Pneumonia Vaccine in Bone Marrow Transplant Recipients: Usefulness of Donor Vaccination

NCT00143780 | Completed Phase 4

• 2 other identifiers: 02-0182-CP.S.I. Grant No. 02-67
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Marrow Transplant

Keywords

Bone Marrow Transplant; Pneumonia; Vaccine; Conjugate Vaccine; Polysaccharide Vaccine

Outcome Measures

Primary Outcomes (1)

• Immunogenicity of two vaccines via a determination of serotype specific capsular antibody formation and functional antibody formation from donor and recipient serum.

Secondary Outcomes (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.

Interventions

The polysaccharide vaccine used is Pneumovax (Merck vaccines) BIOLOGICAL

The conjugate vaccine used is Prevnar (Wyeth-Ayerst vaccines) BIOLOGICAL

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Deepali Kumar, BSc, MSc, MD, FRCP(C)

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: May 1, 2002
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: April 16, 2008

Record last verified: 2005-08

Locations

CA (1)