The Effect of Rituximab on the Humoral Response to Influenza Vaccine
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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 |
- Efficacy of vaccination against influenza
- Safety of vaccination against influenza in Rheumatoid Arthritis patients
| Estimated Enrollment: | 64 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | February 2006 |
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 |
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
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 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 Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013