Univax Biologics Inc. announced Wednesday that clinical trialsare under way on its vaccine for fighting Staph infections inkidney failure patients.
HyperVax+Staph A vaccine is made from two strains ofStaphylococcus aureus, the most common infection of end-stagerenal disease (ESRD) patients undergoing peritoneal dialysis.The Phase I trials will be conducted in both ESRD patients andhealthy volunteers.
The trials, which began Feb. 26, are the latest in a series ofNational Institutes of Health-sponsored human trials on S.aureus vaccines that Univax and NIH have been developingunder a Cooperative Research and Development Agreement(CRADA).
HyperVax+Staph A is a bivalent polysaccharide-proteinconjugate vaccine, consisting of capsule polysaccharides fromboth Type 5 and Type 8 S. aureus strains, which taken togetheraccount for more than 90 percent of all S. aureus infections.The capsular antigens are conjugated to a geneticallyengineered detoxified Pseudomonas toxin (exotoxin A) that hasan adjuvant-like effect, to enhance the immune response.
The earlier clinical trials tested monovalent forms of thevaccine. In 150 patients, both of the monovalent componentswere well-tolerated and elicited the desired antibody levelsagainst the target strains.
Univax (NASDAQ:UNVX) of Rockville, Md., is "developingHyperVax+Staph A as a vaccine and also as a tool for allowingus to generate specific polyclonal antibody products fromdonors," said Thomas Stagnaro, the company's president andchief executive officer.
"The vaccine is being developed to provide protectiveimmunity for those chronically at risk of infection," he said,"while the polyclonal antibody is intended for use inpreventing Staph infections in patients at acute risk such as intrauma or surgical patients."
The company's stock was off 75 cents a share on Thursday,closing at $6.75.
-- Jennifer Van Brunt Senior Editor
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