The overall goal of the cooperative R&D agreement (CRADA), which will involve researchers from Uniformed Services University of the Health Sciences’s (USU) infectious disease clinical research program (IDCRP) and Nabi, is to develop a licensed pentavalent S aureus vaccine to prevent skin and soft tissue infection.
The CRADA proposes a series of collaborative clinical trials. These include Phase I evaluation of the safety and immunogenicity of the two toxoid compounds, Panton-Valentine Leukocidin and alpha toxin; Phase II evaluation of the safety and immunogenicity of a trivalent vaccine containing the capsular polysaccharide types 5 and 8 and cell wall polysaccharide type 336; and Phase II evaluation of the safety and immunogenicity of the pentavalent vaccine containing all five components given in two separate, simultaneous doses.
Raafat Fahim, president and CEO of Nabi Biopharmaceuticals, said: We are proud to collaborate with the USU and its IDCRP and The Henry M Jackson Foundation for the Advancement of Military Medicine (HJF) to further advance the development of Nabi’s vaccine against S aureus infection.
With the additional resources this agreement brings to bear, Nabi is able to continue to advance the development of PentaStaph much further and much faster than we could have on our own.