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

This study has been completed.
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Wellcome Trust
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01119482
First received: April 21, 2010
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Meningitis
Biological: MenAfriVac™
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Impact of Vaccination With a Serogroup A Meningococcal Conjugate Vaccine on Carriage of Serogroup A Meningococci in Mali and Niger

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Meningococcal carriage [ Time Frame: Prevalence of meningococcal carriage at six months after vaccination ] [ Designated as safety issue: No ]
    Cross-sectional surveys will be conducted in approximately 5,000 age stratified subjects before and 6 and 18 months after vaccination with the meningococcal serogroup A conjugate vaccine to estimate the prevalence of meningococcal carriage. During each cross-sectional survey all household members in contact with an identified serogroup A carrier will be included in a household follow up study to investigate the impact of vaccination on the rates of acquisition of meningococcal carriage.


Secondary Outcome Measures:
  • Meningococcal carriage [ Time Frame: Prevalence of meningococcal carriage at 18 months after vaccination ] [ Designated as safety issue: No ]
    Cross-sectional surveys will be conducted in approximately 5,000 age stratified subjects before and 6 and 18 months after vaccination with the meningococcal serogroup A conjugate vaccine to estimate the prevalence of meningococcal carriage. During each cross-sectional survey all household members in contact with an identified serogroup A carrier will be included in a household follow up study to investigate the impact of vaccination on the rates of acquisition of meningococcal carriage.


Enrollment: 33000
Study Start Date: May 2010
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Vaccination
Healthy volunteers before and after vaccination
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 .
Other Name: Meningococcal serogroup A conjugate vaccine

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults or children whose parent or guardian give consent to participate in the study
  • Adults or children who do not have a serious acute or chronic illness

Exclusion Criteria:

  • lack of consent given by an adult or the parent or guardian of a potentially eligible study child
  • Adults or children who have a serious acute or chronic illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119482

Locations
Chad
Centre de Support en Sante Internationale (CSSI)
Ndjanema, Chad
Mali
Center for Vaccine Development, Mali
Bamako, Mali
Niger
Centre de Recherche Médicale et Sanitaire
Niamey, Niger
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Bill and Melinda Gates Foundation
Wellcome Trust
Investigators
Study Director: Maria C Nascimento, MD, PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Brian Greenwood, MD London School of Hygiene and Tropical Medicine
  More Information

No publications provided

Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01119482     History of Changes
Other Study ID Numbers: LSHTM_5698
Study First Received: April 21, 2010
Last Updated: April 18, 2013
Health Authority: Mali: Ministry of Health
Niger: Institutional Review Board
Chad: Ministry of Health

Keywords provided by London School of Hygiene and Tropical Medicine:
Serogroup A meningococcal vaccine
meningococcal carriage
incidence
prevalence

Additional relevant MeSH terms:
Meningitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 01, 2014