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Completed

NCT Number: NCT03125616

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

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.

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Key information

Conditions

Prematurity Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases and Pregnancy Complications Gram-Negative Bacterial Infections Infections Meningococcal Disease Meningococcal Infections Neisseriaceae Infections Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases Vaccination

Age range

7 week–11 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St Georges University Hospital NHS Foundation Trust

Tooting, London, SW17 0QT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4CMenB vaccine

Biological

The infants will receive an intramuscular injection of the 4CMenB vaccine at 2 months

Other names: Bexsero

Primary outcomes

  1. hSBA GMT

    Time frame: Tested in each infant at 5 months of age (1 month after completion of primary vaccinations)

    hSBA GMT one month after completing primary immunisations for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA

  2. hSBA proportions

    Time frame: Tested in each infant at 5 months of age (1 month after completion of primary vaccinations)

    hSBA proportions ≥ 1:4, one month after completing primary immunisations for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA.

Secondary outcomes

  1. Reactions within 7 days

    Time frame: Assessed in each infant for the 7 days following vaccination

    The percentage of infants experiencing fever, local reactions and non-febrile systemic reactions within the 7 days following each vaccine dose

  2. Cardiorespiratory status for 72 hours following vaccination

    Time frame: Assessed in all infants in hospital for 72 hours following vaccination

    The percentage of inpatients experiencing change / deterioration in cardiorespiratory status within the 72 hours following each vaccine dose

  3. Suspicion of sepsis in 7 days following vaccination

    Time frame: Assessed in all infants in the 7 days following vaccination

    The percentage of infants investigated for sepsis and commenced on antibiotics within 7 days of vaccination

  4. Fever and/or suspicion of sepsis in the 28 days following vaccination

    Time frame: Assessed in all infants 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

  5. Serious adverse events

    Time frame: Assessed in all infants at the conclusion of the study

    The percentage of infants who experience a serious adverse event at any point within the study

  6. Persistence of hSBA GMTs

    Time frame: Assessed in all infants at 12 months of age

    hSBA GMTs at 12 months of age (pre booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA

  7. Persistence of hSBA proportions ≥1:4

    Time frame: Assessed in all infants at 12 months of age

    hSBA proportions ≥1:4, at 12 months of age (pre booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA

  8. Booster response: hSBA GMTs

    Time frame: Assessed in all infants at 13 months of age

    hSBA GMTs at 13 months of age (post booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA;

  9. Booster response: hSBA proportions ≥1:4

    Time frame: Assessed in all infants at 13 months of age

    hSBA proportions ≥1:4, at 13 months of age (post booster) for relevant 4CMenB (Bexsero®) antigens: fHbp, NadA and PorA.

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Collaborators

  • GlaxoSmithKline
  • MeningitisNow
  • Public Health England

Registry information

Official study 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.

Acronym: BEAR Men B

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Apr 24, 2017
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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