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Novartis meningitis B vaccine effective in infants

Bexsero could be first vaccine available to offer broad coverage for three strains of the disease

Novartis's meningitis B vaccine Bexsero has demonstrated it is effective in infants when used as part of a regular vaccine schedule, according to a new study.

The findings, published in the Journal of the American Medical Association, show the vaccine stimulated an immune response against three strains of the meningococcus B bacterium - H44/76, 5/99, NZ98/254.

Over 1,800 infants were involved in the phase IIb trial, which gives further evidence of Bexsero's potential to be the first vaccine that can offer broad coverage against meningitis B and also be used as part of a regular vaccine schedule.

The trial of Bexsero saw the vaccine meet its primary endpoints of immunogenicity when given with or without routine infant vaccines to healthy infants, and of safety and tolerability of three doses when given concomitantly with routine infant vaccines.

In participants receiving Bexsero, with or without routine vaccines, at two, four and six months, the immungenicity endpoint (using the human serum bactericidal antibody (hSBA) assay with a titer >= 1:5) was achieved in 99 per cent of cases involving the strains 44/76 and 5/99.

The same figure was achieved when Bexsero was taken at two, three and four months along with routine vaccines.

When up against the NZ98/254 strain of meningitis B, Bexsero demonstrated the required effectiveness in 79 per cent of patients when taken at two, four and six months with routine vaccines, and 87 per cent of patients when taken at the same regularity without routine vaccines.

For patients receiving Bexsero at two, three and four months along with routine vaccines, 81 per cent achieved the primary endpoint level of effectiveness.

The routine vaccines were 7-valent pneumococcal glycoconjugate vaccine and a combined diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B and Haemophilus influenzae type b vaccine.

Dr Matthew Snape, a consultant in vaccinology and general paediatrics at the University of Oxford, UK, said the development of a vaccine against meningitis B would be an “enormous step forward” in the prevention of meningitis.

He said: "This study provides important data on how well infants' immune systems respond to this new MenB vaccine when given in a variety of schedules. This information is vital when considering how the vaccine could be incorporated into different immunisation regimens around the world."

As well as Bexsero, Novartis already markets the meningitis vaccine Menveo, which is used to protect against meningitis groups A, C, W135 and Y. It was approved in Europe in March, 2010.

9th February 2012

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