None listed
Conditions
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.
Interventions
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)
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.
Sponsors
Investigator driven study
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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.
Outcome results
None listed