ANZCTR - Registration

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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]

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.

Condition category

Condition code

Surgery

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]

Prevention

Comparator / control treatment

Control group

Dose comparison

Outcomes

Primary outcome [1]

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]

Secondary outcome [1]

1.pneumococcal serotype specific IgG avidity after each dose to assess immunological memory

Timepoint [1]

Secondary outcome [2]

2.functional antibody assays using opsonophagocytosis

Timepoint [2]

To be done at 12 months only.

Secondary outcome [3]

3.antibody response to the carrier protein pre and post vaccination.

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC CCRE in Infectious Diseases and Haematology

Address [1]

Country [1]

Australia

Primary sponsor type

Individual

Name

Investigator driven study

Address

Country

Secondary sponsor category [1]

Individual

Name [1]

Investigator driven study

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Area Health Service

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Associate Professor Raina MacIntyre

Address

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

Australia

Phone

+61 2 98451329

Fax

+61 2 98453095

RainaM@chw.edu.au

Contact person for scientific queries

Name

Associate Professor Ken Bradstock

Address

Westmead Hospital
Level 2
Institute of Clinical Pathology and Medical Research (ICPMR) Building
Darcy Road
Westmead NSW 2145

Country

Australia

Phone

+61 2 98457073

Fax

+61 2 96892331

kbradstok@icpmr.wsahs.nsw.gov.au

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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Documents added automatically

No additional documents have been identified.

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