A Virginia Commonwealth University researcher has developed a test to more effectively detect Lyme disease in humans. And after successfully developing a Lyme disease vaccine for canines last year, VCU researchers are now closing in on a human vaccine for the disease.
Next week, Richard T. Marconi, Ph.D., professor in the School of Medicine’s Department of Microbiology and Immunology, will be awarded a $510,000 one-year grant from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to advance the development of a human Lyme disease vaccine. In addition to NIH support, this effort is supported by the Stephen & Alexandra Cohen Foundation.
Marconi said public demand for improved Lyme disease diagnostic and preventive strategies, and his sympathy for sufferers of the disease, drove his efforts.
“Lyme disease can be a devastating illness and its incidence has increased dramatically over the past decade. I routinely receive phone calls and emails from people across the country who are dealing with Lyme disease. It is heartbreaking to hear their personal stories,” Marconi said. “We are excited that after many years of research, we are now in a position to offer more effective alternatives for both prevention and diagnostics.”
Lyme disease is the most common vector-borne illness in the United States, according to the Centers for Disease Control and Prevention, with the vast majority of cases occurring in the Northeast and upper Midwest. Fourteen states, including Virginia, account for more than 96 percent of reported cases. Lyme disease has spread throughout much of the entire eastern half of the U.S. and many cases have been reported on the West Coast. The spread of the disease is attributed to a rapid expansion of the tick population throughout North America.
VCU’s Innovation Gateway led the commercialization efforts for Marconi’s diagnostic test. The Innovation Gateway’s mission is to facilitate the commercialization of university inventions for the benefit of the public, which includes both licensing to existing companies and new venture formation. The Innovation Gateway brought Marconi’s test to the attention of Mickey Ramchandani, founder and CEO of Global Lyme Diagnostics. He created the company to market and distribute the test. Commercialization of the test began in June.
“Identifying and attracting an experienced entrepreneur is critical for creating successful startup companies,” said Ivelina Metcheva, senior executive director of the Innovation Gateway.
A precise test
The diagnostic test developed by the Marconi lab uses a new approach called Chimeritope Technology. Defined segments of several different Lyme disease protein variants are joined together to develop new proteins called chimeritopes. These proteins are able to detect the diverse antibody responses that develop in mammals infected with Lyme disease. The diagnostic test detects the disease during its earliest stage, which allows for better treatment options.
Marconi said other tests are not regarded as highly accurate and most Lyme disease diagnoses are based on symptoms.
“That has potential problems because Lyme doesn’t always present the same way in all individuals,” he said. “Making a diagnosis based on clinical presentation sometimes is an obvious call but very often it may not be. Without an accurate confirmatory test an individual might progress to a more late stage when they could have in fact been treated very early on.”
Building a vaccine
The human vaccine currently in development is designed to prevent Lyme disease by stimulating immune responses that can inhibit transmission of the bacteria from ticks to mammals and kill bacteria that enter the body. Chimeritopes are key to the vaccine’s function because they can prevent infection with diverse strains of Lyme disease bacteria.
Marconi said the success of VANGUARD® crLyme (Zoetis), a canine Lyme disease vaccine that entered the market in 2016, has significantly advanced efforts to develop a human vaccine.
“In terms of moving forward with a human vaccine, we have learned an incredible amount from our experience with the canine vaccine. Several million doses of the vaccine have been administered to canines over the past year and a half,” Marconi said.
Marconi said his lab is “close to finalizing the science of the human vaccine” but there are many regulatory requirements that must be addressed before a final product can be produced.
“We expect that redesigning the current vaccine for use in humans will be a relatively simple process based on the information that we acquired over the past few years,” Marconi said.