Study on the Impact of Vaccination With a Conjugate Vaccine on Meningococcal Carriage (MenAfriCar)
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|ClinicalTrials.gov Identifier: NCT01119482|
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : April 19, 2013
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 or disease||Intervention/treatment||Phase|
|Meningitis||Biological: MenAfriVac™||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Vaccination With a Serogroup A Meningococcal Conjugate Vaccine on Carriage of Serogroup A Meningococci in Mali and Niger|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||June 2012|
Healthy volunteers before and after vaccination
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
- Meningococcal carriage [ Time Frame: Prevalence of meningococcal carriage at six months after vaccination ]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.
- Meningococcal carriage [ Time Frame: Prevalence of meningococcal carriage at 18 months after vaccination ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119482
|Centre de Support en Sante Internationale (CSSI)|
|Center for Vaccine Development, Mali|
|Centre de Recherche Médicale et Sanitaire|
|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|