Antibody Response to Influenza Vaccine in Patients With Sarcoidosis (IVS)

Shahid Beheshti University of Medical Sciences

Status: Completed

Conditions: Pulmonary Sarcoidosis

Treatments: Biological: Influenza Vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT00828828

SBMU 87-01-120-6003

Details and patient eligibility

About

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

Full description

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.

Enrollment: 49 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

49 participants in 2 patient groups

Sarcoidosis

Description:

Sarcoidosis patients who are assigned to receive influenza vaccine

Treatment:

Biological: Influenza Vaccine

Healthy Controls

Description:

Healthy controls who are assigned to receive influenza vaccine

Treatment:

Biological: Influenza Vaccine