Trial for new vaccine underway locally; skeptics worry it's not enough
Over two and a half years participants in a new vaccine trial will receive four shots and check in with a doctor eight times.
By late 2024 advocates hope they will have a new weapon to battle Lyme Disease as cases rise across the country, especially in the Northeast.
“It’s really important to try to get ahead of this. Typically prevention like ... repellents, long-sleeve clothes and so forth just haven't proven to be effective over the years," said Dr. Peta-Gay Jackson Booth, an internal medicine physician and one of the lead principal investigators for the Lyme Disease vaccine trial.
Skeptics of the inoculations worry that the vaccine will stop people from practicing tick prevention. The bacteria that causes Lyme is not the only one carried by ticks that can cause health problems.
“Someone might have a false sense of security that if they get this vaccine they're just totally protected," said Michele Cassetori. She became an advocate with the Pennsylvania Lyme Resource Network after her family’s battle with tick-borne illnesses.
Biopharmaceutical company Pfizer partnered with French company, Valneva, to create the vaccine, named VLA15. It’s being studied in areas of the U.S. and Europe where Lyme Disease is highly endemic, according to Pfizer. The clinical trial aims to enroll 18,000 participants, according to clinicaltrials.gov.
The Centers for Disease Control and Prevention say Lyme Disease and associated tick-borne infections currently constitute a public health crisis. In North America alone, the number of people who are diagnosed with Lyme Disease annually is estimated to be near half a million.
Jackson-Booth works with Care Access, which was contracted by Pfizer to conduct the U.S. trials. Care Access is working with existing medical practices for the study. The vaccine is now in Phase 3, the last major trial in vaccine development before data is presented to the Federal Drug Administration for approval, said Jackson Booth.
Half of the participants are given saltwater placebo shots. After the first shot, a second inoculation comes 50 to 70 days after; the third shot is right before tick season; and a booster, the fourth and final shot, a year after, said Richard Blum, an internist based at Wilkes-Barre General Hospital who is participating in the vaccine trials.
Lyme Disease is caused by the bacterium Borrelia burgdorferi, most often carried by deer tick, a tiny black external parasite that lives on wildlife and in shady, moist areas usually at ground level.
Over the summer, Blum received a cooler for his office to store the vaccines.
“The vaccine works by causing the your body to produce antibodies, which are floating around in your bloodstream," he said. "So as the tick gets its blood meal, these antibodies enter that gut where the bacteria live and kill the bacteria in the tick.”
A bite doesn’t always cause Lyme or tick-borne disease. Symptoms of Lyme are typically flu-like but can be wide ranging depending on the person, from cardiac issues to facial paralysis.
Charlotte Moss has been a pharmacist for 26 years. After her husband’s Lyme diagnosis she got involved in the local Lyme Community.
He was suffering from heart and muscle issues, fatigue, joint stiffness and brain fog and went to five or six different specialists and had overnight stays at the hospital, Moss said, adding doctors told him he was fine.
“They never could find anything until we happened upon someone else who had Lyme Disease and said ‘Wow you sound like me, why don't you look into that’,” she said.
She owns Vine Pharmacy in Benton and specializes in Lyme treatments. Because of her pharmacy knowledge and knowing the minute details of Lyme, Moss is hesitant about the vaccine. She said the spiral-shaped bacteria mutates; it’s hard to treat.
"They still could get bit by a tick and get one of these other co-infections. So in reality, it might make it worse," she said.
Cassetori lives in Plains Twp. She was the director of education for the Pennsylvania Lyme Resource Network and also served on the organization’s board. She now offers free seminars spreading tick awareness across the state.
Her daughter, Camryn Cassetori, was diagnosed with late-stage — often called chronic Lyme Disease — when she was 13 years old.
“We had a very delayed treatment, because the diagnosis wasn't picked up early enough," she said. "It led to a lot of health complications for her.”
Camryn battled co-infections. She had a red mark that grew up her leg that doctors believed was cellulitis. She had joint pain and swelling. At one point the top of part of her leg atrophied, her mother said.
After receiving a positive Lyme diagnosis, she started with oral antibiotics — the typical treatment — and eventually moved to IV antibiotics. Camryn is now 20. After seven years of treatment, she is a healthy and happy college athlete, Cassetori said.
“That’s part of the problem for Lyme patients is that it goes undetected, undiagnosed, untreated for such a long time," she said. "If someone is vaccinated that may prompt them or their health care provider to just completely rule out Lyme disease, not even give it a consideration … So that will further delay, diagnosis, further delay treatment, and then definitely lead to many, many more long term health complications."
Her older daughter, Alyson Manley, also had a short battle with Lyme Disease.
"We caught that early enough because I had recognized the signs at that point," she said. "She was able to go through a round of treatment and did very well and never really progressed to anything else."
Cassetori believes that funding needs to be put towards developing good, accurate, early detection diagnostic tests.
“That is one area where I think ... we've kind of failed Lyme patients in the past," she said. "It was certainly my own personal experience within my family."
But regardless of her hesitancy about the vaccine, it is bringing awareness to Tick-borne diseases.
"Anything that brings that discussion back to the table, I think is a good thing," she said."
Jackson Booth said the other tick-borne illnesses "definitely are devastating as well and need to be addressed.”
But Lyme Disease is the most prevalent, she said.
The vaccine is also being tested in Connecticut – where the disease was first discovered in the 1970s – Maine, Maryland, Massacheusettes, New Jersey, New York, Rhode Island, Vermont and Wisconsin.
Pennsylvania has 16 study sites, the largest number of any of the locations. Locally, trial sites are in Scranton, Hazle Twp., Kingston, Pottsville, Sayre and Wilkes-Barre.
Jackson Booth said children ages 5 to 15 are the most susceptible to Lyme Disease and Care Access is hoping more families will sign up for the trials.
Additional medical care is available for those who enroll in the trial. Those who sign up also receive a small compensation.
Phase 3 began on Aug. 4 and is expected to be completed by Dec. 31, 2024, according to clinicaltrials.gov.
There are restrictions to participate in the vaccine study. For more details and to find out if you qualify, visit lymetrial.com.