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Understanding the Immune Response to Meningitis Vaccines

NCT00901940 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2014-12-05

No results posted yet for this study

Summary

The purpose of the study is to evaluate and compare the immune response to two vaccines against 4 related bacteria: meningococcal serogroups A, C, W-135 and Y. These bacteria can cause meningitis and /or septicaemia (blood poisoning). The two vaccines are a protein-polysaccharide conjugate vaccine (MenACWY)and a meningococcal plain polysaccharide vaccine(MenACWY PS). Both vaccines are licensed and are currently used for travellers to areas with a high incidence of invasive meningococcal disease. However, plain polysaccharide vaccines are known to be poorly immunogenic in children and they do not stimulate immunological memory, apart from the serogroup A component. In contrast, a protein-polysaccharide conjugate vaccine against meningococcal serogroups A, C, W-135 and Y has been found to be immunogenic in infants and to be able to induce immunological memory.

The proposed study is a single centre, open-label, randomised, controlled study in 150 healthy adults aged 18-70 years. The participants will be given either 2 injections of the meningococcal protein-polysaccharide conjugate vaccine one month apart, or one injection of the meningococcal plain polysaccharide vaccine followed one month later with an injection of the meningococcal conjugate vaccine. Blood samples will be collected before immunisation and at several time points following immunisations to evaluate the level of meningococcal specific antibody induced by two different vaccination regimes. The data derived from the study will be relevant in determining which of these vaccines should be used in preference in travellers who are receiving immunisation against meningococcal disease before travelling to high risk areas. Additionally, a number of scientific questions regarding the nature of the immune response to the two vaccines (specifically looking at the white blood cells responsible for producing antibodies, known as B cells) and the role of genetic variations in influencing the vaccine recipient's immune response will be addressed in the study.

Conditions

Interventions

BIOLOGICAL

Meningococcal (Groups A, C, Y and W-135) Conjugate

2 x 0.5 mL dose

BIOLOGICAL

Meningococcal polysaccharide A, C, Y and W135 and Menveo

1 x 0.5 mL dose of ACWY Vax, 1 x 0.5 mL dose of Menveo

Sponsors & Collaborators

  • Novartis Vaccines

    collaborator INDUSTRY

  • University of Oxford

    lead OTHER

Principal Investigators

  • Andrew Pollard, FRCPCH, PhD · University of Oxford, Department of Paediatrics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00901940 on ClinicalTrials.gov