Antibody Response to Influenza Vaccine in Patients With Sarcoidosis

Pulmonary Sarcoidosis Clinical Trial

— IVS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828828
• Other study ID #: SBMU 87-01-120-6003
• Status: Completed
• Phase: Phase 3
• First received: January 23, 2009
• Last updated: May 20, 2009
• Start date: December 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the efficacy of influenza vaccine (antibody response) in patients with sarcoidosis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pulmonary Sarcoidosis
• Sarcoidosis
• Sarcoidosis, Pulmonary

Intervention

Biological:
• Influenza Vaccine
One 0.5 ml dose of influenza vaccine injected intramuscular.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Modarres Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

Müller-Quernheim J. Sarcoidosis: immunopathogenetic concepts and their clinical application. Eur Respir J. 1998 Sep;12(3):716-38. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Protective Antibody (equal or more than 1:40) titer after vaccination		4-6 weeks	No
Secondary	Vaccine Safety (any major or minor side effects)		2 months	Yes