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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
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
University Health Network, Toronto

Brief Summary:
Streptococcus pneumoniae, also known as Pneumococcus, is a common cause of pneumonia in transplant patients. There has been a vaccine available for this infection called Pneumovax. Recently, a new vaccine for this infection called Prevnar has been developed which may be more effective. Vaccinating the bone marrow donor before transplant may boost the recipient's immune response to the vaccine after transplant. This study is done to compare how vaccinating the donor with one of the vaccines will affect the recipient's immune system response to the vaccine.

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

Detailed Description:

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)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
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
Primary Completion Date : July 2006
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Immunogenicity of two vaccines via a determination of serotype specific capsular antibody formation and functional antibody formation from donor and recipient serum.

Secondary Outcome Measures :
  1. 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.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Recipient - Adult male or female marrow recipients who fulfill the following criteria will be eligible for the study: a) Will undergo allogeneic-HSCT in 2-3 weeks.

b) No splenectomy c) Not currently receiving IVIG d) Able to provide written informed consent and comply with study protocol e) Age > 16

Donor - Adult male or female marrow donors who fulfill the following criteria will be eligible for the study:

  1. Recipient of donor marrow agrees to participate in study.
  2. No prior pneumococcal vaccination within the last 5 years
  3. Not on immunosuppressive medication (eg., corticosteroids)
  4. No history of immunosuppressive condition that may potentially impair vaccine response eg, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis
  5. No splenectomy
  6. Able to provide written informed consent and comply with study protocol
  7. Age > 16

Information from the National Library of Medicine

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


Locations
Canada, Ontario
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Deepali Kumar, BSc, MSc, MD, FRCP(C) University Health Network, Toronto

ClinicalTrials.gov Identifier: NCT00143780     History of Changes
Other Study ID Numbers: 02-0182-C
P.S.I. Grant No. 02-67
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: August 2005

Keywords provided by University Health Network, Toronto:
Bone Marrow Transplant
Pneumonia
Vaccine
Conjugate Vaccine
Polysaccharide Vaccine

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs