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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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22 February 2013 |
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Main ID: |
ACTRN12605000773639 |
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Date of registration:
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02/12/2005 |
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Primary sponsor: |
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Public title:
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The immunogenicity of 7-valent pneumococcal conjugate vaccine (PCV-7) in
allogeneic bone marrow transplant recipients
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Scientific title:
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The immunogenicity of 7-valent pneumococcal conjugate vaccine (PCV-7) in
allogeneic bone marrow transplant recipients |
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Date of first enrolment:
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3/11/2006 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://www.anzctr.org.au/ACTRN12605000773639.aspx |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial
Parallel |
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Countries of recruitment
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Australia
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Contacts
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Name:
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Associate Professor Raina MacIntyre |
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Address:
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National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
Children Hospital at Westmead
Level 2
Clinical Sciences Building (CSB)
Westmead NSW 2145, Australia
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Telephone:
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+61 2 98451329 |
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Email:
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RainaM@chw.edu.au |
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Affiliation:
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Name:
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Associate Professor Ken Bradstock |
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Address:
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Westmead Hospital
Level 2
Institute of Clinical Pathology and Medical Research (ICPMR) Building
Darcy Road
Westmead NSW 2145, Australia
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Telephone:
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+61 2 98457073 |
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Email:
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kbradstok@icpmr.wsahs.nsw.gov.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Any patient undergoing allogeneic bone marrow transplantation (mathced related or unrelated) at Westmead Hospital who has not received pneumococcal vaccine wil be eligible.
Exclusion criteria: Subjects with a history of pneumococcal Vaccination (as determined by self-report and validation by general practitioner records) will be ineligible. Subjects who are thrombocytopaenic or have any other bleeding disorder at the time of vaccination will be ineligible.
Age minimum:
0 Not stated
Age maximum:
0 Not stated
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Patient is scheduled to have allogeneic bone marrow transplantation (mathced realted or unrealted) excluding cord transplant.
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Intervention(s)
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The bacteria pneumococcus (also known as Streptococcus pneumoniae) is the most common cause of pneumonia in the community, and a major cause of illness and death in people with low immunity; it can particularly be a problem after allogeneic bone marrow transplantation, which results in impaired immunity. Patients who receive grafts from an unrelated donor are particularly at risk. This infection can be prevented by vaccination. In fact, the National Health and Medical Research Council (NHMRC) of Australia recommend that all people with impaired immunity, including those who have had an allogeneic bone marrow transplant, should be vaccinated. The vaccine that has been used for many years is called the polysaccharide pneumococcal vaccine or PPV for short. This vaccine has been available for a long time in Australia, but unfortunately it is known to be less effective in people with impaired immune systems.
The PPV vaccine had the same problem in young children, and so a new vaccine was developed for children. This new pneumococcal vaccine is called conjugate pneumococcal vaccine, or PCV-7, and has been available since the end of 2000 but only used in children, as it was developed for children and has not been extensively tested in adults. This vaccine uses different technology, and is much more effective in young children than the old vaccine. Clinical trials of PCV-7 have largely been limited to children under 5 years of age and have shown it protects 93.9% of children under 2 years of age against serious pneumococcal infections. This new vaccine is routinely used in Australian children now, and is quite safe.
Our study aims to compare two versus three doses of this new vaccine (PCV-7), followed by the old vaccine (PPV) to further boost immunity, in people who are going to have an allogeneic bone marrow transplant. Patients who have not previously received pneumococcal vaccine will be randomly allocated to receive either two or three doses of PCV-7, followed by PPV.
The study will involve answering some questions regarding medical history and receiving pneumococcal vaccination. Patient will either receive
1. Three doses of the new vaccine at 3, 6 and 12 months after transplant, followed by one dose of the old vaccine at 18 months; or
2. Two doses of the new vaccine at 3 and 6 months after transplant, followed by one dose of the old vaccine at 12 months. Or
3. If the patient received two doses of the old vaccine as part of routine clinical care in the past 12 months, they will not receive vaccinations as part of the trial, but we will collect blood and nose specimens from them to test if they have been protected against pneumococcal disease from the vaccines they received as part of their routine care.
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Primary Outcome(s)
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To compare immune response to two different schedules of 7-valent pneumococcal conjugate vaccine (PCV7), followed by boosting with the 23-valent polysaccharide vaccine (PPV) in allogeneic bone marrow transplant/ stem cell transplant (SCT) recipients without a past history of vaccination with PPV.
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Secondary Outcome(s)
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1.pneumococcal serotype specific IgG avidity after each dose to assess immunological memory
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2.functional antibody assays using opsonophagocytosis
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3.antibody response to the carrier protein pre and post vaccination.
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Secondary ID(s)
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Conjugate Pneumococcal or PCV-7 vaccine
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Source(s) of Monetary Support
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NHMRC CCRE in Infectious Diseases and Haematology
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