Plain English Summary
Background and study aims
Meningococci are a type of bacteria that cause serious infections. They are usually carried harmlessly in the oropharynx (part of the throat) but sometimes cause devastating disease. The trialists collected samples of meningococci carried by 14,000 – 18,000 sixth form students for three consecutive years between 1999 and 2001, before and after the introduction of meningococcal C conjugate (MCC) vaccines. This corresponded to a time of unprecedented meningococcal disease incidence, the highest seen in the postwar period and 45 times higher than current disease incidence. The trialists propose to collect a similar sample of carried meningococci 15 years later at a time of unusually low disease incidence and prior to any changes in the national immunization schedule involving MCC vaccine boosters to teenagers and the introduction of the novel vaccine Bexsero® into the infant schedule. We will then carry out a genetic study comparing disease and carriage meningococci from high and low incidence periods. This study aims to answer the following questions: What are the genetic characteristics that define invasive epidemic meningococci? How has the population of meningococci changed over the last 15 years? What are the risk factors for meningococcal carriage?
Who can participate?
Participants should be in school years 12 or 13 (S5 and S6 in Scotland) and aged 15-19 years in full-time or part-time education, or aged 16-19 years in the general community.
What does the study involve?
It involves taking a single swab from the back of the throat and completing a brief questionnaire about participants and their lifestyle. In Glasgow, a single saliva sample is also collected.
What are the possible benefits and risks of participating?
By taking part, participants help improve understanding of meningococcal disease and carriage, and how to use vaccines to best protect other people in the future. There is no direct benefit to participants themselves. Some people find a throat swab either tickly or a bit unpleasant but this only lasts only a few seconds.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
September 2014 to August 2015
Who is funding the study?
Wellcome Trust (UK)
Who is the main contact?
Dr Jenny MacLennan
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
17214
Study information
Scientific title
A multicentre cross-sectional study of meningococcal oropharyngeal carriage in healthy teenagers in the UK
Acronym
Study hypothesis
Background: Meningococci are usually carried harmlessly in the oropharynx but sometimes cause devastating invasive disease. The trialists undertook surveys of oropharyngeal carriage of meningococci for three consecutive years between 1999 and 2001 before and after the introduction of meningococcal C conjugate (MCC) vaccines and established large collections of carried isolates. This corresponded to a time of unprecedented meningococcal disease incidence, the highest seen in the postwar period and 45 times higher than current disease incidence. The trialists propose to collect a similar sample of carried meningococci 15 years later at a time of unusually low disease incidence and prior to any changes in the national immunization schedule involving MCC vaccine boosters to teenagers and the introduction of the novel vaccine Bexsero® into the infant schedule. These samples will form the basis of a genetic association study of the whole genome sequences of representative disease and carriage meningococcal isolates from high and low incidence periods.
Questions it will answer: What are the genetic characteristics that define invasive epidemic meningococci? How has the population of meningococci changed over the last 15 years? What are the risk factors for meningococcal carriage?
Why is this important?: By comprehensively cataloguing genome-wide meningococcal variation in well characterized isolates with different phenotypes, these studies will identify the population of circulating meningococci, and will improve our understanding of epidemic meningococci and why meningococcal disease incidence varies over time.
Potential benefits: This research will help guide decisions on national immunisation strategies for meningococcal vaccines in the future.
Study design: A multicentre cross-sectional observational survey of meningococcal carriage with a questionnaire in 18,000 healthy teenagers aged 15-19 years.
Ethics approval(s)
First MREC approval date 18/08/2014, ref: 14/SC/1163
Study design
Non-randomised; Observational; Design type: Cross-sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Study setting(s)
School
Study type
Screening
Patient information sheet
The patient information sheet has been localised for each centre with local contact details on each sheet. Link to the Patient Information Sheet for Oxford: http://www.ukmencar4.org/oxford.html
Condition
Topic: Children, Primary Care; Subtopic: All Diagnoses, Other Primary Care; Disease: All Diseases, All Diseases
Intervention
Estimating the rate of oropharyngeal carriage of Neisseria meningitidis and the risk factors for carriage in sixth form students at a single visit with no follow up.
Intervention type
Other
Primary outcome measure
Rates of oropharyngeal carriage of Neisseria meningitidis measured at baseline as determined by culture of Neisseria meningitidis from a throat swab
Secondary outcome measures
1. To determine rates of meningococcal carriage according to the serogroup and genogroup of cultured organisms from the throat swab
2. To identify risk factors associated with meningococcal carriage as determined by answers to a one-page questionnaire
3. To evaluate the relationship between salivary antibodies, smoking and meningococcal carriage as determined by measurements from saliva samples from Glasgow students
Overall study start date
01/09/2014
Overall study end date
31/08/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participant is willing and able to give informed consent for participation in the study
2. Male or female
3. In school years 12 or 13 (S5 and S6 in Scotland) and aged 15-19 years in full time or part time education, or aged 16-19 years in the general community
Target Gender: Male & Female; Upper Age Limit 19 no age limit or unit specified; Lower Age Limit 15 no age limit or unit specified
Participant type(s)
Patient
Age group
Child
Lower age limit
15 Years
Upper age limit
19 Years
Sex
Both
Target number of participants
Planned Sample Size: 18000; UK Sample Size: 18000
Participant exclusion criteria
1. Not willing or able to give informed consent
2. Outside the specified age range
Recruitment start date
01/09/2014
Recruitment end date
31/08/2015
Locations
Countries of recruitment
United Kingdom
Study participating centre
University of Oxford
Oxford
OX1 3PS
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Wellcome Trust Centre for Human Genetics
Oxford
OX3 7BN
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Charity
Funder name
Wellcome Trust (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No |