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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tdap vaccination | Active Comparator | Patients and controls will be vaccinated with BOOSTRIX (Tdap vaccine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) | Biological | a single 0.5-mL intramuscular injection into the deltoid muscle of the upper arm |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of Tdap in patients suffering from rheumatoid arthritis | Geometric mean titers and individual responses to components of pertussis, tetanus and diphtheria | 4-6 weeks after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Tdap vaccine in RA patients | Safety will be evaluated using the disease activity score (DAS) at baseline and 4-6 weeks later | 4-6 weeks after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ori Elkayam, M.D | Contact | 97236973668 | orie@tasmc.health.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology, Tel Aviv Medical Center | Tel Aviv | 64239 | Israel |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |