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   from the issue of March 11, 2004

Facility to work on Valley Fever vaccine

The UNL Biological Process Development Facility, directed by Professor of Chemical Engineering Michael Meagher, will begin process research and development to produce a vaccine for human clinical trials against coccidioidomycosis, or Valley Fever.

After four years of research at five other research centers, scientists with the Valley Fever Vaccine Project, administered by California State University, Bakersfield Foundation, announced in February that animal studies had identified a vaccine, and pharmaceutical development would begin.

As a first step, the California State University, Bakersfield Foundation recently contracted with UNL to develop a fermentation and purification process for the vaccine suitable for clinical trials. The UNL Biological Process Development Facility, in the Department of Chemical Engineering in Othmer Hall, is one of the few university facilities in the United States that can take vaccines and therapeutics from the recombinant gene stage to a product suitable for human clinical trials as mandated by the Food and Drug Administration.

“The first step is to evaluate the recombinant yeast expression system producing the recombinant vaccine candidate using 5 L bench-scale fermentors,” Meagher said. “Studies at UNL will determine the ability of this particular yeast strain to produce a vaccine at levels suitable for manufacturing. If the yeast expression system meets expectations,” he said, “then we can proceed to full product development.”

Meagher said the Valley Fever Vaccine Project is one of several in the Biological Process Development Facility. Just last year, UNL received $6.5 million from the National Institutes of Health/National Institute of Allergy and Infectious Diseases with Dynport Vaccine Co. to develop fermentation and purification processes for a recombinant heptavalent botulinum vaccine.

Primary funding for the Valley Fever project comes through a number of sources, including the California HealthCare Foundation, the State of California Department of Health Services, the Centers for Disease Control, and local Bakersfield organizations. UNL will receive about $102,000 to evaluate the suitability of the recombinant yeast strain for manufacturing as the first step in the pharmaceutical development phase of the project. Meagher said this stage of the project should be completed in the next three to five months so that full process development can get started.

Valley Fever is caused by a fungus, Coccidioides immitis, which exists in the soil in areas of the American Southwest, northern Mexico and Central and South America that have arid or semiarid conditions and hot summers with mild, non-freezing winters. These fungal spores become airborne when the soil is disturbed by winds, construction, farming and other activities. In susceptible people and animals, infection occurs when spores are inhaled, initiating pulmonary infection. Valley Fever is not a “contagious” disease; it is not passed from person to person. But it can progress to chronic and disseminated disease and can be fatal. Antibiotics are available to treat the disease, but they are only partially effective and often require months or years of treatment.

The disease has been recognized as a significant medical entity since the 1890s, and its association with the San Joaquin Valley in California was realized during the first three decades of the 20th century. The Valley Fever Vaccine Project began in 1997 after a major Valley Fever outbreak from 1991 through 1994 renewed interest in vaccine development. An estimated 100,000 to 150,000 people are exposed to Valley Fever each year in the United States, with approximately one-third of the new infections occurring in California.



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