We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

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.D 97236973668 orie@tasmc.health.gov.il

Department of Rheumatology, Tel Aviv Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Ori Elkayam, M.D    97236973668    orie@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
More Information

Responsible Party: Prof Ori Elkayam, Department of Rheumatology. Tel Aviv Medical Center
ClinicalTrials.gov Identifier: NCT01301703     History of Changes
Other Study ID Numbers: 0068-09
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: February 2010

Keywords provided by Tel-Aviv Sourasky Medical Center:
rheumatoid pertussis tetanus

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Whooping Cough
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Immunologic Factors
Physiological Effects of Drugs