Meningitis

The bacterial pathogen Neisseria meningitidis is a major cause of meningitis. Most disease is caused by five serogroups: A, B, C, Y and W-135. Recently, the successful development of a vaccine for meningitis C has dramatically reduced the overall incidence of meningitis, now only leaving serogroup B (NmB) without a protective vaccine. Difficulties arise because the serogroup B polysaccharide coat structure is also found in humans. Consequently, unlike for other serogroups, a vaccine cannot be developed which targets the bacteria’s coating. In addition, most countries have multiple strains of NmB in circulation. Ideally, there would be a single vaccine, with the necessary breadth of protection against NmB, irrespective of strain or even better, a single vaccine across all the serogroups of Neisseria meningitidis.

The bacteria may infect the meninges around the brain and spinal cord. It can also lead to septicaemia. Typically:

• Up to 10% of infections result in death
• 15-30% of infections lead to long term disability, including deafness, amputations and mental retardation.

Cluster outbreaks only account for around 5% of cases (though a particularly severe outbreak started in New Zealand in 1991 and has led to around 300 deaths pa). Around 10% of the populations (but 25% of teenagers) carry the bacteria in the pharynx and for unknown reason, a percentage (typically 0.5-1.5 per 100,000 of the population) develop meningitis. Incidence is very high in infants.

IV antibiotics may clear infection and avoid disability if initiated early. However, only non-specific symptoms are initially evident and infection progresses rapidly - typically death is within 24 -36 hours of first symptoms. In infants, it can be particularly difficult to identify symptoms of meningitis early. In the UK, the mortality rate is around 300 pa.

Cuba and New Zealand have developed products for the specific MenB sub-types prevalent in their respective countries but (e.g.) the UK has 6 common sub-types and there are no vaccines available.

With ImmBioVax technology offering a powerful new approach for a vaccine, with broad, cross-strain protection, ImmBio is collaborating with the meningitis research group within the School of Medical Sciences at the University of Bristol. In addition, with particular expertise, including capability for large scale cGMP production, assays and immunology, ImmBio has entered into a co-development agreement with the Health Protection Agency (“HPA”) to develop the vaccine, MenBioVax.

• Single vaccine for all N.meningitidis serogroups and serotypes
  
  • Uniquely protective for N.meningitidis B serotypes
• Protective and safe in infants from 3 months onward

ImmBio’s product, MenBioVax has two key benefits:

1. Broad Protection
   Using vaccines enriched in the addresses both pathogen and human diversity. Strain classification of Neisseria meningitis is often based on capsular composition (serogroup) while MenBioVax contains a broad range of the pathogen’s proteins hence is not serogroup-specific. Therefore while the major unmet need is against NmB, MenBioVax may ultimately offer a simple single vaccine against all serogroups and serotypes.
2. No Need to Identify Protective Antigen and Delivery Method
   Many vaccine approaches are dependent on the identification of protective antigen(s) and having done so, need to then identify how to achieve appropriate presentation. MenBioVax obviates these issues, cost-effectively.