Plain English Summary
Background and study aims
Teenagers and young children are at increased risk of diseases such as meningitis and blood poisoning due to bacteria called meningococcus. Although these diseases can be serious, the meningococcus bacteria are carried in the back of the throat of 1 in 10 teenagers without causing any symptoms. Most meningococcal disease in teenagers is due to Meningitis B (also known as MenB). The aim of this study is to see whether immunising teenagers with vaccines against MenB can reduce the number of teenagers carrying these bacteria in their throat. This would be important because it could mean that teenage MenB immunisation would not only help protect teenagers against these potentially deadly diseases, but also that babies, children and older adults are less likely to be exposed to the bacteria. In short, immunising teenagers with a MenB vaccine might mean lower rates of meningococcal disease across all ages.
Who can participate?
Students aged 16-18 attending year 12 (or equivalent) at one of the participating 6th form colleges in England, Scotland and Wales
What does the study involve?
Participating schools are randomly allocated to deliver one of two types of MenB vaccine: 4CMenB (also known as Bexsero) and MenB-fHBP (also known as Trumenba). Participants either get two doses of 4CMenB or MenB-fHBP given 6 months apart at their first two study visits, or two doses of 4CMenB 1 to 6 months apart at their last two study visits. These vaccines are approved for use in the UK, but are not routinely given to teenagers in this country. Samples are collected from the participants’ throats to compare rates of MenB carriage before and after getting the MenB vaccine. Teenagers have three study visits over 12 to 18 months and all visits take place within schools.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
1. Royal Alexandra Children's Hospital (UK)
2. Bristol Children's Vaccine Centre (UK)
3. Public Health Wales (UK)
4. Health Protection Scotland (UK)
5. St Mary's Hospital (UK)
6. Maidstone Hospital (UK)
7. Royal Manchester Children's Hospital (UK)
8. University of Nottingham Health Service (UK)
9. Churchill Hospital (UK)
10. Southampton General Hospital (UK)
11. St George's, University of London (UK)
12. Stepping Hill Hospital (UK)
13. Wrightington Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2017 to May 2021
Who is funding the study?
1. Department of Health (UK)
2. Pfizer (UK)
Who is the main contact?
Emma Plested
Trial website
Additional identifiers
EudraCT number
2017-004609-42
ClinicalTrials.gov number
Protocol/serial number
37350
Study information
Scientific title
Evaluating the effect of immunisation with group B meningococcal vaccines on meningococcal carriage
Acronym
Study hypothesis
Teenagers and young children are at increased risk of diseases such as meningitis and blood poisoning due to bacteria called meningococcus. Although these diseases can be serious, the meningococcus bacteria are ‘carried’ in the back of the throat of 1 in 10 teenagers without causing any symptoms. Most meningococcal disease in teenagers is due to Meningitis B (also known as MenB). The aim of this study is to find out whether immunising teenagers with vaccines against MenB can reduce the number of teenagers carrying these bacteria in their throat. This would be important because it could mean that teenage MenB immunisation would not only help protect teenagers against these potentially deadly diseases, but also that babies, children and older adults are less likely to be exposed to the bacteria. In short, immunising teenagers with a MenB vaccine might mean lower rates of meningococcal disease across all ages.
Ethics approval
South Central – Berkshire B Research Ethics Committee, 02/03/2018, ref: 18/SC/0055
Study design
Non-randomised; Both; Design type: Prevention, Vaccine, Cross-sectional
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Vaccination against meningitis
Intervention
Vaccines are randomly allocated by the project statistician on a site by site basis. Sites remain assigned to one vaccine group only for the duration of the study. Two types of MenB vaccine are used: 4CMenB (also known as Bexsero) and MenB-fHBP (also known as Trumenba). Participants in this study will either get two doses of 4CMenB or MenB-fHBP given 6 months apart at their first two study visits, or two doses of 4CMenB 1 to 6 months apart at their last two study visits. These vaccines are approved for use in the UK, but are not routinely given to teenagers in this country. The two doses of MenB vaccine will be given by IM injection into the deltoid by trained research nurses/doctors within the school setting. Oropharyngeal samples are collected from teenager’s throats to compare rates of MenB ‘carriage’ in teenagers before and after getting a MenB vaccine. Teenagers have three study visits, over 12 to 18 months and all visits would be held within schools. The follow up is 13 months for group 1 + 2 and up to 18 months for group 3.
