Scientific challenges for the quality control and production of group C meningococcal conjugate vaccines.

Recommendations (formerly known as requirements) for meningococcal polysaccharide vaccines were adopted by the World Health Organisation (WHO) Expert Committee on Biological Standardisation in 1976 and amended in 1978 and 1981. In clinical studies, these vaccines have been shown to have efficacy of at least 90% and have proved to be highly effective in vaccination programmes. Nevertheless, their inability to elicit protective responses in young infants or to induce good immunological memory has prevented their implementation in national infant immunisation schedules. Following the successful introduction of the Haemophilus influenzae type b conjugate (Hib) vaccines, considerable progress has been made in the development of similar conjugate vaccines based on meningococcal group C capsular polysaccharide. Controlled clinical trials have demonstrated that they induce protective levels of antibodies to group C polysaccharide in all age groups and, as T-cell dependent antigens, induce immunological memory and affinity maturation of anti-capsular antibodies. Such vaccines have been shown to offer protective immunity following the introduction of group C conjugates in the UK. The World Health Organisation has produced recommendations for the production and control of these new vaccines.