Status:
UNKNOWN
Pneumonia Vaccine in Liver Transplant Recipients: a Booster Strategy Using a Conjugate Vaccine
Lead Sponsor:
University Health Network, Toronto
Conditions:
Transplant
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
The trial will compare a group of patients whose immune system is primed with the pneumococcal conjugate vaccine and then given a boost with polysaccharide vaccine (prime-boost strategy) vs. a group v...
Detailed Description
OBJECTIVE: Responses to 23-valent polysaccharide pneumococcal vaccine (PPV23) are poor in organ transplant recipients. We have recently shown that the conjugate pneumococcal vaccine (PCV7) is immunoge...
Eligibility Criteria
Inclusion
- Male or female outpatients who fulfill the following criteria will be eligible for the study:
- Liver transplant recipients greater than 3 months post-transplant
- No prior pneumococcal vaccination within the last 5 years
- Stable allograft function as evidenced by a alanine aminotransferase \<10 times the upper limit of normal (mmol/L) that is not worsening
- Able to provide written informed consent and comply with study protocol
- Age \> 16
Exclusion
- Unable to provide informed consent or comply with protocol
- Prior pneumococcal vaccination within 5 years of enrolment
- Splenectomy
- Admitted to hospital for acute illness
- Febrile illness in the past 2 weeks
- Intravenous Immunoglobulin in the last 6 months
- Current episode of allograft rejection
- Currently on full-dose anticoagulation as a contraindication to intramuscular injection
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2009
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00152802
Start Date
January 1 2005
End Date
January 1 2009
Last Update
February 19 2007
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G2N2