Protection against Pneumococcal infection in children with T1DM
Research type
Research Study
Full 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.
IRAS ID
118340
Contact name
Dominic Kelly
Contact email
Sponsor organisation
University of Oxford
Eudract number
2013-001024-19
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
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.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
13/SC/0199
Date of REC Opinion
2 Jul 2013
REC opinion
Further Information Favourable Opinion