Neisseria meningiditis is a leading cause of meningococcal disease and is endemic in many parts of the world. Polysaccharide (PS) vaccines for types A and C are effective in adults but not in infants. Covalently linking protein to the polysaccharide converts the antigen to one which is T cell dependent and is immunogenic in infants. We propose to synthesize protein- Ps conjugate vaccines for N. meningiditis A and C using novel chemistries to couple the protein to the Ps, either with or without a spacer, and over a wide range of protein to polysaccharide rations. Adult and neonatal nice will be immunized and antibody and bactericidal titers determined. We will evaluate whether the presence of unconjugated protein is detrimental or beneficial to the efficacy of the vaccine and whether it needs to be removed from the final vaccine preparation. The process of eliminating unconjugated protein from Ps-coupled protein as is currently done is expensive, reduces product yields and may be unnecessary. To test this, we will remove unconjugated protein using a proprietary and low cost method that we have developed. The chemistries and technology developed in this proposal can be applied to other protein-Ps conjugate vaccines and could result in significant savings.

Proposed Commercial Applications

Neisseria meningiditis is a leading cause of meningococcal disease and is endemic and pandemic in certain arts of the world with consequent significant economic impact. Our proposed conjugate vaccines for types A and C would be less expensive to synthesize. They would be available for use in the developing world.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43AI043707-01
Application #
2712392
Study Section
Special Emphasis Panel (ZRG5-TMP (04))
Project Start
1998-07-01
Project End
1999-06-30
Budget Start
1998-07-01
Budget End
1999-06-30
Support Year
1
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Virion Systems, Inc.
Department
Type
DUNS #
802674192
City
Rockville
State
MD
Country
United States
Zip Code
20850