Plain English Summary
Background and study aims
Meningitis (infection of the lining of the brain) and septicaemia (blood poisoning) have many causes; an important cause in the UK is a bacteria called Meningococcus. Vaccination protects against some forms of Meningococcus by encouraging the body to make antibody to the bacteria - a chemical which helps fight the bacteria if it is encountered. In the UK babies are vaccinated according to the same schedule whether they are born early (preterm) or on time, but there are concerns that preterm babies may not respond as strongly to their vaccinations - this may result in less protection. In 2015 a new vaccine, the Men B vaccine, was introduced. There have been no studies done to determine whether this will work as well in preterm babies compared with term babies. This study will compare responses made by babies who are vaccinated according to two different schedules. This could help doctors make decisions about what programme should be followed for preterm babies.
Who can participate?
Premature babies born before 35 weeks of pregnancy
What does the study involve?
Parents are approached about the study and provided with information. If parents wish their baby to take part in the study they are asked to sign a consent form. Babies are randomly allocated to receive their Men B vaccine (Bexsero) according to one of two schedules - they either receive two doses of Men B vaccine at 2 and 4 months or three doses of Men B vaccine at 2, 3 and 4 months alongside their routine vaccinations given according to the UK schedule. Parents are asked to complete a diary card for one week following each set of vaccinations. Blood sampling is performed at 5, 12 and 13 months. These blood samples are to measure the amount of antibody (a protein which fights infection) following Men B vaccination to compare the two schedules to see if one gives better protection to babies born preterm.
What are the possible benefits and risks of participating?
If, after the booster vaccination, the baby is found to have a low response to vaccination they are offered an additional booster vaccine. This study involves the administration of vaccines which are given as part of the routine vaccination schedule. Whilst all vaccinations carry a very small risk of adverse reactions this is not greater for those taking part in the study compared with those receiving the vaccinations as part of routine care and all vaccines given as part of the study are given by members of staff trained in vaccine administration and the management of adverse reactions. The study involves blood samples being obtained which can be associated with discomfort and bruising, but these samples will be collected by staff who are trained in obtaining blood samples from babies and local anaesthetic cream can be used for the blood sampling.
Where is the study run from?
1. St George’s Hospital (UK)
2. John Radcliffe Hospital (UK)
3. Churchill Hospital (UK)
4. Norfolk and Norwich University Hospital (UK)
5. Queen Alexandra Hospital (UK)
6. Southampton General Hospital (UK)
7. Royal Cornwall Hospital (UK)
When is the study starting and how long is it expected to run for?
June 2016 to March 2020
Who is funding the study?
1. GlaxoSmithKline
2. Meningitis Now
Who is the main contact?
1. Dr Anna Calvert
acalvert@sgul.ac.uk
2. Jennifer Stuart
jstuart@sgul.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Anna Calvert
ORCID ID
http://orcid.org/0000-0002-1922-6208
Contact details
St George’s
University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
+44 (0)2087253887
acalvert@sgul.ac.uk
Type
Scientific
Additional contact
Ms Jennifer Stuart
ORCID ID
Contact details
Paediatric Infectious Diseases Research Team
St George's
University of London
Cranmer Terrace
Tooting
SW17 0RE
United Kingdom
+44 (0)2087255382
jstuart@sgul.ac.uk
Additional identifiers
EudraCT number
2017-001487-38
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS: 34643
Study information
Scientific title
Babies born Early Antibody Response to Men B vaccination: BEAR Men B
Acronym
BEAR Men B
Study hypothesis
To investigate the antibody response in preterm infants to two different schedules of Men B vaccine.
