Plain English Summary
Background and study aims
Children and young people with diabetes may be at a higher risk of getting certain infections. These infections include those caused by a bacterium called the pneumococcus which can cause pneumonia, meningitis and ear infections. In the UK it is recommended that all older children with diabetes are given a vaccine against the pneumococcus bug called Pneumovax (or PPS23 for short). However it is not actually known how well PPS23 protects against infection in children of any age. This study is looking at the use of an alternative vaccine against pneumococcus called Prevenar13 (or PCV13). PCV13 is already given routinely to all babies in the UK and also to children under 5 years of age with diabetes (if they have missed the vaccine as a baby). PCV13 is known to be a safe vaccine and to work well in these age groups. It is therefore expected that the PCV13 vaccine will also protect in older children (6-17 years of age) but there is actually not much information on the immune response or how long it lasts in older children.
Who can participate?
Children aged 6-17 with type 1 diabetes.
What does the study involve?
At the first visit, participants are told what the study involves and are asked to give their consent if they are happy to take part. Basic details about the child’s previous immunisations and any relevant medical conditions are then collected. Samples of blood are taken (if possible at the same time as any routine annual blood tests) to check antibody levels. A local anaesthetic cream or cold spray is used to to help prevent any pain. After that a single dose of PCV13 vaccine is given and the child then monitored for 15 minutes. The child is asked, with help from their family if needed. To record their daily temperature or any reaction in a diary card for the next 7 days. Each participant is asked to return for a repeat blood test at 3 months and 1 year later. Where possible, these samples are taken at the same time as the routine annual blood tests.
What are the possible benefits and risks of participating?
In this study the child would receive a single dose of PCV13 vaccine to provide protection against pneumococcal infection. This would not normally have been given to the child but would be expected to increase immunity against these bugs. The study provide the opportunity for the family to know whether the child is protected against most of the pneumococcal bacteria in the vaccine after immunisation. Like all medicines, the vaccine may cause side effects in some individuals. More common side-effects (1-10% of those vaccinated) include headaches, fever, feeling generally unwell, shivering, fatigue, loss of appetite and local reactions (e.g. redness, swelling, pain, bruising and hardness). These events are generally mild and resolve within a few days. As with all vaccines, there is the very small possibility of a severe allergic reaction (anaphylaxis).
Where is the study run from?
Oxford University Hospitals NHS Foundation Trust and Royal Berkshire NHS Foundation Trust.
When is the study starting and how long is it expected to run for?
July 2013 to December 2017
Who is funding the study?
Oxfordshire Health Services Research Committee (OHSRC) (UK)
Who is the main contact?
Mrs Rebecca Beckley
rebecca.beckley@paediatrics.ox.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Rebecca Beckley
ORCID ID
Contact details
Oxford University Hospitals
Department of Paediatrics
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
-
rebecca.beckley@paediatrics.ox.ac.uk
Additional identifiers
EudraCT number
2013-001024-19
ClinicalTrials.gov number
Protocol/serial number
14963
Study information
Scientific title
An open label single-arm study of the immunogenicity and reactogenicity of a 13-valent pneumococcal conjugate vaccine (Prevenar13®) given to children with type 1 diabetes mellitus who have not previously received a primary schedule of immunisation with pneumococcal conjugate vaccines in infancy
Acronym
Study hypothesis
There are two types of pneumococcal vaccine plain polysaccharide (PPS) and conjugate (PCV) vaccines. PPS do not induce immune responses under 2 years of age and do not induce immunological memory for the pneumococcus furthermore in adults PPS may reduce the response to subsequent doses of pneumococcal vaccine. It is uncertain whether this happens in children. PCVs were developed to overcome the limitations of PPS vaccines and are widely used in children under 5 years of age. However, there remains uncertainty about which pneumococcal vaccines are best to use in older children (over 5 years of age) who are at risk of pneumococcal disease. Furthermore there are limited data on both the response to PCVs in this age group and whether prior immunisation with PPS results in a reduced immune response. We plan to assess baseline immunity and response to a PCV (covering 13 types of pneumococcus - PCV13) in 50 children over 5 years of age with T1DM and assess this in relation to whether they have or have not previously received PPS. The children will be recruited from a group of over 250 children with T1DM under the care of the diabetes team at Oxford University Hospitals NHS Trust. The immune response will be assessed at baseline, 3 months and 12 months after immunisation. This will provide novel data on the initial immune response in this age group, persistence of immunity and the effect of PPS. This will be important data against which to consider the use of PPS and PCVs in this and other high risk populations.
Ethics approval
First MREC approval date 02/07/2013, ref: 13/SC/0199
Study design
Non-randomised interventional trial; Design type: Prevention
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases
Intervention
Primary Intervention, a single dose of 13-valent pneumococcal conjugate vaccine (PCV13)
Intervention type
Drug
Phase
Phase IV
Drug names
13-valent pneumococcal conjugate vaccine (Prevenar13®)
Primary outcome measure
The proportion of children with vaccine pneumococcal serotype specific (SpVS) antibody concentration. The immune response will be assessed at baseline, 3 months and 12 months after immunisation.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
29/07/2013
Overall trial end date
31/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosis of T1DM and being followed in the Oxfordshire Childrens Diabetes Service
2. Aged from 6-17 years old
3. Parent/legal guardian willing and able to give informed consent
4. No previous immunisation with a pneumococcal conjugate vaccine (PCV)
5. Willing to allow the General Practitioner to be notified of participation in the study
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Planned Sample Size: 50; UK Sample Size: 50
Participant exclusion criteria
1. Known allergic reaction to the vaccine antigen or any of the excipients
2. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection
Recruitment start date
20/08/2013
Recruitment end date
17/12/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford University Hospitals NHS Foundation Trust
Oxford
-
United Kingdom
Trial participating centre
Royal Berkshire NHS Foundation Trust
Berkshire
-
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Department of Clinical Pharmacology
Radcliffe Infirmary
Woodstock Road
Oxford
OX2 6HE
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Oxfordshire Health Services Research Committee (OHSRC) (UK)
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
Basic results (scientific)
Publication list