Clinical Trial: Antibody Response to Influenza Vaccine in Patients With Sarcoidosis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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

Detailed Summary:

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.


Sponsor: Shahid Beheshti University of Medical Sciences

Current Primary Outcome: 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 [ Time Frame: 4-6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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] [ Time Frame: 4-6 weeks ]
  • Protective Antibody (equal or more than 1:40) titer after vaccination [ Time Frame: 4-6 weeks ]
  • Vaccine Safety (any major or minor side effects) [ Time Frame: 2 months ]


Original Secondary Outcome: Same as current

Information By: Shahid Beheshti University of Medical Sciences

Dates:
Date Received: January 23, 2009
Date Started: December 2008
Date Completion:
Last Updated: May 20, 2009
Last Verified: May 2009