Paediatric post pneumococcal conjugate vaccine study
Research type
Research Study
Full title
Paediatric post pneumococcal conjugate vaccine nasopharyngeal carriage study
IRAS ID
136380
Contact name
Saul Faust
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
ISRCTN Number
UKCRN 17575
Duration of Study in the UK
6 years, 11 months, 30 days
Research summary
This study aims to build upon the work undertaken for our previous studies, ‘Understanding changes in the molecular epidemiology of pneumococci carried in the nasopharynx amongst children after the introduction of pneumococcal conjugate vaccines’ (REC No. 06/Q1704/105) and ‘Analysis of the microbial community of the upper respiratory tract to support the development of effective vaccine policy’ (REC No. 11/SC/0518).
Vaccines called Prevenar 7 and Prevenar 13 were introduced into the infant immunisation programme in the UK, in 2006 and 2010 respectively, to prevent meningitis and other forms of pneumococcal infection (both serious and less serious). We intend to study whether bacteria, in particular Streptococcus pneumoniae (S. pneumoniae) and other disease-causing types of bacteria that are carried in the upper airways of children and adults have varied since the introduction of the Prevenar vaccines. The principal aim of this study is to gain a collection of bacteria from the back of each participant's nose that can be used to help investigate any changes that occur in the epidemiology of disease causing bacteria carried in the upper airways, as carriage is an indicator of the subtypes of bacteria that will cause invasive disease in the population (bacteria have to be carried in order to cause disease).
Swabs from the back of the nose (Nasopharyngeal swabs) will be taken from up to 1,000 children aged 4 years and under in each year of the study. We will also ask to take a nasal swab, but this will be optional. Nasopharyngeal and nose swabs will be processed using traditional diagnostic microbiology techniques and bacterial isolates further characterised using molecular methods. The contents of the swabs will also be stored in microbial media for future molecular analysis of the microbial flora. We will also ask parents to complete a short questionnaire requesting basic demographic data, vaccine history, information regarding recent illness and recent antibiotic usage.
The study will contribute to the continued success of the introduction of the Prevenar vaccines and will play a central role in maintaining confidence. The study will also help provide information for future vaccine policy and vaccine development as further pneumococcal conjugate vaccines, and indeed other vaccines such as the new meningococcal B vaccine, are introduced against bacteria in the airways which cause disease, blood poisoning (sepsis) and meningitis.
REC name
North of Scotland Research Ethics Committee 1
REC reference
14/NS/1064
Date of REC Opinion
24 Sep 2014
REC opinion
Favourable Opinion