1805

Scientists describe meningococcal disease for the first time during an outbreak in Geneva, Switzerland.

1887

Neisseria meningitidis is identified as the causative agent of bacterial meningococcal meningitis.

1909

Major epidemic outbreaks are observed in Africa, especially in the sub-Saharan region, where they continue to wreak havoc.

1966

Polysaccharide vaccines are developed in response to epidemics of meningitis in industrialized countries, but their effectiveness remains limited in Africa.

Early 1990s

Conjugate vaccines better adapted to Africa are field-tested in Niger and Gambia, but the projects are discontinued in the mid-1990s.

1996

More than 20,000 people die during the largest meningococcal meningitis epidemic ever recorded in the sub-Saharan meningitis belt.

2000

The World Health Organization (WHO) thinks of a focused plan to develop and introduce conjugate meningitis vaccines to fight and eliminate epidemics in Africa.

In April, delegates from African and Eastern Mediterranean countries, multilateral organizations, vaccine manufacturers, and the scientific community gather at WHO and conclude that:

• Meningococcal disease is a major public health problem.
• Current strategies that focus on epidemic response or preparedness are insufficient.
• Development of a conjugate vaccine for Africa is a high priority.
• MVP offers a unique opportunity to eliminate meningococcal epidemics and strengthen immunization systems in the region.

Following in-depth discussions with vaccine manufacturers in 2000, plans are drawn for the creation of MVP via a collaboration between WHO and PATH.

2001

30 May: The Gates Foundation awards PATH and WHO US$ 70 million for the development of meningitis vaccines in Africa.

30 July: Dr. F. Marc LaForce is appointed as the Project Director for MVP.

July-December:

• MVP establishes the MVP-Ferney Voltaire office in France.
• MVP develops the strategy for the development and licensing of meningococcal conjugate vaccines and begins discussions with African partners on these issues.
• MVP establishes enhanced surveillance activities in three meningitis belt countries.
• MVP approaches major pharmaceutical companies to discuss development of conjugate meningococcal vaccines for use in Africa.

2002

January–June

• After extensive negotiations between MVP and pharmaceutical companies both parties conclude that it will not be possible for the major vaccine manufacturers in the industrialized world to serve as the locus for vaccine production of a monovalent serogroup A meningococcal conjugate (MenA conjugate) vaccine. MVP starts exploring alternative strategies for the production of such a vaccine.
• MVP identifies suppliers of serogroup A meningococcal polysaccharide (PsA) and tetanus toxoid (TT), the two components necessary for the development of the MenA conjugate vaccine.
• MVP identifies potential collaborators for the development and transfer of the conjugation process.
• MVP selects a vaccine manufacturer in the developing world for scale-up production, lyophilization, packaging, storage, and distribution of the vaccine.

July–December

• MVP analyzes epidemiological data collected during the 2002 epidemic season and develops a strategy in the event serogroup W135 emerges as a key cause of epidemics
• MVP designs a product development plan (pharmaceutical, clinical, regulatory strategy) for the MenA conjugate vaccine. The plan is submitted to and approved by expert groups.
• Suppliers produce purified PsA and TT.
• MVP participates in numerous international conferences and multiplies contacts with African health experts.
• In December, MVP organizes the first meeting of the MVP Project Advisory Group (PAG) in Abuja, Nigeria.
• MVP develops its visual identity with the MVP logo; it launches the meningvax.org website and creates an information kit.

2003

January–June

Vaccine Development

• The MVP scientific team and MVP consultants support the work of the suppliers of PsA and TT on improving their purification methods.
• The MVP scientific team plans and defines a timeline for pharmaceutical operations, including training, technology transfer, clinical batches preparation, and scale-up.
• The company selected by MVP to mass manufacture the vaccine equips its conjugation facilities.

  Clinical Activities

• MVP selects a company to implement the preclinical toxicology studies for the candidate MenA conjugate vaccine.
• The MVP clinical team selects the US Centers for Disease Control (CDC) and the Manchester Public Health Laboratory Service (PHLS) to implement all serologic studies.
• MVP identifies potential contract research organizations (CROs) to work on data management, statistical analysis, and monitoring.
• In March, MVP holds a meeting in Dakar, Senegal, with representatives from African vaccine research sites. Participants review MVP clinical protocols and make presentations about their site experience and capabilities. As a result, MVP identifies and visits potential sites for Phase II and Phase III studies in Africa.
• The MVP clinical team finalizes the Phase I protocol for the study MenA conjugate vaccine and polishes up the synopses for Phase II clinical studies.
• The MVP clinical team develops long-term timelines and plans for Phases I, II, and III clinical studies for the MenA conjugate vaccine.

