Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03125616
Recruitment Status : Active, not recruiting
First Posted : April 24, 2017
Last Update Posted : July 29, 2020
Sponsor:
Collaborators:
GlaxoSmithKline
MeningitisNow
Public Health England
Information provided by (Responsible Party):
St George's, University of London

Brief 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.

Condition or disease Intervention/treatment Phase
Prematurity Vaccination Meningococcal Disease Biological: 4CMenB Vaccine Phase 4

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be an open label, phase IV study.
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : September 2, 2019
Estimated Study Completion Date : September 30, 2020


Arm Intervention/treatment
Active Comparator: Standard UK 4CMenB vaccine
4CMenB (Bexsero®) vaccination at 2 and 4 months and a booster at 12 months .
Biological: 4CMenB Vaccine
The infants will receive an intramuscular injection of the 4CMenB vaccine at 2 months
Other Name: Bexsero

Biological: 4CMenB Vaccine
The infants will receive an intramuscular injection of the 4CMenB vaccine at 4 months
Other Name: Bexsero

Biological: 4CMenB Vaccine
The infants will receive an intramuscular injection of the 4CMenB vaccine at 12 months
Other Name: Bexsero

Experimental: Additional 4CMenB Vaccine
4CMenB (Bexsero®) vaccination at 2, 3 and 4 months and a booster at 12 months.
Biological: 4CMenB Vaccine
The infants will receive an intramuscular injection of the 4CMenB vaccine at 2 months
Other Name: Bexsero

Biological: 4CMenB Vaccine
The infants will receive an intramuscular injection of the 4CMenB vaccine at 3 months
Other Name: Bexsero

Biological: 4CMenB Vaccine
The infants will receive an intramuscular injection of the 4CMenB vaccine at 4 months
Other Name: Bexsero

Biological: 4CMenB Vaccine
The infants will receive an intramuscular injection of the 4CMenB vaccine at 12 months
Other Name: Bexsero




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Weeks to 11 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125616


Locations
Layout table for location information
United Kingdom
St Georges University Hospital NHS Foundation Trust
Tooting, London, United Kingdom, SW17 0QT
Sponsors and Collaborators
St George's, University of London
GlaxoSmithKline
MeningitisNow
Public Health England
Investigators
Layout table for investigator information
Principal Investigator: Paul Heath, MBBS St George's, University of London
Additional Information:
Layout table for additonal information
Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT03125616    
Other Study ID Numbers: 16.0247
2017-001487-38 ( EudraCT Number )
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by St George's, University of London:
Prematurity
Vaccination
Additional relevant MeSH terms:
Layout table for MeSH terms
Meningococcal Infections
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs