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

ISRCTN	ISRCTN12861513
DOI	https://doi.org/10.1186/ISRCTN12861513
Clinical Trials Information System (CTIS)	2009-011587-11
Protocol serial number	8541
Sponsor	Southampton University Hospitals NHS Trust (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-1207-15250)

Submission date: 21/10/2010
Registration date: 21/10/2010
Last edited: 20/05/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Juliet Gray
Scientific

Southampton University Hospitals NHS Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom

Email	jcgray@soton.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre non-randomised interventional treatment trial
Secondary study design	Non randomised study
Study type	Participant information sheet
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
Study acronym	PCV (Pneumococcal Conjugate Vaccine)
Study objectives	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 therapy 2. At the end of chemotherapy treatment 3. Six months after completion of treatment
Ethics approval(s)	Southampton and South West Hampshire REC, Committee B, 11/02/2010, ref: 09/HO504/112
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)
Primary outcome measure(s)	Serum concentrations of IgG anti-capsular polysaccharide antibodies to pneumococcal serotypes, measured at 0, 1 and 12 months post-immunisation
Key secondary outcome measure(s)	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
Completion date	01/09/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	120
Total final enrolment	118
Key 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)
Key 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
Date of first enrolment	07/09/2010
Date of final enrolment	01/09/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Southampton University Hospitals NHS Trust

Southampton
SO16 6YD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/08/2020	18/06/2020	Yes	No
Results article	results	01/07/2020	18/06/2020	Yes	No
Basic results			20/05/2019	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			20/05/2021	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/05/2021: added CRUK link to plain English results.
18/06/2020: Publication references added.
20/05/2019: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
13/02/2018: No publications found in PubMed, verifying study status with principal investigator.
26/11/2015: no publications found on PubMed.