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Regulation of Mucosal Immune Response to Systemic MenB Vaccine

NCT00774384 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-11-15

No results posted yet for this study

Summary

Meningitis or septicaemia (blood poisoning) caused by group B meningococcal infection (MenB) is an important cause of death and disability in the UK. Prevention through vaccination therefore remains a key public health priority. Research from national "meningitis" vaccine programmes against MenC, Hib and Streptococcus pneumoniae show us that their success is in part due to their ability to protect both the vaccinated and the unvaccinated, so-called herd immunity. This protection probably occurs by reducing carriage of these meningitis bacteria in the back of the throat (mucosal immunity). How this happens is poorly understood but our research shows that naturally acquired immunity (transient contact between the immune system and the meningococcus in the back of the throat without causing disease) may impact on this process. We believe that to develop a MenB vaccine that is able to cause mucosal immunity and prevent MenB carriage, it is important to understand the interaction between natural immunity and vaccination. In this study we propose to administer MenB vaccine to adults in order to investigate this process. Our findings will provide important insights into Men B immunity, inform the design of novel vaccine strategies and allow the rational testing of new vaccines as they become available.

Conditions

  • Meningococcal Infections

Interventions

BIOLOGICAL

NZ MenB OMV vaccine (NZ98/254)

3 doses by intramuscular injection

Sponsors & Collaborators

  • University of Bristol

    collaborator OTHER

  • Public Health England

    collaborator OTHER_GOV

  • Novartis Vaccines

    collaborator INDUSTRY

  • North Bristol NHS Trust

    collaborator OTHER

  • University Hospitals Bristol and Weston NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-11-30
Completion
2011-11-30

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 NCT00774384 on ClinicalTrials.gov