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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)

Study type: Interventional

Funder types: Other

Identifiers

NCT01301703

0068-09

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Tdap vaccination

Active Comparator group

Description:

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

Treatment:

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