Pneumonia Vaccine in Bone Marrow Transplant Recipients: Usefulness of Donor Vaccination
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|ClinicalTrials.gov Identifier: NCT00143780|
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : April 16, 2008
|Condition or disease||Intervention/treatment||Phase|
|Bone Marrow Transplant||Biological: The polysaccharide vaccine used is Pneumovax (Merck vaccines) Biological: The conjugate vaccine used is Prevnar (Wyeth-Ayerst vaccines)||Phase 4|
This is a randomized controlled trial designed to assess the immunogenicity of the new pneumococcal conjugate vaccine in a cohort of allogeneic hematopoietic stem cell transplant (allo-HSCT) recipients. This will be done by using an approach of pre-transplant donor immunization with post-transplant recipient immunization. Response will be compared with the standard 23-valent polysaccharide vaccine. It is hypothesized that the conjugate vaccine will provide an enhanced response in this group of immunosuppressed individuals who respond poorly to standard polysaccharide vaccines.
Specific objectives of this study are:
- To determine the antibody response to both vaccines via a measurement of total antibody response and by the opsonophagocytic assay. This assay has the advantage of assessing if patient antibody responses represent truly functional antibodies that display opsonic activity against pneumococcus and is likely better correlated with protective efficacy.
- To determine any acute adverse reactions of the conjugate vaccine in this population. Results of this trial will help lay the foundation for the development of a rationale and optimal pneumococcal vaccination strategy that would prevent significant morbidity in this patient population.
We hypothesize that pneumococcal conjugate vaccine, due to its T-cell dependent response will have greater immunogenicity and protective effect in an allo-HSCT population by using a donor immunization strategy.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Immunogenicity of Pneumococcal Conjugate Vaccine in Adult Allogeneic Bone Marrow Transplant Recipients - Randomized Controlled Trial of Pre-Transplant Donor Immunization|
|Study Start Date :||May 2002|
|Actual Primary Completion Date :||July 2006|
|Actual Study Completion Date :||July 2006|
- Immunogenicity of two vaccines via a determination of serotype specific capsular antibody formation and functional antibody formation from donor and recipient serum.
- All patients will be called by telephone 24 hours after receiving vaccine to determine if any acute adverse events occurred. Any occurance of pneumococcal disease in recipients for one year post-transplant during the study period will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143780
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Deepali Kumar, BSc, MSc, MD, FRCP(C)||University Health Network, Toronto|