Condition category
Infections and Infestations
Date applied
12/03/2018
Date assigned
14/03/2018
Last edited
14/03/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Scientific

Primary contact

Mrs Emma Plested

ORCID ID

Contact details

Oxford Vaccine Group
University of Oxford
CCVTM
Churchill Hospital
Headington
Oxford
OX3 7LE
United Kingdom

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

Specialty: Infectious diseases and microbiology, Primary sub-specialty: Vaccines; UKCRC code/ Disease: Infection/ Other bacterial diseases

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 measures

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

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

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

01/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Alexandra Children's Hospital
BSUHT Eastern Road East Sussex
Brighton
BN2 5BE

Trial participating centre

Bristol Children's Vaccine Centre
Level 6 Education and Research Centre Upper Maudlin Street
Bristol
BS2 8AE

Trial participating centre

Public Health Wales
4th Floor, Number 2 Capital Quarter Tyndall Street
Cardiff
CF10 4BZ

Trial participating centre

Health Protection Scotland
4th Floor, Meridian Court 5 Cadogan Street
Glasgow
G2 6QE

Trial participating centre

St Mary's Hospital
Praed St
London
W2 1NY

Trial participating centre

Research and Development Department
Above Breast Care Centre – First floor Maidstone Hospital Hermitage Lane
Maidstone
ME16 9QQ

Trial participating centre

Paediatric Research Team
5th Floor Royal Manchester Children's Hospital Oxford Road
Manchester
M13 9WL

Trial participating centre

University of Nottingham Health Service
University Park Derby Rd
Nottingham
NG7 2QW

Trial participating centre

Oxford Vaccine Group
CCVTM Churchill Hospital
Oxford
OX3 7LE

Trial participating centre

Research & Development
The Lantern centre Vicarage Lane Fulwood
Preston
PR2 8DW

Trial participating centre

University Hospital Southampton NHS Foundation Trust
Southampton General Hospital Tremona Road
Southampton
SO16 6YD

Trial participating centre

St George's, University of London
Cranmer Terrace
London
SW17 0RE

Trial participating centre

Research and Innovation
Room F08, Pinewood House Stockport NHS Foundation Trust Stepping Hill Hospital
Stockport
SK2 7JE

Trial participating centre

Clinical Trials Unit
Wrightington Hospital Hall Lane
Appley Bridge
WN6 9EP

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials and Research Governance (CTRG)
Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

corporate

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes