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A Vaccine Against Valley Fever Finally Works—for Dogs
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Maryn McKenna

Science
11.11.2021 07:00 AM


A VACCINE AGAINST VALLEY FEVER FINALLY WORKS—FOR DOGS

People and canines suffer horribly from the disease, caused by a fungus
spreading through the increasingly dry US Southwest.
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Photograph: CDC/SCIENCE SOURCE

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An experimental vaccine that could protect millions of people living in the
American Southwest from valley fever—an infection caused by a soil-dwelling
fungus that is difficult to treat and can cause disability and death—has passed
its first test of efficacy and is moving toward federal approval, possibly
within two years.

The catch: The vaccine was tested in, and will be developed for, dogs. A formula
that could be given to humans, if it can be achieved, lies many years and
millions of dollars down the road. But researchers say even this first step is
notable, a significant milestone on the way to preventing potentially hundreds
of thousands of human cases a year.

To be clear, this vaccine is needed for dogs, too. They aren’t just a model
system for lab work; for reasons that are not well understood, they develop the
disease and its most severe manifestations at higher rates than humans do.
Possibly 30 million dogs live in the area endemic for valley fever, which
centers on Arizona, stretches from California to West Texas, and reaches into
Nevada and Utah. In some Arizona counties, 1 in 10 dogs develops the disease
each year, and it is the No. 1 cause of dogs being surrendered to animal
control. A vaccine that could protect them would save loved pets from suffering
and reduce the costs borne by owners and shelters.



The vaccine candidate, which was developed by the Valley Fever Center for
Excellence at the University of Arizona College of Medicine, uses a version of
one of the fungi responsible for the infection, from which a gene that controls
virulence has been deleted. Working with researchers at other universities and
biotech startup Anivive Lifesciences of Long Beach, California, the team
inoculated dogs with a solution containing live spores from the altered fungus.
They found a two-dose regimen of an initial shot and a booster was safe and
protected dogs against developing disease when they were exposed to wild fungus
in the lab. The results were published ahead of October inclusion in the journal
Vaccine.

“We think the results are very convincing that the vaccine shows robust
protection in this model—and it’s an aggressive model, compared to wild-type
infection,” says John Galgiani, senior author on the paper and director of the
University of Arizona center. The group is working now on scaling up the
small-batch prototype developed in his lab to produce a shelf-stable formula
that could be commercialized for use in dogs. The team will then submit it to
the US Department of Agriculture, which regulates animal vaccines, for
conditional approval. They hope to see it distributed by 2023.



It’s the first good news in a long trail of disappointments that stretches back
to the 1980s, when Galgiani was part of a thinly funded research group
investigating a human vaccine candidate based on inactivated fungus. The trial
was unsuccessful—the injection-site reactions were too painful—and from then on,
there has been no vaccine for valley fever, nor for any fungal disease.

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In addition to submitting the formula’s portfolio to the USDA, the next step is
to run a safety trial with about 600 dogs in the real world. Owners would
volunteer their pets to receive the vaccine for free in exchange for having
their dogs examined a month later, says Dylan Balsz, Aninive’s founder and CEO.
Once the vaccine is licensed, the goal would be to sell it to veterinarians,
providing a preventive alternative to the year-long, and sometimes lifelong,
courses of drugs that dogs must be given once they are infected.



With luck, the income from those sales—Balsz estimates the price might range
from $30 to $60 per dose—could bootstrap the rest of the company’s portfolio,
which includes rights to develop the candidate as a human vaccine. For that
effort, they would seek additional partners. Anivive’s core business is mining
the research literature for abandoned compounds that can be repurposed as
veterinary medications. “But this has been our obsession,” Balsz says. “I didn’t
appreciate that there has never been a fungal vaccine.”



A human formula is what fungal-infection experts most hope to see. “We
definitely need a vaccine,” says George Thompson, an associate professor of
medicine and codirector of the Center for Valley Fever at the University of
California, Davis, which is both a major treatment center for human patients and
the institution where that first unsuccessful vaccine was tested. “This is a
disease that continues to increase yearly, and it affects our most vulnerable
populations: farm workers, solar-field construction workers in the Central
Valley. Those are groups that don't have resources for health care if they
experience the complications of valley fever. So preventing it through a vaccine
would really be a huge leap forward.”

Several things have made it difficult to counter the threat of valley
fever—technically coccidioidomycosis, caused by the organisms Coccidioides
immitis and Coccidioides posadasii. First, it is caused by a fungus. That means
it is more like us, on a cellular level, than bacteria or viruses are. Drugs
that can kill fungi may also damage our cells.

