Investigating Meningococcal Vaccines in Adults

NCT02398396 | Completed

• 1 other identifier: OVG 2014/12
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meningococcal Vaccines; Meningococcal Infections; Neisseria Meningitidis; Factor H-binding Protein, Neisseria Meningitidi

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• Exploratory immunology to investigate the role of anti-FHBp antibodies in meningococcal immunity

  3 months

Study Arms (1)

Open Label: 4CMenB (Bexsero®)

EXPERIMENTAL

Biological: 4CMenB (Bexsero®) - Novartis Vaccines and Diagnostics

Interventions

4CMenB (Bexsero®) - Novartis Vaccines and Diagnostics BIOLOGICAL

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)

Open Label: 4CMenB (Bexsero®)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years to 60 years inclusive on the day of first vaccination.
• To be in good health as determined by medical history, physical examination and clinical judgment of the investigators.
• Agree (in the Investigator's opinion) to comply with all study requirements
• Agree to allow his or her General Practitioner (and/or Consultant if appropriate), to be notified of participation in the study
• Agree to provide their National Insurance/Passport number for the purposes of TOPS registration and bank account information for the purpose of reimbursement for the duration of their participation.

You may not qualify if:

• Have any known or suspected impairment or alteration of immune function, resulting from, for example:
• Congenital or acquired immunodeficiency (including IgA deficiency)
• Human Immunodeficiency Virus (HIV) infection or symptoms/signs suggestive of an HIV-associated condition
• Autoimmune disease
• Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy.
• Chronic illness that could interfere with immunological function or donation of the required volumes of blood (e.g. cardiac or renal disease, diabetes, or auto-immune disorders).
• Receipt of a live vaccine within 4 weeks prior to vaccination or a killed vaccine within 7 days prior to vaccination.
• History of group B meningococcal vaccination
• Have received a dose of a meningococcal groups A, C, W, Y conjugate vaccine within 30 days of enrolment or wish to receive a dose of this vaccine during the study period.
• Plan to receive any vaccine other than the study vaccine within 4 weeks following vaccination.
• History of severe allergic reaction after vaccination or known hypersensitivity to any vaccine component
• History of meningococcal disease
• Receipt of blood, blood products, or plasma derivatives within the past 3 months.
• Recent significant blood donation (e.g., to the National Blood Service) within 8 weeks of enrolment, or plans to donate blood during the study period.
• Thrombocytopenia or any bleeding disorder.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 27847367 DERIVED

MeSH Terms

Conditions

Meningococcal Infections

Interventions

4CMenB vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: March 25, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: June 13, 2019
• Last Updated: October 27, 2021

Record last verified: 2018-10

Locations

GB (1)