Lyme disease vaccine trial needs participants

Sep. 21—Researchers developing a Lyme disease vaccine are seeking local residents to participate in a clinical trial.

"There's so much more to be discovered," Dr. Jackson Booth said of how science is always changing.

Booth is a principal investigator for a study being led by Care Access, which she described as a dedicated research company with access to clinical trials.

The company is decentralized, meaning that it can send a team of experts to set up temporary sites anywhere and anytime, while most clinical research is done at a hospital or university.

Care Access has a half-dozen sites in Pennsylvania, and Sharon and Grove City are joining the list.

The Sharon site is at Sharon Medical Group Family Medicine at the Primary Health Network building, 63 Pitt St.

Details about the Grove City site are still in the works.

Those who are interested can learn more by calling 877-565-5112 or visiting fightlyme.careaccess.com

Booth and her team are looking for individuals ages 5 and up with healthy immune systems to be part of the study, which involves four injections, seven in-person visits, one phone call and blood work — checking in and providing feedback for a total of about 2 1/2 years.

They aim to collect more information to help with the progress of the Lyme disease vaccine being made by Pfizer and Valneva, its European partner.

"This disease can have long-term debilitating effects," she said.

Those effects can include arthritis, cardiac issues or neurological complications. For some, the disease never clears up completely.

Pennsylvania reports roughly 100,000 cases of Lyme disease a year with many of those individuals being about 50 and under.

"I am looking at the safety and well-being," Booth said of wanting to prevent the disease.

Lyme disease is transmitted to humans through infected ticks, and Pennsylvania's state parks and recreational opportunities mean people spend a lot of time outdoors.

"People come into contact with wildlife fairly frequently," Booth said.

She is eager to get more participants engaged in the clinical trial, which she said is similar to other vaccine trials she's worked on: HIV, COVID-19, Zika and Ebola.

Those who have already had Lyme disease are eligible to register unless the individual is experiencing long-term effects from the previous infection.

Once a participant signs up, they are screened over the phone to see if they are a good candidate for the trial, Booth said.

If they're good to go, then more information about their medical history is collected and their first injection appointment is scheduled.

Injections are administered in the upper arm. Participants will receive the second dose two months later, the third dose in the spring, and a booster 12 months later.

Some people will receive the active study drug while others will get the placebo. Care Access also provides resources about Lyme disease and how to protect against ticks.

Clinical trial team members will be looking for side effects immediately after each injection and the immune response will be monitored with blood work.

Participants will also track their part of the trial with an electronic diary that can be accessed through a smartphone app.

There is a stipend, though Booth is hopeful that folks are interested in being part of scientific research.

The COVID-19 pandemic has helped more people understand the importance of clinical trials, helping to gather solid data that could prevent death and disease, she said.

She understands that some may be skeptical of clinical trials but says that the process is heavily regulated and monitored by the Food and Drug Administration.

The Lyme disease vaccine study is already being tested on people, and there are two other similar studies being conducted.

Care Access is not tied to the FDA or the pharmaceutical companies reviewing the research, Booth said.

Local healthcare leaders are excited about Mercer County's role in helping to further the Lyme disease vaccine study.

Pennsylvania is among the states with the most cases of Lyme disease according to the Centers for Disease Control and Prevention; the eventual vaccine will improve the community's overall health, said Jennifer Barborak, executive director of the Buhl Regional Health Foundation.

The foundation held a "Lyme Disease Lunch" program earlier this year to learn more about Lyme disease.

The "Ticks and Tickborne Diseases" YouTube video can be found by visiting buhlregionalhealthfoundation.org/education and clicking "View Previous Health Chats and Lunch and Learns.