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Cell Immunity Response to Vaccination Against Influenza in Patients With Rheumatoid Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01002716
First received: October 15, 2009
Last updated: October 26, 2009
Last verified: October 2009
History of Changes
  Purpose

The efficacy of vaccination against influenza in patients with rheumatoid arthritis has been assessed using humoral response. However, the cellular immunity is another important pathway of response to vaccination. The purpose of this study is to evaluate the degree of cellular immunity response to influenza vaccination. Patient with rheumatoid arthritis and healthy controls will participate in this study , will undergo a clinical evaluation the day of vaccination and 4 weeks after. The humoral and cell immunity response will be assessed the day of vaccination and 4 weeks later


Condition Intervention Phase
Rheumatoid Arthritis
 Biological: Agrippal S1 (Influenza vaccination)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cell Immunity Response to Vaccination Against Influenza in Patients With Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Cell immunity response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of influenza vaccination [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: October 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Agrippal S1 (Influenza vaccination)
    Single dose of vaccine
    Other Name: Agripal S1
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis

Exclusion Criteria:

  • Allergy to egg
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002716

Contacts
Contact: Ori Elkayam, MD 97236973668 orie@tasmc.health.gov.il

Locations
Israel
Tel Aviv Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Ayelet Brill     97236974837     ayeletb@tasmc.health.gov.il    
Sub-Investigator: Dan Caspi, M.D            
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

Additional Information:
Tel Aviv Medical Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Ori Elkayam, Tel Aviv Medical Center
ClinicalTrials.gov Identifier: NCT01002716     History of Changes
Other Study ID Numbers: TASMC-09-OE-0453-CTIL
Study First Received: October 15, 2009
Last Updated: October 26, 2009
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Tel-Aviv Sourasky Medical Center:
rheumatoid influenza vaccine cell immunity

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Influenza, Human
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013