A vaccine created by researchers at the University of Georgia effectively guards against and treats vaginal yeast infections in mice, as detailed in a recently published research.
This represents the latest use of the vaccine, which has previously been proven to protect against the three predominant fungal pathogens in four preclinical animal studies, including nonhuman primates. These three fungal species account for over 80% of deadly fungal infections.
The new discovery paves the way for the vaccine to progress into clinical trials. If it proves effective, this vaccine will be the first to avert pathogenic fungal infections, which the World Health Organization recognizes as a significant threat to public health.
We cannot simply continue… attempting to produce new medications to combat fungal infections because we are bound to fail.” —Karen Norris, College of Veterinary Medicine
“What keeps researchers like myself awake at night is the rising resistance to antifungal medications,” noted Karen Norris, the principal author of the study and a professor of immunology and translational biomedicine in the UGA College of Veterinary Medicine. Norris is also the CEO and founder of NXT Biologics, the entity behind the vaccine. “This is not mere speculation. We are currently experiencing it.
“And we cannot merely keep fighting to develop new medications to tackle fungal infections, or we will inevitably lose. These organisms are consistently evolving to resist new treatments.”
The vaccine, referred to as NXT-2, seeks to bridge that gap, preventing fungal infections proactively and diminishing the requirement for antifungal treatments.
Initial clinical trial to address yeast infections; subsequent trials will target severe infections
The vaccine will initially be examined in women experiencing recurrent yeast infections, also known as recurrent vulvovaginal candidiasis or RVVC.
Attributed to a form of candida fungus, the condition impacts hundreds of millions of women worldwide. It incurs billions of dollars in healthcare expenses, medications, and diminished productivity in the U.S. annually.
“RVVC may not be life-threatening, but it is incredibly distressing,” Norris remarked. As many as one in 10 women experience this condition in their lifetime, enduring three or more yeast infections annually. “There is a significant demand for a solution.”
The current treatment regimen relies on a single class of drugs, increasing the chance that the treatments will develop resistance and become more challenging to manage moving forward. These drugs are also unsuitable for use during pregnancy and do not avert subsequent infections.
I trust that this vaccine will be most beneficial for individuals at elevated risk for extremely dangerous, life-endangering infections.” —Karen Norris
The majority of women dealing with recurrent yeast infections are young and generally healthy, making them an ideal candidate group for a Phase 1 clinical trial.
The outcomes will steer future trials in more susceptible patient demographics, such as transplant recipients and cancer patients, who are particularly at risk for severe fungal infections also addressed by the vaccine.
“I once had a doctor tell me, ‘I have patients whom I manage through stem cell transplants for their cancer therapy, only for them to develop aspergillosis. Quite often, I lack sufficient treatment for that,’” Norris explained. Pulmonary aspergillosis is a severe complication arising from this treatment, with up to half of those patients succumbing to the infection.
“That’s the area where I think this vaccine will be most impactful: among those at high risk for extremely hazardous, life-threatening infections.”
Fungal infections: An escalating public health challenge
Fungal infections primarily occur in individuals with immune disorders, including those with uncontrolled HIV or compromised immunity due to treatments such as chemotherapy or anti-inflammatory medications.
However, earlier studies conducted by Norris, postdoctoral fellow Emily Rayens, and José Cordero from the College of Public Health revealed that the at-risk population has broadened in recent years.
This research indicated that individuals with diabetes; chronic obstructive pulmonary disease (or COPD); or co-infections like COVID-19, tuberculosis, or influenza face a higher risk of developing fungal infections.
As drug resistance escalates and infections become more challenging to manage, preventive measures become increasingly vital, Norris asserted.
This is the first fungal vaccine demonstrating extensive, cross-protective antifungal immunity across multiple animal models, which is promising for future clinical trials.
Published in Nature’s NPJ Vaccines, the research includes contributions from UGA Center for Vaccines and Immunology members Daniel Wychrij, Taylor Chapman, Whitney Rabacal, Hubertine Willems, and Kwadwo Oworae. Other co-authors comprise Emily Rayens, a doctoral graduate from UGA’s Department of Infectious Diseases, and Brian Peters from the University of Tennessee.
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