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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01301703

Enrollment

100

Registered

2011-02-23

Start date

2011-03-31

Completion date

2012-02-29

Last updated

2011-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid pertussis tetanus

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.

Interventions

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

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Israel

Contacts

Primary ContactOri Elkayam, M.D

orie@tasmc.health.gov.il97236973668

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026