UND researchers are closing in on a vaccine for in-hospital infections

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UND researchers are closing in on a vaccine for in-hospital infections

So you're in the hospital for minor surgery recommended by your family physician.

Your surgeon tells you it's a simple procedure.

You wake up with fever, chills and a nasty rash, unrelated to what you went into the hospital for.

"These types of in-hospital infections occur a lot more often than we'd like, especially in intensive care units," said Clint Schmidt, a cellular immunologist and director of research operations for NovaDigm Therapeutics. The U.S. Centers for Disease Control estimates that close to 2 million people annually contract in-hospital infections, and about 100,000 people per year die as a consequence.

These hospital-acquired, or nosocomial, infections, are largely produced by two families of nasty bugs: Staphylococcus (bacteria) and Candida (yeast/fungus). Schmidt, a former Minnesota Gophers center and West Fargo High School football player, says these two infectious agents can be virulent, deadly and tough to manage. There's a big problem: the resistance of these bugs to currently available drugs.

"That's why NovaDigm, a clinical stage vaccine development company, is researching a vaccine to prevent infections from methicillin-resistant Staphylococcus aureus, a bacterium, and Candida albicans, a yeast and a fungus," said Schmidt, who worked as a research postdoctoral scientist for Eli Lilly for several years.

Consulting with NovaDigm is David Bradley, an immunologist and executive director of the Center of Research Excellence for Avian Therapeutics for Infectious Diseases at the University of North Dakota School of Medicine & Health Sciences.

"We're very excited now because we completed two Phase I human clinical trials and we're currently enrolling volunteers for a Phase II proof-of-concept, or exploratory, trial for women suffering from recurrent, or chronic, vulvo-vaginal candidiasis, a recurrent yeast infection produced by Candida albicans," said Schmidt, whose experience also includes a stint at Dendreon, a company that developed the first — and now commonly used — cellular immunotherapeutic treatment for end-stage prostate cancer.

"We're going to do another trial of our vaccine in people who have this particular affliction three to four times per year," said Schmidt. "Besides the physical pain and discomfort it brings, it can also affect personal relationships; our vaccine aims to prevent recurrence."

Schmidt, who is the on-site research administrator for NovaDigm's facility in Grand Forks, says NovaDigm was founded by a group of physicians and scientists at the Harbor University of California-Los Angeles Medical Center.

"They found a virulence factor that allowed pathogenic Candida to stick to and invade human cells," Schmidt said.

Antigens, he explained, are mostly foreign proteins — say, bacteria surface structures — that trigger immune responses in the body. They do that by binding to specific antibodies produced by the body's white blood cells.

"Vaccines target the body's immune response by mimicking the foreign agent that can cause illness or disease," said Schmidt. Vaccines, including NovaDigm's preparation against recurring vulvo-vaginal candidiasis, are theoretically simple: they boost the body's power to fight or prevent a particular disease.

A vaccine resembles a disease-causing microorganism and is prepared from antigens or attenuated forms of the disease-causing agent. The vaccine thus triggers the body's immune response to the agent without suffering from a full-blown case of the disease.

"So, if you've been vaccinated, the next time the disease agent invades the body, the body's immune system recognizes it and attempts to destroy it," Schmidt said.

NovaDigm's vaccine is even more promising than originally targeted, Schmidt says.

"What's really compelling is that it potentially offers cross-kingdom protection, and that's never been done before," Schmidt said. Candida are yeasts or fungi; Staph are bacteria, representing two vastly different kingdoms, eukaryotes and prokaryotes.

"They're both pathogens, microorganisms that cause disease, but they're from two different kingdoms, as different from one another as people are from trees," Schmidt said.

"What we've done, and what we want to test more fully in the next phase of human trials, is to induce a very fast immune response," Schmidt said. "And that's the goal: to amp up the immune response as quickly as possible. The amazing thing for us is that we're getting 100 percent seroconversion by day 14 after vaccination."

In other words, they're getting quick results in fighting powerful infections that, if untreated, can kill close to half the infected patients.

"If we find this vaccine prevents progression of this disease, we'll also focus on totally preventing or slowing it down and reducing the severity," Schmidt said. "This is Phase IIA; we'll then move on to Phase IIB to test end-point efficacy of the vaccine."

"As this project moves forward, my lab will help to evaluate and test the candidate vaccine," said Bradley, whose specialty is immunology at the cellular level and who helped to recruit NovaDigm to North Dakota. "My team will be collaborating with NovaDigm in investigating the immune response to the vaccine. To get to the point where this is a proven vaccine, approved by the Food and Drug Administration, we still have to test to be sure that it actually works in people, not computer models."

With companies such as NovaDigm probing for solutions at the leading edge of this field, Bradley said signs are hopeful for new therapies against pathogens that resist the current pharmacological catalog.

"Immunology is so much a part of what and who we are," said Bradley, noting that this science is about how the body responds to prevent disease — and about digging into the reasons why it can fail.

Juan Miguel Pedraza University & Public Affairs writer

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