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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01301703
Other study ID # 0068-09
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received February 21, 2011
Last updated February 22, 2011
Start date March 2011
Est. completion date February 2012

Study information

Verified date February 2010
Source Tel-Aviv Sourasky Medical Center
Contact Ori Elkayam, M.D
Phone 97236973668
Email orie@tasmc.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date February 2012
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- Patients suffering from RA

- Aged 18 to 64 years old

Exclusion Criteria:

- Active disease requiring a change in drug regimen

- Known allergy to vaccine

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel Department of Rheumatology, Tel Aviv Medical Center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 Yes
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