For his work in developing a vaccine against Clostridium difficile, James Galen, PhD, was awarded a $50,000 prize for the best technology from the Baltimore campus of the University of Maryland, at the annual joint meeting of the University of Maryland and Johns Hopkins Commercial Advisory Board.
Inventors from both universities presented a total of nearly 30 technologies to a group of investors and advisors from the pharmaceutical and biotech industries at the meeting on the Hopkins Baltimore campus in early November.
Galen said, "Now that we are demonstrating immunogenicity in mice, I want to quickly advance this vaccine through partnering with industry." He is an associate professor at the University of Maryland School of Medicine's Center for Vaccine Development, which is recognized worldwide for its research and clinical development of vaccines to counter deadly diseases such as cholera and typhoid fever.
Transmission within hospitals is a major setting for C. difficile infections. Galen said that in the last several years, the reported incidence and severity of C. difficile-associated disease (CDAD) have increased dramatically, according to several medical sources. C. difficile is a spore-forming bacteria that is the most commonly identified cause of antibiotic-associated diarrhea. The disease was linked to 5.7 U.S. deaths per million persons in 1999, a rate that quadrupled in five years to 23.7 deaths per million in 2004.
People most at risk for infection are the elderly, patients with compromised immune systems, patients recovering from surgery, or patients who require a prolonged stay in a health care facility. CDAD typically affects patients who have been on antibiotics for a considerable time and whose normal intestinal bacteria have been compromised by those antimicrobial agents, allowing C. difficile a chance to multiply. Disease-causing spores from C. difficile can be found on many common surfaces, are long-lived, and cannot be eliminated by antimicrobial soaps, Galen said. "These spores can develop into a case of mild diarrhea, but can also rapidly progress into severe intestinal disease and death."
Estimates of the cost for treatment in the U.S. have soared from $1 billion in 2002 to $3.2 billion in 2007, due to a dramatic increase in the number of cases and increasing severity of the disease. An emerging more virulent strain has been associated with recent epidemics of CDAD in North America and Europe, with increased morbidity and mortality.
There is no current vaccine for CDAD. Recommended treatments include halting administration of antibiotics, then treating with metronidazole or oral vancomycin. A 2008 article in The New England Journal of Medicine states that recurrent infections can occur within one of three weeks following cessation of antibiotic treatment. The risk of recurrent infection rises from about 20 percent after the primary infection to approximately 40 percent after the first recurrence, further increasing to more 60 percent after two or more recurrences. This pattern presents major challenges for control and management of this disease.
Research by Galen's group has so far demonstrated an immune response to the vaccine in mice. It's anticipated that the vaccine will be very useful to prevent recurrent disease, that is, a post-infection treatment rather than a preventive vaccine, said Galen. This could be a strategy for vaccinating against a variety of other diseases, including against biodefense threats, such as anthrax, another area in which the Center for Vaccine Development has made important advances.
The C. difficile vaccine is genetically engineered from a Salmonella bacteria that has been rendered harmless by the researchers. Nancy Cowger, PhD, licensing officer with the University of Maryland's Office of Technology Transfer, explains that Galen and his colleagues "have achieved significant clinical success with live vector vaccines based on attenuated salmonella bacteria." Adapting these same strains to deliver foreign antigens, such as C. difficile proteins, offers exceptional flexibility for new vaccine development.
The prize to Galen was awarded by a joint commercial advisory board. He said "I am delighted to receive this award, which will allow us to proceed directly into further animal experiments to refine our immunization strategy. I am extremely optimistic that we can succeed with our novel live vector approach to vaccinate against such a difficult disease."
The advisory board, also awarded a $50,000 prize for the best technology from the Johns Hopkins University group to Cynthia Salorio, PhD, assistant professor, for "Armware: a programmable vibrating wristband to treat motor disorders."
The award was funded in part and devised by the Maryland Biotechnology Center, as part of its goals to stimulate the transformation of scientific discovery into new business development.