Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466037
Status:
TERMINATED
Last Update Posted:
2007-04-27
First Post:
2007-04-24
Brief Title:
The Effect of Rituximab on the Humoral Response to Influenza Vaccine
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
Vaccination Against Influenza in Rheumatoid Arthritis Patients The Effect of Rituximab on the Humoral Response
Status:
TERMINATED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subpopulationThe 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 hemagglutinindose of BShanghai36102 SHAN ANew Caledonia ANew Caledonia 2099 NC H1N1 and ACalifornia704 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 140 Geometric mean titers GMT were calculated in all subjects
Results The participants were divided into 3 groups RA n29 aged 6412 years rituximab-treated RA n14 aged 5315 years and healthy controls n21 aged 5815 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
Results The participants were divided into 3 groups RA n29 aged 6412 years rituximab-treated RA n14 aged 5315 years and healthy controls n21 aged 5815 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None