Eight years after the market release of VANGUARD crLyme, a groundbreaking vaccine designed to prevent Lyme disease in dogs, the Marconi laboratory at Virginia Commonwealth University School of Medicine is on the verge of another medical milestone.

Under the leadership of Dr. Richard T. Marconi and Dr. Edward Schuler, researchers are in the final stages of developing advanced diagnostic tests and a novel vaccine for leptospirosis. Often referred to as "lepto," leptospirosis is a pervasive and potentially deadly zoonotic infection caused by the Leptospira bacteria.

Spread through contact with urine from infected animals, usually via contaminated water, soil, or food, leptospirosis poses significant risks to dogs, horses, cattle, pigs, and even humans. The CDC reports nearly one million human cases annually worldwide, resulting in approximately 60,000 deaths.

"Of all the zoonotic infections we hear about, lepto is by far the worst," remarked Dr. Marconi, the principal investigator of the project. "It can take a massive toll on both public health and the global health economy in terms of food production and pricing. To be able to diagnose it, treat it, and prevent it are all incredibly important."

The team is finalizing both a laboratory-based test and a point-of-care test for leptospirosis, similar to rapid COVID-19 or pregnancy tests. They are also developing a new vaccine to combat the disease.

'Lepto is Everywhere'

In October 2023, the American College of Veterinary Internal Medicine recommended that all dogs in the U.S. be vaccinated for leptospirosis. This recommendation has further fueled the Marconi lab's drive to bring their innovations to market, particularly for Dr. Schuler, who was inspired by his mother's work as a veterinary technician.

"Lepto is everywhere," Dr. Schuler emphasized. "You should be able to take your dog swimming or running in a field without worrying about them contracting lepto, potentially going into kidney failure, and possibly transmitting the infection to you."

Leptospirosis can manifest in two phases, starting with fever, chills, headache, muscle aches, vomiting, or diarrhea. Due to its symptoms' resemblance to other diseases, leptospirosis often goes undiagnosed, potentially leading to severe complications like kidney or liver failure or meningitis. While antibiotics can treat leptospirosis, delayed or inaccurate diagnoses can prove fatal.

A major hurdle in combating leptospirosis is the unreliability of current point-of-care diagnostic tests, which can yield false positives from antibodies generated by a previous vaccine, thereby discouraging their use and delaying treatment.

"If we can bring a better test to the market, it'll allow patients and animals to be diagnosed quicker and treated earlier for better outcomes," said Dr. Marconi.

Currently available alternatives to point-of-care tests are expensive laboratory tests that can take over a week to deliver results. The new tests developed by the Marconi lab aim to provide more accurate readings, unaffected by previous vaccinations or exposures, and are expected to revolutionize how leptospirosis is diagnosed and managed.

These new diagnostic tests and the vaccine have been in development for nearly five years. The objective now is to commercialize these technologies and make them available to clinicians and veterinarians.

"To know that one day veterinarians are going to potentially be purchasing our diagnostic tests to help provide a higher quality of care for pets and pet owners is sort of hard to wrap your head around," said Dr. Schuler. "But it's also very exciting."

The Marconi laboratory continues to push the boundaries of veterinary medicine, offering hope for better health outcomes for animals and humans alike.