Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000773639
Ethics application status
Approved
Date submitted
1/12/2005
Date registered
2/12/2005
Date last updated
13/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The immunogenicity of 7-valent pneumococcal conjugate vaccine (PCV-7) in
allogeneic bone marrow transplant recipients
Scientific title
The immunogenicity of 7-valent pneumococcal conjugate vaccine (PCV-7) in
allogeneic bone marrow transplant recipients
Secondary ID [1] 222 0
Conjugate Pneumococcal or PCV-7 vaccine
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient is scheduled to have allogeneic bone marrow transplantation (mathced realted or unrealted) excluding cord transplant. 929 0
Condition category
Condition code
Surgery 998 998 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 782 0
Prevention
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 1329 0
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.
Timepoint [1] 1329 0
Secondary outcome [1] 2370 0
1.pneumococcal serotype specific IgG avidity after each dose to assess immunological memory
Timepoint [1] 2370 0
Secondary outcome [2] 2371 0
2.functional antibody assays using opsonophagocytosis
Timepoint [2] 2371 0
To be done at 12 months only.
Secondary outcome [3] 2372 0
3.antibody response to the carrier protein pre and post vaccination.
Timepoint [3] 2372 0

Eligibility
Key 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.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be randomised by a personal computer which records, in a secure fashion, all patients randomised. The study will be open randomised . However, the samples will be tested blind to vaccination allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
SPSS computerised statistical softwear been used to generate the sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1095 0
Government body
Name [1] 1095 0
NHMRC CCRE in Infectious Diseases and Haematology
Country [1] 1095 0
Australia
Primary sponsor type
Individual
Name
Investigator driven study
Address
Country
Secondary sponsor category [1] 955 0
Individual
Name [1] 955 0
Investigator driven study
Address [1] 955 0
Country [1] 955 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2398 0
Western Sydney Area Health Service
Ethics committee address [1] 2398 0
Ethics committee country [1] 2398 0
Australia
Date submitted for ethics approval [1] 2398 0
Approval date [1] 2398 0
Ethics approval number [1] 2398 0

Summary
Brief summary
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.



PATIENT INFORMATION SHEET.

STUDY TITLE: The immunogenicity of 7-valent pneumococcal conjugate vaccine (PCV-7) in
allogeneic bone marrow transplant recipients

We will also ask a group of patients who had a allogeneic bone marrow transplant over 12 months ago, who return for PPV vaccination as part of their routine care, if we can test their blood, as well as take a nose and throat swab, before and after vaccination. The immune response in this group will be tested as a comparison to the two schedules of the new vaccine.

In this study, we will compare their immune response (as measured by antibodies in the blood) to two and three doses of the new vaccines, and to PPV alone. We will also look at whether immunity is improved by boosting with the old vaccine at the end. If the new vaccine offers better protection, this has implications for the development and use of the new pneumococcal vaccines for patients who have had allogeneic bone marrow transplants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36056 0
Address 36056 0
Country 36056 0
Phone 36056 0
Fax 36056 0
Email 36056 0
Contact person for public queries
Name 9971 0
Associate Professor Raina MacIntyre
Address 9971 0
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases

Children Hospital at Westmead
Level 2
Clinical Sciences Building (CSB)
Westmead NSW 2145
Country 9971 0
Australia
Phone 9971 0
+61 2 98451329
Fax 9971 0
+61 2 98453095
Email 9971 0
[email protected]
Contact person for scientific queries
Name 899 0
Associate Professor Ken Bradstock
Address 899 0
Westmead Hospital
Level 2
Institute of Clinical Pathology and Medical Research (ICPMR) Building
Darcy Road
Westmead NSW 2145
Country 899 0
Australia
Phone 899 0
+61 2 98457073
Fax 899 0
+61 2 96892331
Email 899 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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