Three faculty members from the Division of Infectious Diseases, also affiliated with the Valley Fever Center for Excellence at the University of Arizona College of Medicine – Tucson, participated this month in a workshop in Rockville, Maryland, on developing vaccines for fungal diseases, in particular Valley fever, formally known as coccidioidomycosis or cocci.
The fungal diseases vaccine workshop, Aug. 13-14, was sponsored by the U.S. Food & Drug Administration, National Institutes of Health and Centers for Disease Control and Prevention and focused specifically on vaccines to prevent Valley fever.
The event offered an opportunity for Valley Fever Center founding director John N. Galgiani, MD, Fariba Donovan, MD, PhD, a center researcher, and Neil Ampel, MD, a professor emeritus, to update experts on the spread of incidence of the respiratory infection, expansion of rapid detection methods and pursuit of a vaccine.
“This is a particularly good time to focus on vaccines for Valley fever because it’s a growing problem across the Western U.S. with the spread of it more recently due to changing climates to areas where it hasn’t been before,” Dr. Galgiani said. “And with the breakthroughs that we’ve been experiencing for a vaccine for dogs, the time is right to begin work on a human vaccine.”
The Valley Fever Center’s partner on that since 2017 has been Anivive Lifesciences Inc. That’s when Anivive licensed the work of center investigators, Marc Orbach, PhD, and Lisa Shubitz, DVM, and their research team to produce such a vaccine. With success in the offing for the dog vaccine near, Anivive broadened its support team for a human vaccine and was awarded up to $33 million in contracts this summer by the National Institute of Allergy and Infectious Diseases, which is part of the NIH, toward that end.
At the FDA/NIH/CDC workshop in Maryland, Dr. Donovan presented on “A clinical overview of Valley fever,” Dr. Ampel (a former infectious diseases specialist with the Southern Arizona VA Health Care System) on “Valley fever diagnostics: Cell-mediated immune assays,” and Dr. Galgiani on “Current Valley fever vaccine candidates: Live attenuated vaccines from the dog model to a human vaccine.”
“Based on the science there’s no reason this vaccine we currently have couldn’t also protect humans,” Dr. Galgiani stipulated. “However, getting a vaccine licensed for humans entails a lot more understanding about safety and how well it protects. That’s a more ambitious effort because it costs a lot more money to ensure.”
The NIAID contract to develop the U of A vaccine through a first-in-human Phase I clinical trial underscores passage of a significant milestone in the center’s goals, according to Dr. Galgiani. It was launched in 1996 with the aim of broadening awareness of the disease, improving detection and developing ways to treat and prevent infections and the impact they may have on people with other medical conditions.
Valley fever is caused by fungal spores of Coccidioides immitis or Coccidioides posadasii found in arid desert soils of the U.S. Southwest that when inhaled can cause a mild or severe respiratory infection that resembles the flu or pneumonia. At its worst, it can disseminate through the blood, moving to skin, bones and joints, and/or the spinal cord and brain in what’s known as disseminated cocci. Between 10,000 and 20,000 cases of Valley fever are reported each year, with the vast majority in Arizona and California. The CDC reports that about 200 people die each year from cocci-related illnesses.
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