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Study on the Impact of Vaccination With a Conjugate Vaccine on Meningococcal Carriage

NCT01119482 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33000

Last updated 2013-04-19

No results posted yet for this study

Summary

Meningococcal disease occurs throughout the world but attack rates in the Sahelian and sub-Sahelian regions of Africa - the African meningitis belt - are many times higher than those seen in any other part of the world. During 2009, over 70,000 meningitis cases and 3,200 deaths were reported in Nigeria, Niger, and Chad alone.

In 2001, a public private partnership between WHO and PATH was created, the Meningitis Vaccine Project (MVP). The MVP set out to develop an affordable meningococcal serogroup A conjugate vaccine (MenAfriVac™) for use in the African meningitis belt. This was successfully achieved, and the new vaccine, produced by the Serum Institute of India (SII), was granted a licence in 2009 for international export. The vaccine dossier was submitted to WHO for prequalification at the beginning of 2010. Introduction through mass vaccination is planned in three African Meningitis belt countries in 2010 (Burkina Faso, Mali and Niger). The implementation of MenAfriVac will be the responsibility of the local Ministry of Health, with the support of the World Health Organization.

It is anticipated that this vaccine will be deployed in other countries of the meningitis belt in 2011. This vaccine should provide high levels of direct protection to immunised individuals but, as for serogroup C conjugate vaccines in the United Kingdom, a greater public health impact will be achieved if carriage and transmission of the infection are also prevented.

The London School of Hygiene \& Tropical Medicine (LSTHM) is coordinating the African Meningococcal Carriage Consortium (MenAfriCar). One of the primary objectives of the MenAfriCar project is to evaluate the impact of the new conjugate vaccine on meningococcal carriage and transmission of serogroup A meningococci in Mali, Niger and Chad. A community-based prospective, pre- and post intervention, observational study will be conducted. MenAfriCar will also help to develop research capacity in the participating African countries.

Conditions

Interventions

BIOLOGICAL

MenAfriVac™

Children, adolescents and adults aged 1 to 29 years old will receive a single intramuscular injection of the meningococcal serogroup A conjugate vaccine .

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Maria C Nascimento, MD, PhD · London School of Hygiene and Tropical Medicine

  • Brian Greenwood, MD · London School of Hygiene and Tropical Medicine

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • Chad
  • Mali
  • Niger

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 NCT01119482 on ClinicalTrials.gov