Babies Born Early Antibody Response to Men B Vaccination: BEAR Men B

Prematurity Clinical Trial

— BEAR Men B  

Official title:

Babies Born Early Antibody Response to Men B Vaccination: A Phase IV Multicentre Randomised Study to Evaluate the Primary and Booster Immune Responses in UK Preterm Infants Receiving Routine Immunisations and Incorporating a Three Dose Versus a Two Dose Schedule of 4CMenB (Bexsero®) for Primary Immunisation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125616
• Other study ID #: 16.0247
• Secondary ID: 2017-001487-38
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2017
• Est. completion date: August 28, 2020

Study information

• Verified date: November 2020
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the UK, babies receive their vaccinations according to a standard schedule, irrespective of their gestation at birth. This policy is designed so that all babies are protected as early as possible from vaccine preventable diseases such as polio, diphtheria, tetanus, rotavirus, pertussis (whooping cough), Haemophilus influenzae type B, pneumococcal disease and now meningococcal B disease. The 4CMenB vaccination (Bexsero®) was added to the UK schedule in September 2015 and there has been no research looking at whether the vaccine gives the same protection to babies born early as it does to those born at term. The Investigators want to compare two different schedules of 4CMenB and see if one gives better protection to babies born prematurely. It is possible that an extra 4CMenB dose (i.e. three doses in early infancy instead of two) will offer better protection for premature babies. This is what the Investigators are trying to find out through this study.

Description:

This will be an open label, phase IV study. After appropriate consent, 132 premature infants born at <35 weeks gestation (i.e. up to 34 weeks and 6 days), 50% <30 weeks gestation (i.e. up to 29 weeks and 6 days) will be randomised to 1 of 2 4CMen B schedules either at 2,4 and 12 months or 2,3,4 and 12 months. Babies will remain in the study for around 12 months, from recruitment to 13 months of age. All visits can be performed at the participant's home or in clinic, depending on the preference of the parents and study team.

Blood samples will be obtained at 5 months of age (post primary sample), 12 months (persistence sample) and 13 months (post booster sample). Reactogenicity and safety will be assessed by caregiver completion of a 7-day diary after each vaccine dose. Inpatients will be monitored for cardiorespiratory events for 72 hours after vaccination by healthcare staff and this information will be collected on the CRF. This will include details of oxygen saturations, heart rate, respiratory rate and details of any episodes of desaturation, bradycardia or apnoea. Particular emphasis will be placed on rates, timing and intensity of fever and other adverse reactions in the first 24 hours after vaccination, because this remains a cause of great concern amongst neonatologists.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: August 28, 2020
• Est. primary completion date: September 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Weeks to 11 Weeks

Eligibility

Inclusion Criteria:

• Premature infant born at <35 weeks gestation

• No contraindications to vaccination according to the 'Green Book'

• Willing and able to comply with study procedures

• Written informed consent

Exclusion Criteria:

• Contraindication to vaccination according to the Green Book

• Life-limiting congenital abnormality or condition

• Prior diagnosis of an immunodeficiency syndrome

• Considered unlikely to complete expected follow up until the end of the study

Related Conditions & MeSH terms

• Meningococcal Disease
• Meningococcal Infections
• Premature Birth
• Prematurity
• Vaccination

Intervention

Biological:
• 4CMenB Vaccine
The infants will receive an intramuscular injection of the 4CMenB vaccine at 2 months
• 4CMenB Vaccine
The infants will receive an intramuscular injection of the 4CMenB vaccine at 3 months
• 4CMenB Vaccine
The infants will receive an intramuscular injection of the 4CMenB vaccine at 4 months
• 4CMenB Vaccine
The infants will receive an intramuscular injection of the 4CMenB vaccine at 12 months

Locations

Country	Name	City	State
United Kingdom	St Georges University Hospital NHS Foundation Trust	Tooting	London

Sponsors (4)

Lead Sponsor	Collaborator
St George's, University of London	GlaxoSmithKline, MeningitisNow, Public Health England

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hSBA GMT	hSBA GMT one month after completing primary immunisations for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA	Tested in each infant at 5 months of age (1 month after completion of primary vaccinations)
Primary	hSBA proportions	hSBA proportions = 1:4, one month after completing primary immunisations for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA.	Tested in each infant at 5 months of age (1 month after completion of primary vaccinations)
Secondary	Reactions within 7 days	The percentage of infants experiencing fever, local reactions and non-febrile systemic reactions within the 7 days following each vaccine dose	Assessed in each infant for the 7 days following vaccination
Secondary	Cardiorespiratory status for 72 hours following vaccination	The percentage of inpatients experiencing change / deterioration in cardiorespiratory status within the 72 hours following each vaccine dose	Assessed in all infants in hospital for 72 hours following vaccination
Secondary	Suspicion of sepsis in 7 days following vaccination	The percentage of infants investigated for sepsis and commenced on antibiotics within 7 days of vaccination	Assessed in all infants in the 7 days following vaccination
Secondary	Fever and/or suspicion of sepsis in the 28 days following vaccination	The percentage of infants who experience fever and/or are investigated for sepsis and commenced on antibiotics within 28 days of vaccination	Assessed in all infants in the 28 days following vaccination
Secondary	Serious adverse events	The percentage of infants who experience a serious adverse event at any point within the study	Assessed in all infants at the conclusion of the study
Secondary	Persistence of hSBA GMTs	hSBA GMTs at 12 months of age (pre booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA	Assessed in all infants at 12 months of age
Secondary	Persistence of hSBA proportions =1:4	hSBA proportions =1:4, at 12 months of age (pre booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA	Assessed in all infants at 12 months of age
Secondary	Booster response: hSBA GMTs	hSBA GMTs at 13 months of age (post booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA;	Assessed in all infants at 13 months of age
Secondary	Booster response: hSBA proportions =1:4	hSBA proportions =1:4, at 13 months of age (post booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA.	Assessed in all infants at 13 months of age

External Links

•   Meningococcal: the green book, chapter 22