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

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00828828
First received: January 23, 2009
Last updated: May 20, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Pulmonary Sarcoidosis
Biological: Influenza Vaccine
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Controlled Trial of Serologic Efficacy of Influenza Vaccine in Patients With Sarcoidosis

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Protective Antibody (equal or more than 1:40) titer after vaccination [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
  • Vaccine Safety (any major or minor side effects) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: December 2008
Study Completion Date: May 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Sarcoidosis
Sarcoidosis patients who are assigned to receive influenza vaccine
Biological: Influenza Vaccine
One 0.5 ml dose of influenza vaccine injected intramuscular.
Other Name: 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 Name: 2008-2009 vaccination campaign of influenza (Solvay Pharma)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828828

Locations
Iran, Islamic Republic of
Shahid Modarres Hospital
Tehran, Iran, Islamic Republic of, 1998734383
Sponsors and Collaborators
Shahid Beheshti Medical University
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
  More Information

Publications:
Responsible Party: Maryam Keshtkar-Jahromi, Clinical Research & DevelopmentCenter, Shaheed Modarres Hospital, Shaheed Beheshti Medical University, Tehran, Iran.
ClinicalTrials.gov Identifier: NCT00828828     History of Changes
Other Study ID Numbers: SBMU 87-01-120-6003
Study First Received: January 23, 2009
Last Updated: May 20, 2009
Health Authority: Iran: Ministry of Health

Keywords provided by Shahid Beheshti Medical University:
Influenza Vaccine
Sarcoidosis
Antibody

Additional relevant MeSH terms:
Influenza, Human
Sarcoidosis
Sarcoidosis, Pulmonary
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases

ClinicalTrials.gov processed this record on April 22, 2014