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	Intervention	Phase
Bone Marrow Transplant	Vaccine: The polysaccharide vaccine used is PneumovaxTM (Merck vaccines)  Vaccine: The conjugate vaccine used is PrevnarTM (Wyeth-Ayerst vaccines)	Phase IV

Further Study Details: 

Primary Outcomes: Immunogenicity of two vaccines via a determination of serotype specific capsular antibody formation and functional antibody formation from donor and recipient serum.
Secondary Outcomes: 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.
Expected Total Enrollment:  100

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.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00143780

Deepali Kumar, BSc, MSc, MD, FRCP(C)      416-340-4800  Ext. 6628    Deepali.Kumar@uhn.on.ca
Atul Humar, MD, MSc, FRCPC.      416-340-4800  Ext. 6752    Atul.Humar@uhn.on.ca

Canada, Ontario
      University Health Network-Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada; Recruiting

Study chairs or principal investigators

Deepali Kumar, BSc, MSc, MD, FRCP(C),  Principal Investigator,  University Health Network   

Study ID Numbers:  02-0182-C; P.S.I. Grant No. 02-67
Last Updated:  September 1, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00143780
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-06