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

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ClinicalTrials.gov Identifier: NCT01002716
Recruitment Status : Unknown
Verified October 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : October 27, 2009
Last Update Posted : October 27, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Agrippal S1 (Influenza vaccination) Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cell Immunity Response to Vaccination Against Influenza in Patients With Rheumatoid Arthritis
Study Start Date : October 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Biological: Agrippal S1 (Influenza vaccination)
    Single dose of vaccine
    Other Name: Agripal S1

Outcome Measures

Primary Outcome Measures :
  1. Cell immunity response [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Safety of influenza vaccination [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis

Exclusion Criteria:

  • Allergy to egg
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Ori Elkayam, Tel Aviv Medical Center
ClinicalTrials.gov Identifier: NCT01002716     History of Changes
Other Study ID Numbers: TASMC-09-OE-0453-CTIL
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: October 27, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Arthritis
Influenza, Human
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs