Sponsor study identifier
interventional
15
1 country
1
Study Start
April 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
Actual (reported)Study Completion
June 13, 2019
Actual (reported)This study will be an open label, exploratory immunogenicity study conducted by the Oxford Vaccine Group, University of Oxford. This study will investigate the breadth of protective activity of serum anti-FHbp antibody responses of adults immunized with 4CMenB (Bexsero®) vaccine as well as investigating the nature of the B-cell and T-cell responses induced by vaccination. The investigators aim to enroll 15 to 20 healthy adults aged 18 to 60, who will be immunized with two doses of 4CMenB (Bexsero®) two months apart according to the licensed schedule. Blood samples will be obtained at baseline and after each dose of vaccine.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 13, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 20, 2015
Actual (reported)March 25, 2015
Actual (reported)April 2015
Date type not reportedThis date has not been verified as actual or estimated.
November 2015
Actual (reported)June 13, 2019
Actual (reported)To characterise the breadth of protective activity of serum anti-FHbp antibody responses of adults immunised with 4CMenB (Bexsero) vaccine
As measured by IgG antibody responses to FHbp as measured by serum bactericidal activity against a panel of genetically diverse meningococcal strains
3 months
To investigate the nature of the B-cell response that supports the induction of antibody with functional activity following vaccination with 4CMenB
3 months
To investigate the nature of the T-cell response that supports the induction of antibody with functional activity following vaccination with 4CMenB
3 months
Determine whether adults immunised with 4CMenB develop serum IgG and IgM antibodies to human FH
3 months
Exploratory immunology to investigate the role of anti-FHBp antibodies in meningococcal immunity
3 months
4CMenB vaccine (Bexsero - Novartis Vaccines and Diagnostics) 0.5ml intra-muscularly; two doses, administered 2 months apart. Each dose of vaccine contains recombinant Neisseria meningitidis group B NHBA fusion protein (50 micrograms); recombinant Neisseria meningitidis group B NadA protein (50 micrograms); recombinant Neisseria meningitidis group B FHbp fusion protein (50 micrograms) and Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 (25 micrograms measured as amount of total protein containing the PorA P1.4)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Giuntini S, Lujan E, Gibani MM, Dold C, Rollier CS, Pollard AJ, Granoff DM. Serum Bactericidal Antibody Responses of Adults Immunized with the MenB-4C Vaccine against Genetically Diverse Serogroup B Meningococci. Clin Vaccine Immunol. 2017 Jan 5;24(1):e00430-16. doi: 10.1128/CVI.00430-16. Print 2017 Jan.
15 participants (actual enrollment reported by the registry).
First Submitted
March 20, 2015
First Posted
March 25, 2015
Study Start
April 2015
Date type not reportedThis date has not been verified as actual or estimated.
Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients
Contact the study team to confirm eligibility.
Primary Completion
November 2015
Actual (reported)Study Completion
June 13, 2019
Actual (reported)Last Updated
October 27, 2021
Record last verified: 2018-10
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Source: ClinicalTrials.gov.
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