Clinical trial NCT00828828: Antibody Response to Influenza Vaccine in Patients With Sarcoidosis
Official title: Controlled Trial of Serologic Efficacy of Influenza Vaccine in Patients With Sarcoidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Sarcoidosis
Keywords: Influenza Vaccine
Sarcoidosis
Antibody
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-01-26
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
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
timeFrame: 4-6 weeks
Secondary outcomes:
measure: 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]
timeFrame: 4-6 weeks
measure: Protective Antibody (equal or more than 1:40) titer after vaccination
timeFrame: 4-6 weeks
measure: Vaccine Safety (any major or minor side effects)
timeFrame: 2 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Modarres Hospital
Study officials:
affiliation: Clinical Research & Development Center, Shahid Modarres Hospital, Shahid Beheshti University (MC), Tehran, Iran
name: Maryam Keshtkar-Jahromi, MD, MPH
role: STUDY_CHAIR
affiliation: Clinical Research & Developement Center, Shahid Modares Hospital,Shahid Beheshti University (MC), Tehran, Iran
name: Sasan Tavana, MD
role: STUDY_CHAIR
affiliation: Clinical Research & Developement Center, Shahid Modares Hospital, Shahid Beheshti University (MC), Tehran, Iran
name: Marzieh Keshtkar-Jahromi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research & Developement Center, Shahid Modares Hospital,Shahid Beheshti University (MC), Tehran, Iran
name: Amirsoheil Talebian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research & Developement Center, Shahid Modares Hospital,Shahid Beheshti University (MC), Tehran, Iran
name: Mohammad Rahnavardi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
name: Talat Mokhtari-Azad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. doi: 10.1159/000067471.
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. doi: 10.1080/02770900701539723.
citation: 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.
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. doi: 10.1016/j.jcf.2007.05.002. Epub 2007 Jul 5.