  Surveillance Activities

• The regional surveillance unit in Ouagadougou, Burkina Faso, led by the MVP surveillance officer, compiles and distributes weekly detailed reports of the meningitis situation in five countries during the epidemic season. The reports, which contain comprehensive bacteriologic data, indicate that the dominant strain during 2003 was serogroup A, although W135 was widely distributed in Niger and Burkina Faso.

Epidemiological Research

• Epidemiologist Marie-Pierre Préziosi starts documenting the expected benefits from widespread vaccination with a monovalent serogroup A meningococcal conjugate vaccine in Africa.

  Communication and Advocacy

• The MVP director develops relationships and contacts in Africa by making several visits to meningitis belt countries in February and March during the epidemic season.
• MVP increases knowledge and awareness about meningitis and the project by linking its website, www.meningvax.org, to other websites devoted to African news, health, and science, both in French and in English.
• MVP distributes bilingual print materials at presentations and conferences, and it actively engages in media outreach.

July–December

Vaccine Development

• The MVP scientific team and collaborating institutions select a serogroup A Neisseria meningitidis strain that gives higher yields than the previous strain and still meets all European Phamarcopoeia standards.
• Following an Expert Panel meeting in Washington in November, MVP narrows down the number of partners who can develop and transfer a conjugation technology for the project. The first preaward agreements are signed in December.

  Clinical Activities

• The MVP clinical team continues its visits to potential field sites for Phase II studies in Africa and contacts additional sites. At each visit, MVP staff review site capacity in terms of their ability to conduct clinical studies, and they meet with the site team and representatives of local and national health authorities.
• The MVP clinical team completes the final draft protocol for the Phase I clinical study and circulates the draft for peer review.
• MVP selects four CROs to work on data management, statistical analysis, and study monitoring. Preaward agreements are signed with some of the CROs.
• As far as regulatory activities are concerned, MVP builds its capacity in the field of vaccine licensure and prequalification by holding preliminary discussions with the WHO prequalification team.

Surveillance Activities

• MVP continues to provide technical and financial support to the WHO Enhancing Meningococcal Disease Surveillance efforts in the African meningitis belt.
• With support from MVP, the WHO Multi-Disease Surveillance Center (MDSC) in Ouagadougou completes a comprehensive meningitis surveillance report for the 2003 epidemic season based on a dramatic increase in quantity and quality of surveillance information. In turn, increased surveillance information improves response and enhances understanding of responsible pathogens.

Epidemiological Research

• MVP epidemiologist Marie-Pierre Préziosi develops a full research plan and scope of work and finalizes the design of the research database with assistance from WHO.
• Dr. Préziosi carries on her work on a comprehensive literature review of meningococcal meningitis in sub-Saharan Africa. In addition to compiling information on vaccine use from country dossiers and vaccine manufacturers, she visits meningitis belt countries and establishes relations with research centres that are part of the WHO meningitis collaborating network.

Communication and Advocacy

• MVP makes project presentations at several meetings, including the Strategic Advisory Group of Experts (SAGE) meeting in Geneva, Switzerland; the West Africa Health Organization Expert meeting in Banjul, Gambia; and the Network for Education and Support in Immunization (NESI) meeting in Saly, Senegal.
• The MVP director and the MVP clinical team meet with African experts and public health officials at WHO/AFRO in Ouagadougou, Lome (Togo), and in countries that might be selected to host clinical studies for the candidate MenA conjugate vaccine.
• MVP organizes its first press conference in Ouagadougou in November.
• MVP continues its work on a contact database for increased outreach and an in-house electronic and hard copy library for enhanced support to MVP scientific staff.
• MVP develops a strategic communication plan for communication and advocacy for 2003-2007.

2004

MVP publishes its first quarterly newsletter!

For a quarter-by-quarter review of MVP's progress in vaccine and clinical development, meningococcal disease surveillance, epidemiological research, communication, and vaccine introduction, click here.

For the latest MVP newsletter, click here.

Looking ahead

The four key strategic areas on which MVP will focus in the future include:

• Vaccine development: Ensuring the development, clinical evaluation, and licensing of conjugate meningococcal vaccines for sub-Saharan Africa;
• Research and surveillance: Better availability of up-to-date, comprehensive information about meningococcal meningitis and current meningitis epidemic prevention strategies in target countries;
• Vaccine roll-out and distribution: Introducing serogroup A meningococcal conjugate vaccines in meningitis belt countries,
• Communications, advocacy, and resource mobilization: Providing information to 'the meningitis community' and global health community about MVP and raising adequate funds for ongoing activities in research and surveillance and to ensure that conjugate meningococcal vaccines reach the greatest number of people.