Investigating the Immune Response to 4CMenB in Infants

NCT02080559 | Completed Phase 4 DMC

• 1 other identifier: OVG2012/05 EUCLIDS
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

This randomised, open-label, single-centre, descriptive study aims to investigate gene expression (i.e what genes are 'switched on' and 'off') following vaccination with 4CMenB and to relate this to vaccine reactions and to immune response. 160 healthy Caucasian infants aged 8-12 weeks (at time of first visit) who have not yet received their routine infant immunisations will be recruited. Participation in the study will be limited to to Caucasian infants (defined as having two Caucasian parents). This is so that baseline variability in gene expression data which is to some degree affected by ethnicity is reduced. Participants will be randomised to either a 'test' group or 'control' group depending on what 4CMenB schedule they receive, with 80 infants in each. All participants will receive the usual paediatric immunisations according to the UK national immunisation schedule. In addition, participants in the test groups will receive 4CMenB at 2, 4 and at 12 months while those in the control groups will receive the same vaccine at 5, 7 and 13 months. Blood samples will be taken from each infant at specified time points before and after vaccination to address the objectives of the study. In addition, oro-pharyneal swabs will be obtained around different vaccination timepoints to investigate the effect of 4CMenB vaccination on the oro-pharyngeal Neisseria microbiome.

Conditions

Meningitis

Outcome Measures

Primary Outcomes (1)

• Gene expression in whole blood at 4hr, 24hr, 3d and 7d time points following 4CMenB and routine infant vaccination given at 2, 4 and 12 months.

  This is a descriptive study that aims to identify what genes are 'turned on' or 'turned off' following vaccination with 4CMenB and routine vaccines.

  13 months

Study Arms (2)

4CMenB - Test group

EXPERIMENTAL

Administered at 2, 4 and 12 months of age

Biological: 4CMenB

4CMenB - control group

ACTIVE COMPARATOR

Given at 5, 7 and 13 months of age

Biological: 4CMenB

Interventions

4CMenB BIOLOGICAL

0.5ml IM

Also known as: Bexsero

4CMenB - Test group; 4CMenB - control group

Eligibility Criteria

• Age: 8 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants of two Caucasian parents (self-defined by parent) born between 37 and 42 weeks of gestation aged 8-12 weeks at time of first visit
• Parent or legal guardian willing and able to comply with the requirements of the protocol and have internet access for the duration of the study.
• Parent/legal guardian who have given informed consent for their child's participation in the study

You may not qualify if:

• Non-Caucasian infants
• Children of parents who are on the delegation log for this study
• Parent/ legal guardian under the age of 18
• History of invasive meningococcal B disease
• Previous vaccination with meningococcal serogroup B vaccine
• History of being a household contact with a case of confirmed bacterial meningitis
• Prior administration of any vaccine or planned administration of any vaccine not specified in the study protocol, with the exception of Hepatitis B vaccine and Influenza vaccines (which can be given 14 days before or after study vaccines), or BCG (which can be administered 28 days before or after study vaccines)
• Prior or planned receipt of any other investigational vaccine or drug
• Confirmed or suspected immunodeficiency
• A family history of congenital or hereditary immunodeficiency, or maternal HIV
• Receipt of more than 1 week of immunosuppressants or immune modifying drugs (e.g. oral prednisolone \>0.5ml/kg/day or intravenous glucocorticoid steroid).
• History of allergy to any component of the vaccine
• Major congenital defects or serious chronic illness
• History of any neurologic disorders or seizures
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period

Sponsors & Collaborators

• University of Oxford: lead
• Public Health England: collaborator
• Imperial College London: collaborator
• Novartis Vaccines: collaborator
• European Commission: collaborator

Study Sites (1)

Oxford Vaccine Group, Centre for Clininal Vaccinology & Tropical Medicine

Oxford, OX3 7LE, United Kingdom

Location

Related Publications (1)

• O'Connor D, Pinto MV, Sheerin D, Tomic A, Drury RE, Channon-Wells S, Galal U, Dold C, Robinson H, Kerridge S, Plested E, Hughes H, Stockdale L, Sadarangani M, Snape MD, Rollier CS, Levin M, Pollard AJ. Gene expression profiling reveals insights into infant immunological and febrile responses to group B meningococcal vaccine. Mol Syst Biol. 2020 Nov;16(11):e9888. doi: 10.15252/msb.20209888.

  PMID: 33210468 DERIVED

MeSH Terms

Conditions

Meningitis

Interventions

4CMenB vaccine

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Study Officials

• Andrew J Pollard, PhD

  Oxford Vaccine Group, University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: March 6, 2014
• Study Start: July 21, 2014
• Primary Completion: June 1, 2016
• Study Completion: April 27, 2018
• Last Updated: October 19, 2018

Record last verified: 2018-02

Locations

GB (1)