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Contact Information:

Dr Juliet Gray
-
jcgray@soton.ac.uk


Study Location:

Southampton University Hospitals NHS Trust
Southampton
SO16 6YD


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Investigating the clinical use of 13-valent pneumococcal conjugate vaccine (Prevenar) in childhood acute lymphoblastic leukaemia

Not Recruiting

Open to: All Genders

Age: Child

Medical Conditions

Topic: Medicines for Children Research Network
Subtopic: All Diagnoses
Disease: All Diseases


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-vaccine-prevent-infections-children-acute-lymphblastic-leukaemia

The main aim of this study is to produce evidence on which to base a vaccination guideline that will reduce the incidence of pneumococcal infection in children with acute leukoblastic leukaemia (ALL). This will be achieved by examining the efficacy of 13 valent conjugate pneumococcal vaccination (13vPCV) immunisation in this population. Our hypothesis is that 13vPCV will be sufficiently immunogenic to generate protective anti-pneumococcal immunity in children with ALL whilst they are receiving maintenance therapy and are most at risk of infection. However, it is possible that vaccination of children during treatment will not be effective due to the immunosuppressive effects of chemotherapy. Therefore vaccination with 13vPCV will also be tested in children at the end of their treatment and 6 months after completion of treatment. The earliest of these time points at which 13vPCV is found to achieve protective immunity will be adopted as the final recommendation for all children with ALL, in order to provide protection for as long as possible during and after their leukaemia therapy.

The main study question is therefore to identify the earliest time point that children with ALL can be effectively vaccinated with 13vPCV. In order to answer this, the study primary objective is to establish if 13vPCV can achieve protective levels of anti-pneumococcal antibodies: 1. During maintenance therapy2. At the end of chemotherapy treatment3. Six months after completion of treatment


Multicentre non-randomised interventional treatment trial

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

07 Sep 2010

01 Sep 2012

Publications

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/31586206/ results (added 18/06/2020)2020 Results article in https://doi.org/10.1002/jha2.27 results (added 18/06/2020)

Interventional

Intervention Type : Biological/Vaccine
Intervention Description : PCV-13 vaccine, single 0.5 ml dose of vaccine to each study participant.

Follow up length: 12 monthsStudy entry: otherDetails: non-random allocation to treatment group, depending on current timepoint in ALL treatment


You can take part if:


1. Aged 2 to 18 years (inclusive), either sex2. ALL confirmed by immunophenotyping at diagnosis3. Currently receiving maintenance therapy as per UKALL 2003 treatment protocol, or treatment as per UKALL 2003 protocol completed within last 6 months4. Informed consent of parent/guardian (+/- patient)




You may not be able to take part if:

1. Concomitant acquired or congenital immunodeficiency2. Concomitant immunosuppressive medication within previous 3 months, other than maintenance chemotherapy as per UKALL 2003 protocol3. Previous severe or anaphylactic reaction to PCV4. Previous severe or anaphylactic reaction to diphtheria toxoid5. Children with a contraindication to receipt of any vaccine or a specific vaccine as stated in the Department of Health Green Book on immunisation (DOH, 2006)6. Pregnancy or lactation

Routine immunisation with PCV7 prior to ALL therapy is not an exclusion criteria


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Southampton University Hospitals NHS Trust
    Southampton
    SO16 6YD


The study is sponsored by Southampton University Hospitals NHS Trust (UK) and funded by National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-1207-15250) .



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for Trial ID: ISRCTN12861513

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