The Bristol Meningococcal Natural History of Carriage study
| ISRCTN | ISRCTN98439755 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98439755 |
| Secondary identifying numbers | 17811 |
- Submission date
- 04/02/2015
- Registration date
- 14/04/2015
- Last edited
- 18/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
The meningococcus is a bug that commonly lives at the back of the throat without causing any symptoms in people carrying it. Meningitis and blood poisoning are very serious diseases that can be caused by meningococcus (and some other bugs). Although only very few people get these diseases, teenagers and young children are at increased risk. A national meningococcal carriage study in seven UK sites is collecting one throat swab each from 18,000 healthy 15-19 year old school/college students. Of these, around 2,500 will be recruited in Bristol. The national study will show how many teenagers were carrying the bug on the day they had their swab taken, but it cannot show whether or how this changes over time. This new study is a follow-on to the national study. The aim of this additional study is to look at the natural changes in meningococcus carriage in greater detail.
Who can participate?
Healthy male and female students aged 15 to 19 years attending participating schools/colleges in Bristol who are enrolled in the meningococcal carriage study, and who agreed to be re-approached for this study.
What does the study involve?
Five further (monthly) throat swabs are taken from 1,000 of the Bristol participants of the national study. The participants are also asked to complete a brief questionnaire about factors that may affect meningococcus carriage (smoking, antibiotic use etc) at the time of each swab. The aims are to find out whether some people carry a larger number of bugs than others (high versus low carriers), whether the amount of bug carried changes over time, how many people naturally stop carrying the bug, and how many who didn’t previously have it start carrying it (acquisition).
What are the possible benefits and risks of participating?
Understanding exactly how meningococcus carriage varies naturally provides important information to help use existing vaccines more effectively and develop better ones in the future.
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
November 2014 to June 2017
Who is funding the study?
National Institute of Health Research (NIHR) Health Protection Research Unit (HPRU) Evaluation of Interventions (UK)
Who is the main contact?
Dr Jennifer Oliver
jennifer.oliver@bristol.ac.uk
Contact information
Scientific
Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
Scientific
Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
 ORCID ID |
0000-0003-1756-5668 |
|---|
Study information
| Study design | Non-randomised; Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Follow on study of meningococcal carriage in 15-19 year old school students: description of the natural history of colonisation and development of laboratory and epidemiological tools for detailed studies of the potential impact of novel vaccines upon transmission |
| Study hypothesis | Aim: To provide a detailed picture of the natural history of meningococcal carriage in adolescents in whom carriage and transmission is relatively common, and who are a potential target group both for vaccine studies to evaluate impact on carriage and transmission, and ultimately for intervention with universal immunisation programmes. Objectives: Among 15-19 year old students in Bristol, UK: 1. Describe the distribution of carriage density 2. Provide detailed information on the duration of carriage 3. Provide detailed information on rates of acquisition of carriage 4. Clarify heterogeneity in patterns of carriage and specifically to what extent high density and long duration carriage characterises one or more specific subgroups of individuals |
| Ethics approval(s) | NRES Committee London - Bromley, 14/07/2014, ref: 14/LO/1332 |
| Condition | Topic: Children; Subtopic: All Diagnoses; Disease: All Diseases |
| Intervention | Oropharyngeal swab, 5 swabs, one at each visit; questionnaire, 5 short questionnaires on risk factors of meningococcal carriage, one at each visit; Study Entry: Registration only |
| Intervention type | Other |
| Primary outcome measure | Distribution of carriage density; Timepoint(s): At entry and over the course of the study |
| Secondary outcome measures | 1. Acquisition of carriage; Timepoint(s): rates over the course of the study 2. Duration of carriage; Timepoint(s): Over the course of the study 3. Patterns of carriage; Timepoint(s): heterogeneity over study period between subgroups, especially high density and long duration carriage |
| Overall study start date | 05/11/2014 |
| Overall study end date | 30/06/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 15 Years |
| Upper age limit | 19 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1000; UK Sample Size: 1000 |
| Participant inclusion criteria | The study will recruit healthy male and female students aged 15 to 19 years attending participating schools/colleges in Bristol who are enrolled in the Wellcome Trust funded cross-sectional meningococcal carriage study, and whose consent for that study included agreement to potentially be re-approached concerning this study. All subjects must provide signed informed consent to participate in this longitudinal study. Target Gender: Male & Female; Upper Age Limit 19 years ; Lower Age Limit 15 years |
| Participant exclusion criteria | Any medical condition or circumstances which, in the opinion of the investigator, will jeopardise the likelihood of safe or effective participation in the study |
| Recruitment start date | 05/11/2014 |
| Recruitment end date | 31/03/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
Sponsor information
Hospital/treatment centre
Senate House
Tyndall Avenue
Bristol
BS8 1TH
England
United Kingdom
"ROR" |
https://ror.org/0524sp257 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/05/2021 | 18/02/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
18/02/2022: Publication reference added.
02/06/2017: The overall trial end date was changed from 30/06/2016 to 30/06/2017.
