Strong Ph II data for Novartis' MenB vacc

Swiss drug major Novartis says that new mid-stage data on MenB, its investigational recombinant meningococcal group B vaccine, support its promise as the first potentially-broad coverage vaccine capable of protecting infants against the deadly disease.

According to new Phase II study results, which were presented at the European Society for Paediatric Infectious Diseases annual meeting, held in Graz, Austria, a series of three immunizations with the MenB vaccine starting at two months of age produced a protective immune response in infants, as evaluated by a biomarker of clinical protection. One month after the third dose, the percentage of subjects achieving a protective immune response against strains representing multiple antigens included in the Novartis MenB vaccine were 89%, 96% and 85%. A fourth dose given at 12 months also resulted in 100%, 98% and 93% of subjects achieving a protective immune response and was indicative of an immune memory response.

The vaccine contains multiple bacterial surface proteins that are believed to be found in most meningococcal B strains responsible for the disease globally, Novartis noted, adding that this strain is a leading cause of bacterial meningitis throughout the world, particularly among infants, accounting for 72% of meningococcal disease in Europe in 2006. "The prospect of one vaccine that protects infants worldwide against meningococcal serogroup B would be a key achievement in global disease prevention of our time," said Ray Borrow, head of the vaccine evaluation unit at the Health Protection Agency, UK.