But also, while fungal infections are a massive problem worldwide—one
organization estimates there may be 300 million people infected and 1.6 million
deaths every year—valley fever is a niche disease within that group. Its range
seems to be confined to the western US, Mexico, Central America, eastern Brazil,
and northern Argentina. The latest count of US confirmed cases was 18,407 in
2019, though researchers estimate the true count could be 150,000 cases or
higher.

The delta between known and suspected cases is due to a complex set of factors.
Not everyone who breathes in the spores, which break free from the fungus in the
soil in dry times and can travel hundreds of miles, develops illness. Those who
do may mistake its symptoms of fever, cough, and fatigue for the flu. Only about
10 percent of infected people develop serious manifestations, such as fungal
growths that occlude their lungs, and only about 1 percent develop the most dire
complications: fungal invasion of their bones, joints, spine, and brain.

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Plus, because valley fever is a regional disease, a physician needs regional
knowledge to recognize its existence. Someone working in New York City might not
consider it the way a physician in Las Vegas would. Compounding that lack of
recognition, only 26 states (plus Washington, DC) rank it as something public
health authorities have to be notified about. And although California is one of
the most-affected states, second only to Arizona, California’s affluent tech
workers rarely develop the disease. Its chief victims are people who are already
immunocompromised or who work outside or are exposed to warm, windy, dusty
conditions: not only farmworkers, but contractors, road crews, and excavators
and homebuilders laying out subdivisions.

Others at risk: military personnel assigned to southwestern bases and winter
vacationers from cold northern states, all of whom return home to places where
doctors are unlikely to recognize the illness. As I wrote for Scientific
American this summer, in 2018, CDC epidemiologists doing a nationwide sweep for
the disease found cases in 14 states that mostly lie along the Canadian
border—places so cold that the infections could not have occurred there. After
unravelling the patients’ past travel, investigators recognized the individuals
had been infected somewhere to the south and brought the fungus home.

“If we achieved a vaccine, definitely people who lived in the endemic area would
be where to start, people who are immunocompromised,” Thompson says. “But it
also might become a mainstay of travel medicine. A travel advisory before
visiting certain locations would be interesting to contemplate—though I don’t
envision states wanting to caution people to get vaccinations before visiting.”


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Valley fever is estimated to cost the US $3.9 billion per year, and by one
estimate, a vaccine could save potentially $1.5 billion in health care costs
every year. But that cost, and thus the urgency to achieve a vaccine, is almost
certain to increase because climate change is expanding the locations where
valley fever is an infection risk. The fungus responds to temperature and
humidity: It needs a warm environment to thrive, and in damp conditions it
remains quiescently in the soil. But as climate warming increases, new territory
will open up for Coccidioides, and shifting rainfall patterns mean areas where
it has begun to grow will dry out enough for it to break apart and drift. There
is already a known area of vulnerability in the center of Washington State, a
place that was previously thought to be too cold for the fungus. In 2010, three
people contracted valley fever there, including a construction worker and a teen
who had been roaring around on an ATV.



In 2019, Morgan Gorris, an Earth system scientist at Los Alamos National
Laboratory, used temperature and rainfall data to estimate more precisely where
valley fever is endemic, based on the fungus’s known behavior in ranges of
humidity and warmth. Using those findings, and combining them with different
climate-warming forecasts, she modeled how valley fever’s range might expand
under different scenarios of greenhouse gas emissions. Under the highest-warming
scenario (a global rise of almost 9 degrees Fahrenheit), the area where the
disease could become endemic would double in size by the year 2100, covering 17
states, including Idaho, Wyoming, Montana, Nebraska, and the Dakotas. The number
of cases, the model predicted, would rise by half. In another analysis based on
that work, she estimated that by the year 2100, the cost of valley fever to the
US would reach $18.5 billion per year.

That looming bill, along with the illness and death underlying it, may be the
best rationale for reaching to develop a vaccine. “Climate change is going to
exacerbate ongoing threats and cause new threats,” Gorris says. “We’ll need
resources in the future to adequately combat emerging diseases. Having a vaccine
to address the risk of valley fever will allow us to free up resources to tackle
other climate change issues, especially those related to human health.”

--------------------------------------------------------------------------------

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Maryn McKenna is a senior writer at WIRED covering health, public health and
medicine, including the Covid pandemic, and a faculty member at Emory
University’s Center for the Study of Human Health. Before coming to WIRED she
freelanced for magazines in the US and Europe including Scientific American,
Smithsonian, The... Read more
Senior Writer
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Topicsvaccinesinfectious diseasedogsclimate changepublic
healthhealthpharmaceutical industry



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