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

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ClinicalTrials.gov Identifier: NCT00828828
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : May 21, 2009
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Tracking Information
First Submitted Date January 23, 2009
First Posted Date January 26, 2009
Last Update Posted Date May 21, 2009
Study Start Date December 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 23, 2009)
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 Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 23, 2009)
  • 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 Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Antibody Response to Influenza Vaccine in Patients With Sarcoidosis
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 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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Pulmonary Sarcoidosis
Intervention Biological: Influenza Vaccine
One 0.5 ml dose of influenza vaccine injected intramuscular.
Other Name: 2008-2009 vaccination campaign of influenza (Solvay Pharma)
Study Groups/Cohorts
  • Sarcoidosis
    Sarcoidosis patients who are assigned to receive influenza vaccine
    Intervention: Biological: Influenza Vaccine
  • Healthy Controls
    Healthy controls who are assigned to receive influenza vaccine
    Intervention: Biological: Influenza Vaccine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 20, 2009)
49
Original Estimated Enrollment
 (submitted: January 23, 2009)
50
Actual Study Completion Date May 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT00828828
Other Study ID Numbers SBMU 87-01-120-6003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Maryam Keshtkar-Jahromi, Clinical Research & DevelopmentCenter, Shaheed Modarres Hospital, Shaheed Beheshti Medical University, Tehran, Iran.
Study Sponsor Shahid Beheshti University of Medical Sciences
Collaborators Not Provided
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
PRS Account Shahid Beheshti University of Medical Sciences
Verification Date May 2009