vaccine, Sarcoidosis, Antibody