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The Effect of Rituximab on the Humoral Response to Influenza Vaccine

This study has been terminated.
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00466037
First received: April 24, 2007
Last updated: April 25, 2007
Last verified: April 2007
  Purpose

Rituximab is a genetically engineered chimeric anti-CD20 monoclonal antibody that selectively targets CD20+ B cells and induces a transient depletion of the CD20+ mature B cell subpopulation.The objective of our study was to assess the effect of rituximab on the efficacy and safety of influenza virus vaccine in patients with rheumatoid arthritis (RA).


Condition Intervention
Rheumatoid Arthritis
Biological: Influenza vaccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Vaccination Against Influenza in Rheumatoid Arthritis Patients: The Effect of Rituximab on the Humoral Response

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Efficacy of vaccination against influenza

Secondary Outcome Measures:
  • Safety of vaccination against influenza in Rheumatoid Arthritis patients

Estimated Enrollment: 64
Study Start Date: September 2005
Estimated Study Completion Date: February 2006
Detailed Description:

The study population comprised RA patients treated with conventional disease modifying drugs with or without rituximab. Split-virion inactivated vaccine containing 15 mcg hemagglutinin/dose of B/Shanghai/361/02 (SHAN), A/New Caledonia A/New Caledonia/ 20/99 (NC) (H1N1) and A/California/7/04 (CAL) (H3N2) was used. Disease activity was assessed by number of tender and swollen joints, morning stiffness duration, and evaluation of pain on the day of vaccination and 4 weeks later. CD20 positive cell levels were assessed in rituximab treated patients. Hemagglutination inhibition (HI) antibodies were tested and response was defined as >4-fold rise 4 weeks post vaccination or seroconversion in patients with a non-protective baseline level of antibodies (<1/40). Geometric mean titers (GMT) were calculated in all subjects.

Results: The participants were divided into 3 groups: RA (n=29, aged 64±12 years), rituximab-treated RA (n=14, aged 53±15 years) and healthy controls (n=21, aged 58±15 years). All baseline protective levels of HI antibodies and GMT were similar. Four weeks after vaccination, there was a significant increase in GMT for NC and California antigens in all subjects, but not for the Shanghai antigen in the rituximab group. Similarly, the percentage of responders was low for Shanghai and NC, but significantly lowers in rituximab treated patients for the California antigen compared with the other groups. Parameters of disease activity remained unchanged.

Conclusion: Influenza virus vaccine generated a humoral response in all RA study patients and controls. Although the response was significantly lower among rituximab-treated patients,

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with Rheumatoid Arthritis
  • Age-18-85
  • Treatment with Rituximab and other Disease modifying drugs

Exclusion Criteria:

  • Treatment with anti TNF alpha
  • Allergy to eggs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466037

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Ori Elkayam, M.D Tel Aviv Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00466037     History of Changes
Other Study ID Numbers: TASMC-05-OE-204-CTIL
Study First Received: April 24, 2007
Last Updated: April 25, 2007
Health Authority: Israel:TASMC helsinki comittee

Keywords provided by Tel-Aviv Sourasky Medical Center:
Rheumatoid
rituximab
influenza

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014