Vaccination Against Pertussis, Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01301703|
Recruitment Status : Unknown
Verified February 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was: Not yet recruiting
First Posted : February 23, 2011
Last Update Posted : February 23, 2011
Pertussis is an acute respiratory infection caused by Bordetella pertussis. Rates of recent B. pertussis infection between 8%--26% have been reported among adults with cough illness of at least 5 days duration who sought medical care. The CDC recommends vaccinating patients aged 15 to 64 years old, once in 10 years. Although acellular vaccines such as BOOSTRIX have been evaluated in healthy population, the safety and efficacy of this vaccine in patients suffering from rheumatic diseases have not been established.
Study population : 50 Rheumatoid Arthritis (RA) patients and 5 healthy controls
Evaluation : the evaluation will be performed on week 0 and 4-6 weeks later. In terms of safety, the patients will be evaluated according to the Disease Activity Index (DAS). Blood will be drawn at each visit at tested for humoral response to tetanus and pertussis.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy and Safety of Vaccination Against Pertussis. Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||February 2012|
Active Comparator: Tdap vaccination
Patients and controls will be vaccinated with BOOSTRIX (Tdap vaccine)
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)
a single 0.5-mL intramuscular injection into the deltoid muscle of the upper arm
- Immunogenicity of Tdap in patients suffering from rheumatoid arthritis [ Time Frame: 4-6 weeks after vaccination ]Geometric mean titers and individual responses to components of pertussis, tetanus and diphtheria
- Safety of Tdap vaccine in RA patients [ Time Frame: 4-6 weeks after vaccination ]Safety will be evaluated using the disease activity score (DAS) at baseline and 4-6 weeks later
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301703
|Contact: Ori Elkayam, M.Dfirstname.lastname@example.org|
|Department of Rheumatology, Tel Aviv Medical Center||Not yet recruiting|
|Tel Aviv, Israel, 64239|
|Contact: Ori Elkayam, M.D 97236973668 email@example.com|