Vaccination Against Pertussis, Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis

February 22, 2011 updated by: Tel-Aviv Sourasky Medical Center

The Efficacy and Safety of Vaccination Against Pertussis. Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Department of Rheumatology, Tel Aviv Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4-6 weeks after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4-6 weeks after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2011

Study Completion (ANTICIPATED)

February 1, 2012

Study Registration Dates

First Submitted

February 21, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (ESTIMATE)

February 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0068-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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