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Development of a novel intranasal pneumococcal vaccine

The aim of this project is to develop a novel low-cost vaccine against pneumococcal disease that is suitable to be implemented in the emerging markets, using a new vaccine technology that allows intranasal delivery, low-cost vaccine production and broader protection.

Infections caused by Streptococcus pneumoniae can lead to invasive disease including sepsis, meningitis, and,most frequently, pneumonia; it is also a common cause of primarily mucosal diseases, such as acute otitis media and sinusitis. S. pneumoniae infections are a major cause of morbidity and mortality killing at least 1.6 million people every year including 1 million children. Most of them under the age of 5 years particularly in the developing countries. Pneumonia is by far the most common cause of pneumococcal death worldwide. Currently there are more than 90 known pneumococcal sub-types; the ten most common types account for approximately 62 percent of invasive disease worldwide. Antibiotics, particularly penicillin, are the current standard therapy. However, 40% of S. pneumoniae strains show resistance to the current antibiotics. This percentage is rapidly increasing due to overuse and misuse of antibiotics, making prevention of disease even more important. The World Health Organization (WHO) has recognized the need for better and broader vaccines to reduce disease related mortality. The development of safe, efficient and affordable pneumococcal vaccines is a matter of the highest priority. The aim of this project is to develop a prototype of a novel low-cost vaccine against Pneumococcal disease that can be administered intranasally and is suitable to be implemented in developing countries. The Laboratory of Pediatric Infectious Diseases of the Radboud University Nijmegen Medical Center (RUNMC) has strong expertise in the field of pneumococcal vaccine development and discovered new vaccine antigens using a genomic array foot printing (GAF) approach. The laboratory of pediatric infectious diseases has selected 5 candidate antigens that provide a better and broader (multivalent) protection against disease. Furthermore, these antigens allow intranasal delivery and low-cost vaccine production. In this project, the Drug Discovery Factory BV (DDF), Co-Vaccine BV, RUNMC and Xbrane Bioscience AB will join forces to develop this technology into an actual vaccine against Pneumococcal disease. DDF will guide the R&D programme ensuring the development of an actual commercial viable product. In this project a novel technique of Xbrane Bioscience AB to produce non-live carriers of antigens will be implemented to formulate the intranasal vaccine. This technology is based on so called Outer Membrane Vesicles (OMV). OMV’s are non-viable membrane vesicles that are naturally excreted by Salmonella bacteria. The surface of these particles resembles the surface of Salmonella bacteria and can be used as carriers of antigens in a vaccine. By inducing surface display of carefully selected antigens on Salmonella bacteria and subsequent shedding of OMV’s from these Salmonella bacteria, a perfect method for both production and delivery of antigens in a non-live vaccine is created. CoVaccine BV, a Dutch biotech company developing and exploiting ready-for-use adjuvants for human vaccines, will deliver the required adjuvant technology necessary for intranasal delivery of the antigens. The company has a proven track record in the development of adjuvant technologies for vaccines. In 2006 CoVaccine successfully licensed its CoVaccine HT adjuvant technology for use in pandemic influenza vaccines, and seasonal influenza vaccines in elderly to Protherics plc. / Nobilon. The unique cooperation within this project offers the unique opportunity to obtain a prototype of a high-quality vaccine against Pneumococcal disease that after successful clinical testing can be made available to millions of peolple worldwide. Therefore, the market potential is substantial. To make the vaccine available in Africa the consortium will join forces with the South African vaccine manufacturer The Biovac Institute once the vaccine is ready for market introduction after the project. It is important to note that the actual development of the vaccine formulation will take place in The Netherlands and Sweden. As such the core of the R&D work is performed at the EUREKA countries. However, in order to ensure that time to commercialization of a successful vaccine in Africa is as short as possible, Biovac will test the scalability manufacturing processes across all phases of the project. This public-private-partnership (PPP) will be involved in the testing and upscaling the production of the vaccine components. They will explore the feasibility to scale-up the vesicle production in their laboratories. The Biovac Institute is currently setting up large scale GMP production capacity to become the main vaccine provider in the South-African continent. Local vaccine production will further reduce production costs.
Acronym: 
PneumoVac
Project ID: 
7 200
Start date: 
01-02-2012
Project Duration: 
36months
Project costs: 
2 070 000.00€
Technological Area: 
Virus, Virology, Vaccines/ Antiobiotics / Bacteriology
Market Area: 
Pharmaceuticals/fine chemicals

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