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

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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Sarcoidosis
• Intervention / Treatment: Biological: Influenza Vaccine

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 Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1998734383
    • Shahid Modarres Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Caes are defined as patients known as sarcoidosis and are under follow up at a tertiary care hospital clinic. Age and sex matched healthy healthcare workers serve as controls.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sarcoidosis; Sarcoidosis patients who are assigned to receive influenza vaccine	Biological: Influenza Vaccine; One 0.5 ml dose of influenza vaccine injected intramuscular.; Other Names: 2008-2009 vaccination campaign of influenza (Solvay Pharma)
Healthy Controls; Healthy controls who are assigned to receive influenza vaccine	Biological: Influenza Vaccine; One 0.5 ml dose of influenza vaccine injected intramuscular.; Other Names: 2008-2009 vaccination campaign of influenza (Solvay Pharma)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences
• Investigators: Study Chair: Maryam Keshtkar-Jahromi, MD, MPH, Clinical Research & Development Center, Shahid Modarres Hospital, Shahid Beheshti University (MC), Tehran, Iran; Study Chair: Sasan Tavana, MD, Clinical Research & Developement Center, Shahid Modares Hospital,Shahid Beheshti University (MC), Tehran, Iran; Principal Investigator: Marzieh Keshtkar-Jahromi, MD, Clinical Research & Developement Center, Shahid Modares Hospital, Shahid Beheshti University (MC), Tehran, Iran; Principal Investigator: Amirsoheil Talebian, MD, Clinical Research & Developement Center, Shahid Modares Hospital,Shahid Beheshti University (MC), Tehran, Iran; Principal Investigator: Mohammad Rahnavardi, MD, Clinical Research & Developement Center, Shahid Modares Hospital,Shahid Beheshti University (MC), Tehran, Iran; Principal Investigator: Talat Mokhtari-Azad, PhD, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran

Publications and helpful links

General Publications

• Newman LS, Rose CS, Maier LA. Sarcoidosis. N Engl J Med. 1997 Apr 24;336(17):1224-34. doi: 10.1056/NEJM199704243361706. No abstract available. Erratum In: N Engl J Med 1997 Jul 10;337(2):139.
• Mert A, Bilir M, Ozaras R, Tabak F, Karayel T, Senturk H. Results of hepatitis B vaccination in sarcoidosis. Respiration. 2000;67(5):543-5. doi: 10.1159/000067471.
• Muller-Quernheim J. Sarcoidosis: immunopathogenetic concepts and their clinical application. Eur Respir J. 1998 Sep;12(3):716-38. doi: 10.1183/09031936.98.12030716.
• Kmiecik T, Arnoux S, Kobryn A, Gorski P. Influenza vaccination in adults with asthma: safety of an inactivated trivalent influenza vaccine. J Asthma. 2007 Dec;44(10):817-22. doi: 10.1080/02770900701539723.
• Ayabe E, Kaneko N, Ohkuni Y, Misawa M, Inoue K, Tanabe Y, Yasui D, Sato C, Mitsuishi Y, Nakashita T, Motojima S. [The efficacy of influenza vaccine for acute exacerbation of chronic obstructive lung disease in elderly patients]. Nihon Kokyuki Gakkai Zasshi. 2008 Jul;46(7):511-5. Japanese.
• Wat D, Gelder C, Hibbitts S, Bowler I, Pierrepoint M, Evans R, Doull I. Is there a role for influenza vaccination in cystic fibrosis? J Cyst Fibros. 2008 Jan;7(1):85-8. doi: 10.1016/j.jcf.2007.05.002. Epub 2007 Jul 5.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: January 23, 2009
• First Submitted That Met QC Criteria: January 23, 2009
• First Posted (Estimate): January 26, 2009

Study Record Updates

• Last Update Posted (Estimate): May 21, 2009
• Last Update Submitted That Met QC Criteria: May 20, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Antibody; Sarcoidosis; Influenza Vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Lung Diseases; Orthomyxoviridae Infections; Lung Diseases, Interstitial; Influenza, Human; Sarcoidosis, Pulmonary; Sarcoidosis
• Other Study ID Numbers: SBMU 87-01-120-6003