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 |
| EudraCT/CTIS number | 2009-011587-11 |
| Secondary identifying numbers | 8541 |
- 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
Contact information
Dr Juliet Gray
Scientific
Scientific
Southampton University Hospitals NHS Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom
| jcgray@soton.ac.uk |
Study information
| Study design | Multicentre non-randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 07/09/2010 |
| Completion date | 01/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 120; UK sample size: 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
- England
- United Kingdom
Study participating centre
Southampton University Hospitals NHS Trust
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| Website | http://www.suht.nhs.uk/home.aspx |
|---|---|
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-1207-15250)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 20/05/2019 | No | No | ||
| Results article | results | 22/08/2020 | 18/06/2020 | Yes | No |
| Results article | results | 01/07/2020 | 18/06/2020 | Yes | No |
| Plain English results | 20/05/2021 | 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.
