Antibody Response to Influenza Vaccine in Patients With Sarcoidosis

NCT00828828 | Completed DMC

• 1 other identifier: SBMU 87-01-120-6003
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Sarcoidosis

Keywords

Influenza Vaccine; Sarcoidosis; Antibody

Outcome Measures

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

  4-6 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

Sarcoidosis

Sarcoidosis patients who are assigned to receive influenza vaccine

Biological: Influenza Vaccine

Healthy Controls

Healthy controls who are assigned to receive influenza vaccine

Biological: Influenza Vaccine

Interventions

Influenza Vaccine BIOLOGICAL

One 0.5 ml dose of influenza vaccine injected intramuscular.

Also known as: 2008-2009 vaccination campaign of influenza (Solvay Pharma)

Healthy Controls; Sarcoidosis

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Sarcoidosis patients:
• Patients with relevant clinical, radiologic and histologic features of sarcoidosis (all stages).
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Shahid Modarres Hospital

Tehran, 1998734383, Iran

Location

Related Publications (6)

• 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.

  PMID: 9110911 BACKGROUND

• 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.

  PMID: 9762805 BACKGROUND

• 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.

  PMID: 11070460 BACKGROUND

• 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.

  PMID: 18097856 BACKGROUND

• 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.

  PMID: 18700566 BACKGROUND

• 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.

  PMID: 17616444 BACKGROUND

MeSH Terms

Conditions

Sarcoidosis, Pulmonary; Influenza, Human; Sarcoidosis

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• 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

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 23, 2009
• First Posted: January 26, 2009
• Study Start: December 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 21, 2009

Record last verified: 2009-05

Locations

IR (1)