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Meningococcal and Pneumococcal Conjugate Vaccine and Method of Using Same

Pneumococcal diseases are a major public health problem all over the world. The etiological agent, Streptococcus pneumoniae (the pneumococcus) is surrounded by a polysaccharide capsule. Differences in the composition of this capsule permit serological differentiation between about 90 capsular types, some of which are frequently associated with pneumococcal disease, others rarely. Invasive pneumococcal infections include pneumonia, meningitis and febrile bacteremia; among the common non-invasive manifestations are otitis media, sinusitis and bronchitis. At least 1 million children die of pneumococcal disease every year, most of these being young children in developing countries. Vaccination is the only available tool to prevent pneumococcal disease. The recent development of widespread microbial resistance to essential antibiotics underlines the urgent need for more efficient pneumococcal vaccines.

Meningococcal disease is a contagious bacterial disease caused by the meningococcus (Neisseria meningitidis). It is spread by person-to-person contact through respiratory droplets of infected people. There are 3 main clinical forms of the disease: the meningeal syndrome, the septic form and pneumonia. The onset of symptoms is sudden and death can follow within hours. In as many as 10-15% of survivors, there are persistent neurological defects, including hearing loss, speech disorders, loss of limbs, mental retardation and paralysis. Up to 5-10% of a population may be asymptomatic carriers. These carriers are crucial to the spread of the disease as most cases are acquired through exposure to asymptomatic carriers. Waning immunity among the population against a particular strain favors epidemics, as do overcrowding and climatic conditions such as dry seasons or prolonged drought and dust storms. The disease mainly affects young children, but is also common in older children and young adults. The disease occurs sporadically throughout the world with seasonal variations and accounts for a proportion of endemic bacterial meningitis. However, the highest burden of the disease is due to the cyclic epidemics occurring in the African meningitis belt.

With the burden of S. pneumoniae and N. meningitidis infection on the public health system at a global scale, it is desirable to have a single vaccine that is effective to prevent disease resulting from the infection of both pathogens. This application claims immunogenic compositions for inducing an immune response to two different microorganisms, S. pneumoniae and N. meningitidis. The application also claims conjugate vaccines comprising at least one N. meningitidis capsular polysaccharide conjugated to a recombinant pneumococcal protein.

Potential Commercial Applications:

Conjugate vaccine for the prevention and/or therapy of meningococcal and pneumococcal infections.

Competitive Advantages:

  • Rapid production time
  • Higher-yielding manufacturing method
  • Low manufacturing cost

Che-Hung Robert Lee
Stanley Tai

Intellectual Property:
U.S. Pat: No. 8,003,112 issued 2011-08-23
PCT Application No. PCT/US2010/031083
US Application No. 13/183,303
Related international patent applications filed

Licensing Contact:
Bill Ronnenberg, JD-MIP, MS
FDA Technology Transfer Program
10903 New Hampshire Ave.
Building WO1, Rm 4214
Silver Spring, MD 20993
Email: FDAInventionlicensing@fda.hhs.gov
Phone: 240-402-4561

OTT Reference No: E-2010-002
Updated: August 7, 2015