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

• Sponsor: Queen Elizabeth II Health Sciences Centre (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00336115
• Collaborator: (none)
• Enrollment: 10
• Duration (Months): 22

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Pertussis	Biological: Tetanus and Diphtheria Toxoids Adsorbed Combined with Acellular Pertussis (Adacel)	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Study Start Date: Jul 1, 2006
• Anticipated Study Completion Date: May 1, 2008

Outcome Measures

Primary Outcome Measures

1. Safety of the vaccine [28 days post-dose]

Secondary Outcome Measures

1. Immunogenicity of vaccine [60 days post-dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

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, Queen Elizabeth II Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00336115
• Other Study ID Numbers: qeii
• First Posted: Jun 12, 2006
• Last Update Posted: Oct 23, 2007
• Last Verified: Oct 1, 2007

• Keywords provided by , ,: pertussis; bone marrow transplant
• Additional relevant MeSH terms: Whooping Cough

Study Results

No Results Posted as of Oct 23, 2007