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

• Sponsor: Tel-Aviv Sourasky Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01301703
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Duration (Months): 11.1
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief Summary

Pertussis is an acute respiratory infection caused by Bordetella pertussis. Rates of recent

1. 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
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• 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: Mar 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2011
• Anticipated Study Completion Date: Feb 1, 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 [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 [4-6 weeks after vaccination]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Department of Rheumatology, Tel Aviv Medical Center	Tel Aviv		Israel	64239

Sponsors and Collaborators

• Tel-Aviv Sourasky Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01301703
• Other Study ID Numbers: 0068-09
• First Posted: Feb 23, 2011
• Last Update Posted: Feb 23, 2011
• Last Verified: Feb 1, 2010

• Keywords provided by , ,: rheumatoid pertussis tetanus
• Additional relevant MeSH terms: Whooping Cough; Tetanus; Diphtheria; Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Feb 23, 2011