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Investigating Meningococcal Vaccines in Adults

NCT02398396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-10-27

No results posted yet for this study

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

Interventions

BIOLOGICAL

4CMenB (Bexsero®) - Novartis Vaccines and Diagnostics

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)

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-11-30
Completion
2019-06-13

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02398396 on ClinicalTrials.gov