The deer tick nymph embedded in my daughter’s calf was hardly an invited guest on our summer vacation to Block Island, but there it was. The size of a poppy seed, it could’ve easily escaped attention, yet my 12-year-old has fighter-pilot radar for the potentially disease-toting little buggers. Upon learning that we hadn’t packed our tick tweezers, she dug her fingernails in with gusto, removing most of it. There’s a reason why no doctor recommends such a tactic, which often leaves bits of dismembered tick inside the skin. I doused the site with alcohol—but that night, a rash bloomed around the raised bump, prompting a panicked FaceTime with my father, an MD. With no pharmacy on the island, he ordered doxycycline in the morning from the mainland, delivered same-day via plane. As I pulled myself away from the beach to meet the Rx cargo at the sleepy island airport, I thought, there’s got to be a better way.
To keep Lyme off our backs, that is. Medical speak tells us that Lyme disease is a vector-borne illness caused by the Borreliabacteria that’s transmitted to humans by infected Ixodes ticks. We know it locally as the scourge of the Northeast from Virginia to Maine—the reason our kids can no longer roll laughing down grassy hills, and why our stomachs turn at the thought of strolling romantically through waving meadows a la vintage Merchant & Ivory films (the kiss scene amid hip-high Italian poppies in A Room with a View is ruined forever—thanks, Borrelia). According to the US Centers for Disease Control and Prevention (CDC), about 476,000 Americans may get Lyme disease each year, and incidence is growing in endemic regions of the US and Europe. That’s a lot of misery depending on the stage of infection—if left untreated after flu-like early symptoms, Lyme can spread to the joints, heart, and nervous system.
Yet one day, we might be able to saunter less fearfully again through the woods and unmown fields. And that is not the stuff of fantasy, but of science. Two promising new preventive therapies, both currently in clinical studies, could potentially stop Lyme in its tracks. One is a preexposure prophylaxis, or PrEP, shot developed by MassBiologics, to be taken annually at the start of tick season for months-long protection. The other is a vaccine candidate, VLA15, developed by French biotech firm Valneva in collaboration with Pfizer, the American multinational firm behind the Pfizer-BioNTech mRNA vaccine for COVID-19. If all continues to go well in the trials, both could come to market as early as 2024, offering two protective options to an arsenal against Lyme that has been nearly empty for decades.
Zapping Borrelia While It’s Still Inside the Tick
Way back when, we did have a vaccine for Lyme. Manufactured by SmithKline Beecham (now GlaxoSmithKline) in 1998, the LYMErix vaccine may have been ahead of its time, as it met with lackluster demand from consumers. The company pulled the vaccine in 2002, and some trace its failure back to the newly vocal anti-vax movement, which focused on reports that LYMErix may have triggered rheumatoid arthritis in a small population of patients. Since then, cases of Lyme have at least tripled, per CDC estimates. Yet while LYMErix faltered commercially, the science behind it offered clues that continue to help crack the nut of Lyme preventative medicine today. These clues have aided in the development of both Lyme PrEP, which is not a vaccine but a monoclonal-antibody shot, and the VLA15 vaccine candidate, which just might meet with more enthusiastic consumer demand this time around.
“During the vaccine studies back in the 1990s, it became apparent that the thing that allowed you to be protected and immune was an antibody directed against the [Borrelia] bacteria, and it didn’t work in you—it worked inside the tick,” explains Mark Klempner, MD, executive vice chancellor for MassBiologics and a professor of medicine. That is, LYMErix prompted the body to make antibodies against a protein on the surface of Borrelia called outer surface protein A (OspA). So, when a tick bit an immunized person, it feasted on blood containing Lyme-killing antibodies—which wiped out the bacteria sitting in the tick’s gut before it even entered the person’s body. Klempner and his colleagues set about finding a way to replicate that mechanism, while avoiding the potential pitfalls of a vaccine. “We knew the vaccine worked through an antibody that your body made, and we thought it would be a lot easier and safer to bypass that and give you the antibody directly,” he says. “That’s how we proceeded to look for our human monoclonal antibody that would kill the bacteria in the tick.”
The result was Lyme PrEP, which is designed to work immediately and provide protection against Lyme for the crucial six to nine months when ticks plague us, from about April through November. A phase 1 human trial is well underway, but don’t get excited about joining the study—yet. “To make it most likely that we’ll find volunteers with no previous antibodies to Lyme disease, we go to a place where there’s virtually no Lyme disease, and that is a place in Nebraska,” says Klempner. For the next phase, they’ll seek volunteers in Lyme-endemic spots like New England and the Hudson Valley, and Klempner knows those opportunities will fill up quickly. “I get emails and letters every day saying, ‘When you’re ready, sign me up.’”
