Men B vaccination in preterm infants: a comparison of two schedules
| ISRCTN | ISRCTN14943533 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14943533 |
| EudraCT/CTIS number | 2017-001487-38 |
| Secondary identifying numbers | CPMS: 34643 |
- Submission date
- 31/07/2017
- Registration date
- 10/07/2019
- Last edited
- 20/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
St George’s, University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
 ORCID ID |
0000-0002-1922-6208 |
|---|---|
| Phone | +44 (0)2087253887 |
| acalvert@sgul.ac.uk |
Scientific
Paediatric Infectious Diseases Research Team
St George's, University of London
Cranmer Terrace
Tooting
SW17 0RE
United Kingdom
| Phone | +44 (0)2087255382 |
|---|---|
| jstuart@sgul.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Prevention, Vaccine |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | ISRCTN14943533_PIS_v2.0_04Dec2017.docx |
| Scientific title | Babies born Early Antibody Response to Men B vaccination: BEAR Men B |
| Study acronym | BEAR Men B |
| Study objectives | To investigate the antibody response in preterm infants to two different schedules of Men B vaccine. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/06/2016 |
| Completion date | 01/03/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Planned Sample Size: 132; UK Sample Size: 132 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2017 |
| Date of final enrolment | 01/10/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Tooting
SW17 0QT
United Kingdom
Headington
OX3 9DU
United Kingdom
Oxford
OX3 7LE
United Kingdom
Colney
NR4 7UY
United Kingdom
Portsmouth
PO6 3LY
United Kingdom
Southampton
SO16 6YD
United Kingdom
Truro
TR1 3LQ
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Mr Subhir Bedi
Cranmer Terrace
London
SW17 0RE
England
United Kingdom
"ROR" |
https://ror.org/040f08y74 |
|---|
Funders
Funder type
Government
Government organisation / For-profit companies (industry)
- Alternative name(s)
- GlaxoSmithKline plc., GSK plc., GSK
- Location
- United Kingdom
Government organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The researchers intend to publish in a high-impact peer reviewed journal by early 2021. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v2.0 | 04/12/2017 | 10/07/2019 | No | Yes |
| Protocol file | version V2.1 | 02/08/2018 | 10/07/2019 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN14943533_PROTOCOL_V2.1_02Aug2018.docx
- Uploaded 10/07/2019
- ISRCTN14943533_PIS_v2.0_04Dec2017.docx
- Uploaded 10/07/2019
Editorial Notes
20/04/2021: The intention to publish date was changed from 01/03/2021 to 01/06/2021.
10/07/2019: Uploaded protocol Version V2.1, 02 August 2018 (not peer reviewed). The participant information sheet has been uploaded.
31/07/2017: Trial's existence confirmed by the NIHR.
