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

NCT01119482 | Completed Phase 4 DMC

• 1 other identifier: LSHTM_5698
• Study Type: interventional
• Target: 33,000
• Locations: 3 countries
• Sites: 3

Brief 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

Meningitis

Keywords

Serogroup A meningococcal vaccine; meningococcal carriage; incidence; prevalence

Outcome Measures

Primary Outcomes (1)

• Meningococcal carriage

  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.

  Prevalence of meningococcal carriage at six months after vaccination

Secondary Outcomes (1)

• Meningococcal carriage

  Prevalence of meningococcal carriage at 18 months after vaccination

Study Arms (1)

Vaccination

OTHER

Healthy volunteers before and after vaccination

Biological: MenAfriVac™

Interventions

MenAfriVac™ BIOLOGICAL

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

Also known as: Meningococcal serogroup A conjugate vaccine

Vaccination

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Bill and Melinda Gates Foundation: collaborator
• Wellcome Trust: collaborator

Study Sites (3)

Centre de Support en Sante Internationale (CSSI)

Ndjanema, Chad

Location

Center for Vaccine Development, Mali

Bamako, Bamako, Mali

Location

Centre de Recherche Médicale et Sanitaire

Niamey, Niger

Location

Related Publications (1)

• Diallo K, Gamougam K, Daugla DM, Harrison OB, Bray JE, Caugant DA, Lucidarme J, Trotter CL, Hassan-King M, Stuart JM, Manigart O, Greenwood BM, Maiden MCJ. Hierarchical genomic analysis of carried and invasive serogroup A Neisseria meningitidis during the 2011 epidemic in Chad. BMC Genomics. 2017 May 22;18(1):398. doi: 10.1186/s12864-017-3789-0.

  PMID: 28532434 DERIVED

MeSH Terms

Conditions

Meningitis

Interventions

MenAfriVac

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Study Officials

• Maria C Nascimento, MD, PhD

  London School of Hygiene and Tropical Medicine

  STUDY DIRECTOR

• Brian Greenwood, MD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: May 7, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 19, 2013

Record last verified: 2013-04

Locations

NI (1); CH (1); MA (1)