Condition category
Infections and Infestations
Date applied
17/09/2014
Date assigned
10/12/2014
Last edited
10/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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. We 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. We 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 will also be collected.

What are the possible benefits and risks of participating?
By taking part, participants will help improve our understanding of meningococcal disease and carriage, and help us understand 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?
The study will run from September 2014 to August 2015.

Who is funding the study?
Wellcome Trust (UK).

Who is the main contact?
Dr Jenny MacLennan

Trial website

http://www.ukmencar4.org/

Contact information

Type

Scientific

Primary contact

Dr Jenny MacLennan

ORCID ID

Contact details

Department of Zoology
University of Oxford
South Parks Road
Oxford
OX1 3PS
United Kingdom

Additional identifiers

EudraCT 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

N/A

Study hypothesis

Background: Meningococci are usually carried harmlessly in the oropharynx but sometimes cause devastating invasive disease. We 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. We 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.

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=17214

Ethics approval

14/SC/1163; First MREC approval date 18/08/2014

Study design

Non-randomised; Observational; Design type: Cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Schools

Trial 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

We will be estimating the rate of oropharyngeal carriage of Neisseria meningitidis and the risk factors for carriage in sixth form students. This is estimated at a single visit with no follow up.

Intervention type

Other

Phase

Drug names

Primary outcome measures

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 trial start date

01/09/2014

Overall trial end date

31/08/2015

Reason abandoned

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

Patient

Age group

Child

Gender

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

Trial 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
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

Wellcome Trust (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes