Antibody Response to Influenza Vaccine in Patients With Sarcoidosis

NCT ID: NCT00828828

Last Updated: 2009-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-05-31

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.

Conditions

Pulmonary Sarcoidosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Sarcoidosis

Sarcoidosis patients who are assigned to receive influenza vaccine

Influenza Vaccine

Intervention Type: BIOLOGICAL

One 0.5 ml dose of influenza vaccine injected intramuscular.

Healthy Controls

Healthy controls who are assigned to receive influenza vaccine

Influenza Vaccine

Intervention Type: BIOLOGICAL

One 0.5 ml dose of influenza vaccine injected intramuscular.

Interventions

Influenza Vaccine

One 0.5 ml dose of influenza vaccine injected intramuscular.

Intervention Type: BIOLOGICAL

Other Intervention Names

2008-2009 vaccination campaign of influenza (Solvay Pharma)

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Clinical Research & DevelopmentCenter, Shaheed Modarres Hospital, Shaheed Beheshti Medical University, Tehran, Iran.

Principal Investigators

Maryam Keshtkar-Jahromi, MD, MPH

Role: STUDY_CHAIR

Clinical Research & Development Center, Shahid Modarres Hospital, Shahid Beheshti University (MC), Tehran, Iran

Sasan Tavana, MD

Role: STUDY_CHAIR

Clinical Research & Developement Center, Shahid Modares Hospital,Shahid Beheshti University (MC), Tehran, Iran

Marzieh Keshtkar-Jahromi, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research & Developement Center, Shahid Modares Hospital, Shahid Beheshti University (MC), Tehran, Iran

Amirsoheil Talebian, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research & Developement Center, Shahid Modares Hospital,Shahid Beheshti University (MC), Tehran, Iran

Mohammad Rahnavardi, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research & Developement Center, Shahid Modares Hospital,Shahid Beheshti University (MC), Tehran, Iran

Talat Mokhtari-Azad, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Public Health, Tehran University of Medical Sciences, Tehran, Iran

Locations

Shahid Modarres Hospital

Tehran, , Iran

Countries

Iran

References

Newman LS, Rose CS, Maier LA. Sarcoidosis. N Engl J Med. 1997 Apr 24;336(17):1224-34. doi: 10.1056/NEJM199704243361706. No abstract available.

Reference Type: BACKGROUND

PMID: 9110911 (View on PubMed)

Muller-Quernheim J. Sarcoidosis: immunopathogenetic concepts and their clinical application. Eur Respir J. 1998 Sep;12(3):716-38. doi: 10.1183/09031936.98.12030716.

Reference Type: BACKGROUND

PMID: 9762805 (View on PubMed)

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. doi: 10.1159/000067471.

Reference Type: BACKGROUND

PMID: 11070460 (View on PubMed)

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. doi: 10.1080/02770900701539723.

Reference Type: BACKGROUND

PMID: 18097856 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18700566 (View on PubMed)

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. doi: 10.1016/j.jcf.2007.05.002. Epub 2007 Jul 5.

Reference Type: BACKGROUND

PMID: 17616444 (View on PubMed)

Other Identifiers

SBMU 87-01-120-6003

Identifier Type: -

Identifier Source: org_study_id