Pneumococcal conjugate vaccine in acute lymphoblastic leukaemia
Research type
Research Study
Full title
Investigating the Clinical use of 13-Valent Pneumococcal Conjugate Vaccine (Prevenar)in Childhood Acute Lymphoblastic Leukaemia
IRAS ID
27422
Contact name
Juliet Gray
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Eudract number
2009-011587-11
ISRCTN Number
n/a
Research summary
Acute Lymphoblastic Leukaemia (ALL) is the commonest children’s cancer with long-term survival of over 80%. As survival rates increase, more of these children will be reintegrated into day care and school once treatment is complete and will be highly exposed to infections. Therefore it is important to protect these children against infections, particularly against vaccine-preventable diseases. Treatment of ALL involves 2-3 years of chemotherapy. The effects of chemotherapy on the immune system make children extremely prone to infection during this prolonged period. In particular these children are at very high risk of life-threatening pneumococcal infections including meningitis, pneumonia and septicaemia. It is important that a strategy for prevention of pneumococcal infection is developed to target these susceptible patients.
The pneumococcal conjugate vaccine (PCV) was introduced into the UK routine childhood immunization programme in 2006. This vaccine has been shown to be safe and effective in other groups of children with decreased immunity but its effectiveness in children receiving chemotherapy has not yet been studied. This study aims to demonstrate that vaccination with PCV can be used to protect children being treated for leukaemia from severe pneumococcal infections. If this is the case, PCV immunisation will be offered to all children receiving treatment for acute leukaemia.
This study will be conducted in 3 paediatric oncology centres (Southampton, Royal Marsden and Great Ormond Street). There will be 3 study groups: children receiving maintenance chemotherapy for ALL, children who have recently completed treatment and children who have completed treatment 6 months earlier. We plan to recruit 120 children (40 per group) over a period of 2 years. Children will receive a single dose of PCV and then undergo blood tests to check antibody levels (before vaccination and 1 and 12 months after vaccination), to determine whether they have developed protective pneumococcal immunity.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
09/H0504/112
Date of REC Opinion
11 Feb 2010
REC opinion
Further Information Favourable Opinion