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

Primary Purpose

Rheumatoid Arthritis

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)

About this trial

This is an interventional prevention trial for Rheumatoid Arthritis focused on measuring rheumatoid pertussis tetanus

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Rheumatology, Tel Aviv Medical Center

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Tdap vaccination

Arm Description

Patients and controls will be vaccinated with BOOSTRIX (Tdap vaccine)

Outcomes

Primary Outcome Measures

Immunogenicity of Tdap in patients suffering from rheumatoid arthritis

Geometric mean titers and individual responses to components of pertussis, tetanus and diphtheria

Secondary Outcome Measures

Safety of Tdap vaccine in RA patients

Safety will be evaluated using the disease activity score (DAS) at baseline and 4-6 weeks later

Full Information

NCT ID

NCT01301703

First Posted

February 21, 2011

Last Updated

February 22, 2011

Sponsor

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01301703

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Unknown status

Study Start Date

March 2011 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

February 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

rheumatoid pertussis tetanus

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tdap vaccination

Arm Type

Active Comparator

Arm Description

Patients and controls will be vaccinated with BOOSTRIX (Tdap vaccine)

Intervention Type

Biological

Intervention Name(s)

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)

Intervention Description

a single 0.5-mL intramuscular injection into the deltoid muscle of the upper arm

Primary Outcome Measure Information:

Title

Immunogenicity of Tdap in patients suffering from rheumatoid arthritis

Description

Geometric mean titers and individual responses to components of pertussis, tetanus and diphtheria

Time Frame

4-6 weeks after vaccination

Secondary Outcome Measure Information:

Title

Safety of Tdap vaccine in RA patients

Description

Safety will be evaluated using the disease activity score (DAS) at baseline and 4-6 weeks later

Time Frame

4-6 weeks after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ori Elkayam, M.D

Phone

97236973668

orie@tasmc.health.gov.il

Facility Information:

Facility Name

Department of Rheumatology, Tel Aviv Medical Center

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ori Elkayam, M.D

Phone

97236973668

orie@tasmc.health.gov.il

12. IPD Sharing Statement

Learn more about this trial

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

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