The Meningitis Vaccine Project (MVP) is a partnership between the World Health Organization and PATH. The goal of the project is to eliminate epidemic meningitis as a public health problem in sub-Saharan Africa through the development, testing, licensure and widespread use of meningococcal conjugate vaccines.

For the last century sub-Saharan Africa has suffered repeated epidemics of meningococcal meningitis. These epidemics have been clustered in the so-called "meningitis belt," a vast area that stretches from Senegal to Somalia. Epidemics have occurred every 8-12 years, and the human toll from these epidemics has been enormous-the 1996 epidemic alone resulted in over 250 000 reported cases and 25 000 deaths. Over the last 20 years control of epidemic meningitis has emphasized surveillance and reactive mass immunizations with meningococcal polysaccharide (PS) vaccines. Because PS vaccines are ineffective in children less than two years, provide limited protection for older age groups and have no effect on carriage these emergency mass vaccinations campaigns must be repeated on a regular basis. This sub-optimal strategy is a major burden for the health services of countries within the meningitis belt.

More specifically, MVP is developing a serogroup A meningococcal conjugate (MenA conjugate) vaccine to be widely used in 1 to 29 year olds to control serogroup A disease, which accounts for most meningococcal epidemics in Africa. The vaccine will also be available for use in the Expanded Program on Immunization.

Ensuring that this new conjugate vaccine is affordable is a priority for MVP. African public health officials have repeatedly emphasized the importance of price as a limiting factor in the sustainable use of new vaccines in Africa. In order to assure a low-priced, high-quality vaccine, MVP is working with three groups: SynCo Bio Partners B.V. in Amsterdam for supply of meningococcal polysaccharide A (one of the two main components of the vaccine); Serum Institute of India Limited in Pune (SIIL) for supply of tetanus toxoid (the second main component of the vaccine) and vaccine manufacturing; and the Center for Biologics Evaluation and Research of the United States Food and Drug Administration (CBER) for development of a conjugation technology that chemically links the two main components of the vaccine to produce a conjugate product. CBER transferred its conjugation technology to SIIL, and SIIL agreed to manufacture a MenA conjugate vaccine at a target price of $US 0.40 per dose.

Clinical lots of the MenA conjugate vaccine were prepared in 2004. A Phase I clinical study was successfully completed in India in December 2005 and showed that the vaccine was safe and immunogenic. Phase II trials in The Gambia and Mali will start in September 2006.

MVP's strategy of developing a low-cost vaccine through facilitating and coordinating numerous public-private partnerships demands a high level of management responsibilities and accountability from the project team. However, the low-cost vaccine resulting from this approach will help ensure accessibility to countries of the meningitis belt in Africa and widespread sustainable uptake of the vaccine. Broad and sustained uptake is critical for achieving public health impact and meeting the goal of the project. In addition, this approach has the potential for providing a new model for vaccine development that could facilitate the introduction of other "orphan" vaccines whose primary markets are low-income countries in the developing world.

Address

Dr. F Marc Laforce,
Director - Meningitis Vaccine Project,
PATH, 13 Chemin Du Levant,
Ferney 01210, France.
Telephone : +33 (0)4 50 28 00 49
Fax : +33 (0)4 50 28 04 07