The Effect of Rituximab on the Humoral Response to Influenza Vaccine

Not Applicable

Terminated

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00466037
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

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).

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,

Study Timeline

• Study Start: 2005-09
• Study Completion: 2006-02
• Status Verified: 2007-04
• Study First Submitted: 2007-04-24
• Study First Submitted QC: 2007-04-25
• Last Update Submitted: 2007-04-25
• Study First Posted: 2007-04-27
• Last Update Posted: 2007-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy of vaccination against influenza

Secondary Outcome Measures

Name	Time	Method
Safety of vaccination against influenza in Rheumatoid Arthritis patients