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

NCT01301703 | Unknown Phase 4 DMC

• 1 other identifier: 0068-09
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid pertussis tetanus

Outcome Measures

Primary Outcomes (1)

• Immunogenicity of Tdap in patients suffering from rheumatoid arthritis

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

  4-6 weeks after vaccination

Secondary Outcomes (1)

• Safety of Tdap vaccine in RA patients

  4-6 weeks after vaccination

Study Arms (1)

Tdap vaccination

ACTIVE COMPARATOR

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

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

Interventions

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

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

Tdap vaccination

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients suffering from RA
• Aged 18 to 64 years old

You may not qualify if:

• Active disease requiring a change in drug regimen
• Known allergy to vaccine

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Department of Rheumatology, Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Tetanus Toxoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

Ori Elkayam, M.D

CONTACT

97236973668; orie@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 21, 2011
• First Posted: February 23, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: February 23, 2011

Record last verified: 2010-02

Locations

IL (1)