Antibody Response to Influenza Vaccine in Patients With Sarcoidosis

Completed

• Conditions: Pulmonary Sarcoidosis
• Interventions: Biological: Influenza Vaccine

• Registration Number: NCT00828828
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-23
• Study First Submitted QC: 2009-01-23
• Study First Posted: 2009-01-26
• Primary Completion: 2009-02
• Status Verified: 2009-05
• Study Completion: 2009-05
• Last Update Submitted: 2009-05-20
• Last Update Posted: 2009-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sarcoidosis	Influenza Vaccine	Sarcoidosis patients who are assigned to receive influenza vaccine
Healthy Controls	Influenza Vaccine	Healthy controls who are assigned to receive influenza vaccine

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Shahid Modarres Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of