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Completed

NCT Number: NCT00828828

Antibody Response to 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

influenza vaccine

Biological

One 0.5 ml dose of influenza vaccine injected intramuscular.

Other names: 2008-2009 vaccination campaign of influenza (Solvay Pharma)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Protective Antibody (equal or more than 1:40) titer after vaccination

    Time frame: 4-6 weeks

  3. Vaccine Safety (any major or minor side effects)

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

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

Acronym: IVS

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 26, 2009
Registry last updated
May 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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