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measure
Rates of carriage prevalence of any of meningococci genogroup B, C, W , X and Y before and after immunisation in both immunisation cohorts, compared with unimmunised controls; Timepoint(s): End of the study
Secondary outcome measures
Rates of carriage prevalence of particular Neisseria before and after immunisation in both immunisation cohorts, compared with controls, specifically:
1. Serogroup B meningococci
2. Hyper-invasive meningococcal strains
3. All meningococcal strains
4. Other Neisseria species
5. Meningococci of other non B serogroups and capsule null meningococci
6. Meningococci expressing antigens contained in 4CMenB and MenB-fHBP
The difference in acquisition of carriage of all N. meningitidis over a 12-month period in both immunised cohorts compared to unvaccinated participants
Overall trial start date
01/10/2017
Overall trial end date
31/05/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female, aged 16-18 years attending year 12 (or equivalent) at one of the participating 6th form colleges in England, Scotland and Wales
2. Participant is willing and able to give informed consent for participation
3. In the Investigator’s opinion, is able and willing to comply with all trial requirements.
4. Willing to have bacterial isolates from throat swabs stored for future research in ethically approved studies
5. Willing to allow his or her General Practitioner to be contacted to confirm vaccination status if necessary
Participant type
All
Age group
Child
Gender
Both
Target number of participants
Planned Sample Size: 24000; UK Sample Size: 24000
Total final enrolment
24048
Participant exclusion criteria
1. Evidence of a course of either 4CMenB or MenB-fHBP in the past (documentation or self-report)
2. History of anaphylaxis to any component of 4CMenB or MenB-fHBP
3. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participants ability to participate
4. Participant is known to be pregnant
Recruitment start date
19/03/2018
Recruitment end date
22/12/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Alexandra Children's Hospital
BSUHT
Eastern Road
East Sussex
Brighton
BN2 5BE
United Kingdom
Trial participating centre
Bristol Children's Vaccine Centre
Level 6
Education and Research Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
Trial participating centre
Public Health Wales
4th Floor, Number 2 Capital Quarter
Tyndall Street
Cardiff
CF10 4BZ
United Kingdom
Trial participating centre
Health Protection Scotland
4th Floor, Meridian Court
5 Cadogan Street
Glasgow
G2 6QE
United Kingdom
Trial participating centre
St Mary's Hospital
Praed St
London
W2 1NY
United Kingdom
Trial participating centre
Research and Development Department
Above Breast Care Centre – First floor
Maidstone Hospital
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Trial participating centre
Paediatric Research Team
5th Floor
Royal Manchester Children's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom
Trial participating centre
University of Nottingham Health Service
University Park
Derby Rd
Nottingham
NG7 2QW
United Kingdom
Trial participating centre
Oxford Vaccine Group
CCVTM
Churchill Hospital
Oxford
OX3 7LE
United Kingdom
Trial participating centre
Research & Development
The Lantern centre
Vicarage Lane
Fulwood
Preston
PR2 8DW
United Kingdom
Trial participating centre
University Hospital Southampton NHS Foundation Trust
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Trial participating centre
St George's, University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
Trial participating centre
Research and Innovation
Room F08, Pinewood House
Stockport NHS Foundation Trust
Stepping Hill Hospital
Stockport
SK2 7JE
United Kingdom
Trial participating centre
Clinical Trials Unit
Wrightington Hospital
Hall Lane
Appley Bridge
WN6 9EP
United Kingdom
Funders
Funder type
Government
Funder name
Department of Health; Grant Codes: PR-R18-0117-21001
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pfizer UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication of the results in a high impact peer reviewed journal as soon after the completion of the project as possible.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/05/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2020 protocol in https://pubmed.ncbi.nlm.nih.gov/33093030/ (added 26/10/2020)