IVS: Antibody Response to Influenza Vaccine in Patients With Sarcoidosis
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the efficacy of influenza vaccine (antibody response) in patients with sarcoidosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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:
|
| 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:
|
Outcome Measures
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 [4-6 weeks]
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] [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
Sarcoidosis patients:
-
Patients with relevant clinical, radiologic and histologic features of sarcoidosis (all stages).
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Signed informed consent.
Exclusion Criteria:
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Organ failure (kidney, heart, liver).
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Collagen vascular diseases.
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Diabetes.
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Contraindications of vaccine (Egg allergy).
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Patients who receive high dose (> 60 mg/day) steroid therapy.
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Any acute disease.
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Conditions accompanied by immunosuppression (like organ transplantation, HIV).
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Any psychological disease that interferes with regular follow-up.
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Inoculation with influenza vaccine within the past 5 years.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shahid Modarres Hospital | Tehran | Iran, Islamic Republic of | 1998734383 |
Sponsors and Collaborators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- Müller-Quernheim J. Sarcoidosis: immunopathogenetic concepts and their clinical application. Eur Respir J. 1998 Sep;12(3):716-38. Review.
- Newman LS, Rose CS, Maier LA. Sarcoidosis. N Engl J Med. 1997 Apr 24;336(17):1224-34. Review. Erratum in: N Engl J Med 1997 Jul 10;337(2):139.
- 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. Epub 2007 Jul 5.
- SBMU 87-01-120-6003