Contact information
Type
Scientific
Primary contact
Dr Juliet Gray
ORCID ID
Contact details
Southampton University Hospitals NHS Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom
-
jcgray@soton.ac.uk
Additional identifiers
EudraCT number
2009-011587-11
ClinicalTrials.gov number
Protocol/serial number
8541
Study information
Scientific title
Investigating the clinical use of 13-valent pneumococcal conjugate vaccine (Prevenar) in childhood acute lymphoblastic leukaemia: a multicentre non-randomised interventional treatment trial
Acronym
PCV (Pneumococcal Conjugate Vaccine)
Study hypothesis
he 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 therapy
2. At the end of chemotherapy treatment
3. Six months after completion of treatment
Ethics approval
Southampton and South West Hampshire REC, Committee B, 11/02/2010, ref: 09/HO504/112
Study design
Multicentre non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases
Intervention
PCV-13 vaccine, single 0.5 ml dose of vaccine to each study participant.
Follow up length: 12 months
Study entry: other
Details: non-random allocation to treatment group, depending on current timepoint in ALL treatment
Intervention type
Biological/Vaccine
Phase
Phase IV
Drug names
Primary outcome measures
Serum concentrations of IgG anti-capsular polysaccharide antibodies to pneumococcal serotypes, measured at 0, 1 and 12 months post-immunisation
Secondary outcome measures
1. Nasopharyngeal carriage of pneumococcal sp (including serotpye and MLST), measured at 0 and 12 months post-immunisation
2. Opsonophagocytosis assay (OPA) against two pneumococcal serotypes, measured at 0, 1 and 12 months post-immunisation
3. Peripheral blood lymphocyte subsets, measured at 0 and 12 months post-immunisation
4. Serum concentrations of total immunoglobulins and IgG subclasses, measured at 0 and 1 months post-immunisation
Overall trial start date
07/09/2010
Overall trial end date
01/09/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 2 to 18 years (inclusive), either sex
2. ALL confirmed by immunophenotyping at diagnosis
3. Currently receiving maintenance therapy as per UKALL 2003 treatment protocol, or treatment as per UKALL 2003 protocol completed within last 6 months
4. Informed consent of parent/guardian (+/- patient)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Planned sample size: 120; UK sample size: 120
Participant exclusion criteria
1. Concomitant acquired or congenital immunodeficiency
2. Concomitant immunosuppressive medication within previous 3 months, other than maintenance chemotherapy as per UKALL 2003 protocol
3. Previous severe or anaphylactic reaction to PCV
4. Previous severe or anaphylactic reaction to diphtheria toxoid
5. 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
Recruitment start date
07/09/2010
Recruitment end date
01/09/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southampton University Hospitals NHS Trust
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Southampton University Hospitals NHS Trust (UK)
Sponsor details
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-1207-15250)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary