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Investigating the Immune Response to 4CMenB in Infants

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: NCT02080559
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : October 19, 2018
Sponsor:
Collaborators:
Public Health England
Imperial College London
Novartis Vaccines
European Commission
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE February 17, 2014
First Posted Date  ICMJE March 6, 2014
Last Update Posted Date October 19, 2018
Actual Study Start Date  ICMJE July 21, 2014
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
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. [ Time Frame: 13 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigating the Immune Response to 4CMenB in Infants
Official Title  ICMJE A Randomised, Descriptive, Open Label, Study Exploring the Relationship Between Gene Expression Signatures With Reactogenicity and Immunogenicity Following Vaccination With Serogroup B Meningococcal Vaccine (4CMenB)
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.

Detailed Description

The incidence of meningococcal disease is 0.2-14 per 100,000 in industrialized countries. In England and Wales, during the period 2005-2010, there were 900-1300 cases annually. Disease is commonest in infants, young children and adolescents and case fatality is high at 8-10%.

Until recently there were no licensed vaccines against serogroup B meningococcal disease, although vaccines against epidemic strains of MenB have been used in several countries.

Unfortunately, 4CMenB is associated with significant reactogenicity. This is presumably related to the presence of various bacterial surface components present in the outer membrane vessicles (OMVs), including lipopolysacchride (LPS), which are capable of activating the innate immune response. The host pathways responsible for reactogenicity to OMV vaccines, and indeed to other vaccines, are not yet established, and the relationship between reactogenicity and immunogenicity is not clear.

This study will provide information about pathways and mechanisms of immunity and may identify gene expression signals which can be used in future vaccine design and evaluation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Meningitis
Intervention  ICMJE Biological: 4CMenB
0.5ml IM
Other Name: Bexsero
Study Arms  ICMJE
  • Experimental: 4CMenB - Test group
    Administered at 2, 4 and 12 months of age
    Intervention: Biological: 4CMenB
  • Active Comparator: 4CMenB - control group
    Given at 5, 7 and 13 months of age
    Intervention: Biological: 4CMenB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2018)
187
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2014)
160
Actual Study Completion Date  ICMJE April 27, 2018
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Any other condition which, in the opinion of the investigator, may interfere with the ability to fulfil study requirements (this may include plans to move house and language comprehension).
  • No internet access for the duration of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Weeks to 12 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02080559
Other Study ID Numbers  ICMJE OVG2012/05 EUCLIDS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE
  • Public Health England
  • Imperial College London
  • Novartis Vaccines
  • European Commission
Investigators  ICMJE
Principal Investigator: Andrew J Pollard, PhD Oxford Vaccine Group, University of Oxford
PRS Account University of Oxford
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP