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2nd vaccine candidate identified

By Mike Stepanovich

Scientists with the Valley Fever Vaccine Project, administered by the CSUB Foundation, have identified a second vaccine candidate that looks very promising as they transition from the research phase to the development stage of a valley fever vaccine.

Development is the next stage as the project moves forward from the Feb. 18, 2004, announcement that the project had identified a vaccine candidate, said Dr. Richard Hector, director of the Valley Fever Vaccine Project. As a first step in this transition, he said, the project has contracted with the University of Nebraska to develop the methods to produce the vaccine candidate in sufficient quantities to conduct further testing and demonstrate that the vaccine was viable.

"The first stage in the manufacturing efforts has been successful," Hector said. "We have a fermentation method that works at a 15 liter scale. The University of Nebraska will now use the raw material to start the purification efforts. Now we need to produce enough material so that we can start the remaining phases of the project leading up to the filing of the IND application with the FDA. There's a long list of things that needs to be done before we get to human testing."

The scientists who have been working on the Valley Fever Vaccine Project since its inception in 1997, met recently in Bakersfield to report on their progress to the CSUB Foundation board, and outline their plans for the development of the vaccine.

The two vaccine candidates both showed 100 percent protection against Valley Fever in laboratory mice.

The first vaccine candidate, developed by Dr. John Galgiani at the University of Arizona, is a recombinant protein that was cloned from the fungus that causes valley fever. The second candidate, developed by Dr. Garry Cole at the Medical College of Ohio in Toledo, is the valley fever fungus that has been genetically modified so that it cannot reproduce when introduced into a mammal. Thus, it is an attenuated mutant vaccine; an approach somewhat similar to that used for live polio and smallpox vaccines, but using more modern methods.

That led to one question about the prospects for a vaccine anytime soon. Lead investigator Dr. George Rutherford of the University California, San Francisco said that while much has been accomplished there is still much to be done. He said he hoped human trials would be able to begin within five years.

The principal scientists on the project are:

• Galgiani, professor of medicine at the University of Arizona and founder and director of the Valley Fever Center for Excellence at the University of Arizona.

• Cole, professor and chairman of the Department of Microbiology at the Medical College of Ohio in Toledo.

• Dr. Theo Kirkland III, assistant director of the microbiology laboratory and a staff physician at the Veterans Administration Medical Center in San Diego, a member of the Center of Molecular Genetics at the University of California, San Diego, and associate professor of pathology and medicine in residence, Division of Infectious Diseases at UCSD.

• Dr. Demosthenes Pappagianis, professor in the Department of Medical Microbiology and Immunology at the University of California, Davis School of Medicine.

“We are most grateful for the work these scientists have done,” said CSUB President Horace Mitchell. “This is an enormous body of work that these scientists have accomplished, When we began this project back in 1996 and ’97, we hoped that we would be successful and dreamed that this moment would come. Our hopes have been realized, and our dreams have come true.”

Since the beginning of the research project under the auspices of the CSUB Foundation, with its initial grant from the California HealthCare Foundation and an appropriation from the California Legislature, the researchers have been working towards the goal of moving potential vaccine candidates from the research phase to clinical trials.

Valley Fever is caused by a fungus, coccidioides immitis, which exists in the soil in various 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.

The disease has been recognized as a significant medical entity since the 1890s, and its association with the San Joaquin Valley, particularly Kern County, was realized during the first three decades of the 20th century.