The Safety and Immunogenicity of Acellular Pertussis Vaccine in Bone Marrow Transplant Recipients

This study is enrolling participants by invitation only.

Sponsored by:	Queen Elizabeth II Health Sciences Centre
Information provided by:	Queen Elizabeth II Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00336115

Purpose

The purpose of this study is to determine if pertussis (whooping cough) vaccine is safe and produces an appropriate immune response against pertussis in blood and marrow transplant patients.

Condition	Intervention	Phase
Pertussis	Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)	Phase IV

MedlinePlus related topics: Bone Marrow Transplantation Diphtheria Tetanus Whooping Cough

Drug Information available for: Diphtheria-Pertussis-Tetanus Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Safety and Immunogenicity of Adult Formulation Tetanus and Diphtheria Toxoids Adsorbed Combined With Acellular Pertussis (Tdap) Vaccine Following Blood and Morrow Transplantation in Adults

Further study details as provided by Queen Elizabeth II Health Sciences Centre:

Primary Outcome Measures:

Safety of the vaccine [ Time Frame: 28 days post-dose ]

Secondary Outcome Measures:

Immunogenicity of vaccine [ Time Frame: 60 days post-dose ]

Estimated Enrollment:	10
Study Start Date:	July 2006
Estimated Study Completion Date:	May 2008

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Aged 18-64
BMT at the QEII Health Sciences Centre
BMT within last 12 months
Able to read and write English language
Able to give consent

Exclusion Criteria:

Active infection
Active GVHD
Recent IVIG
Allergy to components of vaccine
Diphtheria or tetanus vaccination within 18 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336115

Sponsors and Collaborators

Queen Elizabeth II Health Sciences Centre

Investigators

Principal Investigator:	Monique L MacFarlane Conrad, MSc	Dalhousie University Medical School
Study Director:	Shelly McNeil, MD	QEII Health Sciences Centre

More Information

Study ID Numbers:	qeii
Study First Received:	June 9, 2006
Last Updated:	October 22, 2007
ClinicalTrials.gov Identifier:	NCT00336115
Health Authority:	Canada: Health Canada

Keywords provided by Queen Elizabeth II Health Sciences Centre:

pertussis
bone marrow transplant

Study placed in the following topic categories:

Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Cough
Whooping Cough

Diphtheria
Tetanus
Whooping cough
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Bordetella Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009