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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

January 23, 2009
May 20, 2009
December 2008
February 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00828828 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Antibody Response to Influenza Vaccine in Patients With Sarcoidosis
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Pulmonary Sarcoidosis
Biological: Influenza Vaccine
One 0.5 ml dose of influenza vaccine injected intramuscular.
Other Name: 2008-2009 vaccination campaign of influenza (Solvay Pharma)
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
May 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
20 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00828828
SBMU 87-01-120-6003
Yes
Maryam Keshtkar-Jahromi, Clinical Research & DevelopmentCenter, Shaheed Modarres Hospital, Shaheed Beheshti Medical University, Tehran, Iran.
Shahid Beheshti Medical University
Not Provided
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
Shahid Beheshti Medical University
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP