Understanding the Persistence of Immunity After MenC Vaccines

May 7, 2013 updated by: University of Oxford

An Observational Study Into the Maintenance of Seroprotection Against Meningococcal Serogroup C Disease Throughout Childhood Following a Single Dose of a Conjugated Meningococcal Serogroup C Vaccine Administered to Toddlers

Neisseria meningitidis occurs worldwide as endemic disease1 and is a major cause of invasive infections such as meningitis and septicaemia. Three protein-polysaccharide conjugate serogroup C meningococcal (MenC) vaccines were developed in the late 1990's and an accelerated programme of clinical trials in the UK led to licensure of these MenC vaccines in 1999 and these vaccines were introduced into the routine infant immunisation schedule at 2, 3 and 4 months. However, children who were aged 1-18 years in 2000 only received a single dose of a MenC conjugate vaccine during the mass immunisation campaign.

Previous studies have demonstrated rapid waning of MenC specific antibody concentrations and serum bactericidal antibody (SBA) titres following immunisation in young children. A cross-sectional review on rates of sero-protection against MenC disease in the UK has demonstrated that the majority of children who were immunised with a single dose of a MenC conjugate vaccine between the ages of 1-10 did not have protective titres of MenC SBA 7 years after the immunisation campaign. As this cohort of children reaches adolescence there is a risk of increased transmission of the organism and a resurgence of meningococcal disease in children who do not have protective levels of antibody. There is thus a need to conduct a study evaluating the changes in MenC SBA titres over time in children who received a single dose of a MenC vaccine in early childhood which is the main objective of this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 7LJ
        • Oxford Vaccine Group, University of Oxford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy children who participated in the U01-Td5I-303/ C01.183 study from 2001 to 2007 who will be aged 11 to 13 years in 2010, all of whom would have received a single dose of a MenC conjugate vaccine in 2000 as part of the nationwide immunisation campaign.

Description

Inclusion Criteria:

  • Participant whose parent is willing and able to give informed consent for participation in the study.
  • Participant who gives assent for participation in the study.
  • Male or Female, aged 11 to 13 years.
  • Known to be free from medical problems as determined by a medical history and clinical assessment
  • Participated in the University of Oxford clinical trial: U01-Td5I-303/ C01.183

Exclusion Criteria:

  • History of invasive meningococcal C disease
  • Any vaccination against MenC disease with the exception of a single dose in 2000 during the nationwide MenC immunisation campaign
  • Confirmed or suspected immunosuppressive or immunodeficient conditions, including human immunodeficiency virus (HIV) infection.
  • Major congenital defects or serious chronic illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MenC vaccinated healthy children
Children who received a single dose of a MenC conjugate vaccine at age 1-3 years 10 years earlier.
Procedure: Venepuncture
  1. Venepuncture and blood sample collection in 2010 in a sample of children who received a single dose of a MenC conjugate vaccine at age 1-3 years 10 years earlier.
  2. A booster dose of a MenC conjugate vaccine (optional).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with rSBA titres >1:8 (correlate of protection)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
MenC rSBA GMTs at all time points when sera is available after receiving a dose of MenC vaccine
Time Frame: 6 months
6 months
Percentage of children at each time point with MenC SBA titres >1:8
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Principal Investigator: Matthew Snape, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

May 19, 2010

First Posted (Estimate)

May 20, 2010

Study Record Updates

Last Update Posted (Estimate)

May 9, 2013

Last Update Submitted That Met QC Criteria

May 7, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OVG 2009/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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