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PentaStaph™ (Staphylococcal Polysaccharide Conjugate and Toxoid Vaccine)
Vaccines therapies represent a new and innovative approach in broadening the available clinical tools against the global health problem of community and healthcare-associated S. aureus bacterial infections. This approach is focused on effective prevention of serious S. aureus infections.
Nabi’s previous investigational polysaccharide conjugate vaccine, StaphVAX, was based on patented technology that Nabi had licensed from the Public Health Service/National Institute of Health (NIH). It contained the two main capsular types, 5 and 8 found in the outer coating of more than 80% of S. aureus bacteria. The capsular polysaccharide molecules are linked, or conjugated, to a non-toxic, carrier protein derived from the bacteria Pseudomonas aeruginosa (Pseudomonas exoprotein A). To enhance the efficacy of this vaccine, Nabi has developed and plans to add a new and patented surface polysaccharide component, 336. S. aureus Type 336, accounts for the approximately 20% of S. aureus infections that do not form a polysaccharide capsule in the human bloodstream. The 336 conjugate was evaluated in a phase I/II human trial and shown to be safe and generates antibodies in humans that are specific and mediate protection against 336 positive strains of S. aureus. Together, these three polysaccharide conjugates cover all clinically significant serological types of S. aureus.
Toxins are major contributors to the virulence of S. aureus causing infections in the hospital as well as the community. Nabi had identified two vaccine candidates that cover at least three highly virulent toxins. One of the toxins in animal models is produced by almost all clinical isolates and the other is toxin associated with severe skin and soft tissue infections caused by the newly emerging multi-drug resistant community acquired MRSA strains. Nabi has used genetic engineering technology to render the toxins non-toxic so they can be used safely. Adding these two components to Tristaph will produce the multi-targeted S. aureus vaccine, PentaStaph.
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