Cuban Meningococcal Vaccine VA-MENGOC-BC:30 Years of Use and Future Potential.

Every year, meningococcal infection by Neisseria meningitidis causes over 500,000 cases and 85,000 deaths in the world, with 20% of survivors suffering sequelae. In Cuba its incidence in 1980 reached 5.9 cases per 100,000 population; about 80% of cases were serogroup B, prompting health authorities to declare meningococcal disease the country's main public health problem. Several provinces reported over 120 cases per 100,000 children aged < 1 year, overwhelmingly serogroup B. At that time, no vaccines existed with proven efficacy against N. meningitidis serogroup B, nor was there a vaccine candidate that could be successful in the short term. By 1989, researchers in Havana had developed a Cuban meningococcal B and C vaccine, VA-MENGOC-BC, the world's first against serogroup B meningococcal disease. Its efficacy of 83% was demonstrated in a prospective, randomized, double-blind, placebo-controlled field study. Vaccine production used vesicle or proteoliposome technology for the first time. The same year, the World Intellectual Property Organization awarded its gold medal to the main authors of the VA-MENGOC-BC patent. The vaccine was used in a mass vaccination campaign and later included in Cuba's National Immunization Program, with a cumulative impact on incidence of serogroup B meningococcal disease greater than 95% (93%-98%). Mass, systematic vaccination shifted the spectrum of meningococcal strains in healthy asymptomatic carriers and strains circulating among population groups toward nonvirulent phenotypes. The disease ceased to be a public health problem in the country. VA-MENGOC-BC is the most widely applied vaccine against serogroup B meningococcal disease in the world. Over 60 million doses have been administered in Latin America. In several countries where it has been applied, in which strains other than the vaccine-targeted strains circulate, VA-MENGOC-BC has demonstrated effectiveness against all (55%-98% in children aged < = 4 years and 73%-100% in children aged > 4 years). The vaccine and its proteoliposome technology have had an impact and continue to have potential, not only for meningococcal disease, but also for development of other vaccines and adjuvants.KEYWORDS Neisseria meningitidis, meningococcal disease, meningo-coccal vaccine, biotechnology, pharmaceutical industry, bacterial menin-gitis, meningococcal meningitis, immunization, vaccination, Cuba.