Skip to main content
OpenTrials
Completed

NCT Number: NCT00143780

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bone Marrow Transplant Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

Treatment and study plan

The polysaccharide vaccine used is Pneumovax (Merck vaccines)

Biological

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

Biological

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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

Immunogenicity of Pneumococcal Conjugate Vaccine in Adult Allogeneic Bone Marrow Transplant Recipients - Randomized Controlled Trial of Pre-Transplant Donor Immunization

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Sep 2, 2005
Registry last updated
Apr 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.