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Lyme disease vaccine trials underway

By Kristin Emery, For The Greene County Messenger 5 min read
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Dr. Michelle Paulson

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Southwestern Pennsylvania has an abundance of ticks, which have the propensity to carry Lyme disease. (Courtesy of MetroCreative)

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Associated Press

This file photo shows a deer tick under a microscope in the entomology lab at the University of Rhode Island in South Kingstown, R.I.

news@greenecountymessenger.com

Researchers are once again trying to tackle a disease that sickens thousands of Pennsylvanians every year, and some volunteers in the Uniontown area are helping to test a new vaccine.

The state’s thickly forested landscape is ripe with ticks, which carry Lyme disease, and the number of cases continues to rise year after year.

“Lyme disease is a large problem in Southwestern Pennsylvania and in Pennsylvania as a whole,” explains Dr. Michelle Paulson, an infectious disease specialist with Allegheny Health Network (AHN). “It is likely underreported, so it is difficult to get an accurate count of the number of cases annually. In 2019, the CDC (Centers for Disease Control) reported 8,998 cases in Pennsylvania, but it is estimated the true number of cases may be 10 times that amount.”

While the true incidence of Lyme disease is unknown, estimates put the number of people affected annually to nearly 476,000 in the United States and 130,000 in Europe. Now, Pfizer and French biotech company Valneva are in the final phase of trials on a new vaccine to fight it.

What is Lyme disease?

Lyme disease is an infection caused by bacteria carried by black-legged (deer) ticks. Tick bites transmit the bacteria to humans, and the infection initially causes fever, joint pain, fatigue and very often a round bulls-eye rash. Lyme disease is the most common vector-borne disease in the United States. If left untreated, the infection can spread to other joints, the heart and even the nervous system.

Treatment usually involves antibiotics, but diagnosing Lyme disease is difficult and often hinges on whether a patient realized he or she received a tick bite.

Lyme disease cases continue to rise in the United States and Europe. While there already is a vaccine available for dogs, the only human version from GlaxoSmithKline was pulled off the U.S. market in 2002.

“There was a prior vaccine for Lyme disease that was available in 1998 to 2002; however, it was voluntarily removed from the market in 2002,” Paulson says. “It also targeted the outer surface protein A. It was removed due to lack of consumer demand, although the decision to discontinue the vaccine was likely multifactorial.” The previous vaccine wasn’t widely touted by doctors, was not tested in children, and was clouded in controversy due to unsubstantiated reports of related joint pain.

New clinical trial

Phase three trials started in August across the U.S. and Europe to test the first new Lyme disease vaccine in 20 years on as many as 6,000 volunteers. Pfizer’s phase two trials showed good response and no safety problems. Now, phase three will test whether the shot, called VLA15, is effective in blocking spread of the bacteria’s protein after a tick bite.

“VLA15 targets one of the outer surface proteins of the kind of bacteria that cause Lyme disease,” explains Paulson. “This specific vaccine targets outer surface protein A, or OspA. The trial is enrolling participants ages 5 and older from areas that have many cases of Lyme disease, such as Pennsylvania.”

Study participants are receiving two doses plus a booster of either placebo (saline) injections or the actual vaccine and will be monitored to compare whether the shot results in fewer cases of Lyme disease compared to the placebo group. Researchers will also watch for side effects and immune responses.

Some of those volunteers are in Southwestern Pennsylvania, thanks to doctors with Preferred Primary Care Physicians. Two of PPCP’s practices in Uniontown enrolled between 60 and 65 patients each into the trial.

“Lyme disease in the northeast is much more prevalent than in other parts of the country,” says Alan Abraham, PPCP’s Director of Clinical Research. “They wanted sites especially in Pennsylvania. It’s known for a high prevalence of Lyme disease.”

The volunteers already received two doses of the vaccine and will get a booster dose later this year. “Then we monitor the people very closely,” Abraham says. “It’s interesting because a lot of times people think, ‘Oh, I’m not going to be in a trial. I don’t want to be a guinea pig.’ Actually, when you’re in a trial, everything is so much more regulated and so many more times you’re in front of a health-are professional because you’re required to come in for certain visits, and we’re monitoring blood work and a lot of variables that normally most people would never get monitored.”

That monitoring will happen over the next two years to see if the vaccine affects the number of cases. “A year later in between they come back just for checkups, and we would draw blood to monitor things,” says Abraham. “They have to fill out diaries, so we’re in constant contact with these people.”

A third PPCP location in Pleasant Hills will be enrolling pediatric volunteers ages 5 to 17 for phase three trials of the vaccine starting soon. For information, call 412-650-6155 and press option 4 or send an email to lpellegrini@ppcp.org.

Pending the outcome of the phase three study, Pfizer could potentially ask for Food and Drug Administration approval of the vaccine in 2025.

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