The Effect of Rituximab on the Humoral Response to Influenza Vaccine

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00466037

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Biological: Influenza vaccine	N/A

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Vaccination Against Influenza in Rheumatoid Arthritis Patients: The Effect of Rituximab on the Humoral Response

Study Start Date :

Sep 1, 2005

Study Completion Date :

Feb 1, 2006

Outcome Measures

Primary Outcome Measures

Efficacy of vaccination against influenza []

Secondary Outcome Measures

Safety of vaccination against influenza in Rheumatoid Arthritis patients []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

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

Locations

No locations specified.

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

Principal Investigator: Ori Elkayam, M.D, Tel Aviv Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00466037

Other Study ID Numbers:

TASMC-05-OE-204-CTIL

First Posted:

Apr 27, 2007

Last Update Posted:

Apr 27, 2007

Last Verified:

Apr 1, 2007

Keywords provided by , ,

Rheumatoid

rituximab

influenza

Additional relevant MeSH terms:

Influenza, Human

Arthritis

Arthritis, Rheumatoid

Study Results

No Results Posted as of Apr 27, 2007