Ethics approval
Approved 17/05/2017, Yorkshire & The Humber- Sheffield Research Ethics Committee (Room 001, Jarrow Business Centre, Rolling Mill Road, Jarrow, Tyne and Wear, NE32 3DT, UK; Tel: +44 (0)207 1048082; Email: nrescommittee.yorkandhumber-sheffield@nhs.net), ref: 17/YH/0150
Study design
Randomised; Interventional; Design type: Prevention, Vaccine
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
See additional files
Condition
Meningitis
Intervention
Babies will be randomised in a 1:1 ratio to receive two doses (at 2 and 4 months) or three doses (at 2, 3 and 4 months) of Men B vaccine (Bexsero) in their primary vaccination series. All babies will receive their other routine vaccinations according to the UK schedule which will include a booster dose of Men B vaccine (Bexsero) at the age of 12 months.
Intervention type
Biological/Vaccine
Phase
Not Applicable
Drug names
Primary outcome measure
Antibody response to Men B vaccination assessed using serum bactericidal antibody (SBA) assays performed on samples collected at 5 months (post primary), 12 months (pre-booster) and 13 months (post booster):
1. hSBA GMTs 1 month after completion of primary immunisations for relevant Bexsero antigens: fHbp, NadA and PorA
2. hSBA proportions ≥1:4, at 1 month after completion of primary immunisations for relevant Bexsero antigens: fHbp, NadA and PorA
Secondary outcome measures
Local and systemic effects of the vaccine collected using a diary card completed for the 7 days following each set of vaccinations:
1. The percentage of infants presenting with fever, local reactions and non-febrile systemic reactions within the 7 days following each Bexsero® vaccine dose
2. The percentage of inpatients who have a change/deterioration in cardiorespiratory status within the 72 hours following each Bexsero® vaccine dose
3. The percentage of infants investigated for sepsis and commenced on antibiotics within 7 days of Bexsero® vaccination
4. hSBA GMTs at 12 months of chronological age (pre booster) for relevant Bexsero® antigens: fHbp, NadA and PorA
5. hSBA proportions ≥1:4, at 12 months of chronological age (pre booster) for relevant Bexsero® antigens: fHbp, NadA and PorA
6. hSBA GMTs at 13 months of chronological age (4-6 weeks post booster) for relevant Bexsero® antigens: fHbp, NadA and PorA
7. hSBA proportions ≥1:4, at 13 months of age (post booster) for relevant Bexsero® antigens: fHbp, NadA and PorA
Overall trial start date
01/06/2016
Overall trial end date
01/03/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Premature infant born at <35 weeks gestation
2. No contraindications to vaccination according to the ‘Green Book’
3. Willing and able to comply with study procedures
4. Written informed consent
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
Planned Sample Size: 132; UK Sample Size: 132
Participant exclusion criteria
1. Contraindication to vaccination according to the Green Book
2. Life-limiting congenital abnormality or condition
3. Prior diagnosis of an immunodeficiency syndrome
4. Considered unlikely to complete expected follow up until the end of the study
Recruitment start date
01/08/2017
Recruitment end date
01/10/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St George’s Hospital
Blackshaw Road
Tooting
SW17 0QT
United Kingdom
Trial participating centre
John Radcliffe Hospital
Headley Way
Headington
OX3 9DU
United Kingdom
Trial participating centre
Centre for Clinical Vaccinology and Tropical Medicine
Churchill Hospital
Oxford
OX3 7LE
United Kingdom
Trial participating centre
Norfolk and Norwich University Hospital
Colney Lane
Colney
NR4 7UY
United Kingdom
Trial participating centre
Queen Alexandra Hospital
Cosham
Portsmouth
PO6 3LY
United Kingdom
Trial participating centre
Southampton General Hospital
Tremona Rd
Southampton
SO16 6YD
United Kingdom
Trial participating centre
Royal Cornwall Hospital
Treliske
Truro
TR1 3LQ
United Kingdom
Funders
Funder type
Government
Funder name
GlaxoSmithKline
Alternative name(s)
GlaxoSmithKline plc., GSK
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Funder name
Meningitis Now
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The researchers intend to publish in a high-impact peer reviewed journal by early 2021.
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
01/03/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN14943533_PROTOCOL_V2.1_02Aug2018.docx Uploaded 10/07/2019
- ISRCTN14943533_PIS_v2.0_04Dec2017.docx Uploaded 10/07/2019