Study on the Impact of Vaccination With a Conjugate Vaccine on Meningococcal Carriage (MenAfriCar)
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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 |
- 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.
- 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 |
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| 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 | |
| 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 May 16, 2013