Desperate Enough to Drink Twig TeaIt’s no wonder that people are eager to help advance the science of Lyme. In New York, most of us either have our own Lyme war story or we’ve got family or friends who’ve struggled with the illness. For Colette Stock, a registered nurse in Lake Hill, the saga began back in 1994, when she was a young mother in nursing school. “That summer, I had flu-like symptoms but I didn’t think anything of it, because Lyme wasn’t prevalent in Ulster County at the time,” she recalls. “I put the pieces together later, remembering that I’d walked through a swampy area, and about six weeks afterwards my daughter had found a round rash on the back of my head. Unfortunately, it took me a while to get diagnosed, and by that time it was already invested in my neurological system. Once that happens, Lyme can become chronic.”
Then came a procession of strange symptoms: pain between her shoulder blades, heart palpitations, dizziness, extreme fatigue. “In December, this excruciating pain set in, and I started to feel like I couldn’t walk,” she says. “I’d be in bed four to six hours a day. I would get up to make sure that [my daughter] had what she needed and then go back to bed.” Doctors doubted her story, sometimes accusing her of seeking pain pills (which she never took), or telling her she was depressed. “A lot of the doctors I went to were totally uneducated with regard to Lyme,” she says. “You have to go to a Lyme-literate [integrative medicine] doctor, and they don’t take insurance. I would go for a round of IV antibiotics and they’d give me a $600 bill, and I had to do it three times a week. You also take supplements and try alternative treatments that are expensive, too.” Once she visited an itinerant healer in Vermont who gave her a bag of twigs and told her to make a tea and drink it three times. “It looked like he went into the woods and just picked up a handful of twigs. And the tea smelled so bad,” she recalls. “But you get so desperate to feel better. You try anything.”
Stock estimates that she’s spent well over $150,000 on treatments over the years. She’s been in and out of remission several times and was reinfected in 2005 when she contracted babesia, a Lyme coinfection. She’s technically in remission after a successful round of IV antibiotics three years ago, but she still occasionally suffers from joint pain, weakness, and brain fog. “I can’t work because of my symptoms but I can’t collect disability, which I’ve applied for numerous times,” she says. “That’s because the CDC will not recognize chronic Lyme as a thing, which is pathetic.”
Fist-Pumping Enthusiasm for Lyme Science
Thankfully, many scientists do recognize acute and chronic Lyme disease as the public health crises they are—and they’re working hard to come up with solutions. The VLA15 vaccine candidate developed by Valneva and Pfizer targets six of the most common Borrelia strains found in the US and Europe. LYMErix targeted only one strain, which may explain why its efficacy rate was only about 76 percent after three doses of the vaccine. And as a precautionary measure against potential autoimmune side effects like rheumatoid arthritis, Valneva replaced LYMErix’s human-protein-mimicking segment of the OspA protein with a similar sequence from another strain. Just how effective the vaccine will be remains to be seen after its phase 2 trials, which include both adult and pediatric volunteers.
Finding kids to participate in clinical trials isn’t always easy, but with the heightened awareness and growing concern about Lyme, it hasn’t been a hurdle here. “Obviously, there are still a lot of parents who say, ‘I’d rather have somebody else do it, and then once it’s approved, I’ll get my kids vaccinated,’” says Jeffrey Stein, president of Stamford Therapeutics Consortium, one of several research companies conducting clinical trials for VLA15. “But if we all took that attitude then we’d never have any new drugs. We’re fortunate we’re able to reach people who are open-minded and willing to help in the way that they are.” Stein adds that the kids participating are every bit as motivated as their parents. They have to be comfortable with getting an injection three times, and having their blood drawn periodically to monitor their antibody levels. “A lot of them are outdoors kids, and they really want to help with this. We’ve got one young lady who’s 13, and every time she leaves, she sticks her hand up in the air and says, ‘For science!’”
Vaccine hesitancy is real, and time will tell how it affects the public’s embrace of a new Lyme vaccine. As for the Lyme PrEP shot, the fact that it’s not a vaccine may work in its favor. “There’s not a lot of preconceived monoclonal antibody hesitancy,” says Klempner, noting that monoclonal antibodies have been around as both a prevention and therapy for over 20 years. One, called Synagis, has been administered to hundreds of thousands of premature babies to prevent a lethal respiratory viral infection—and it’s been proven safe and effective over two decades. “It gives me a lot of confidence,” adds Klempner, “to think that something similar being used to prevent Lyme disease won’t have any untoward side effects that you would anticipate going forward.” Another advantage of Lyme PrEP: It requires only one shot instead of three, and it works immediately, while a vaccine needs several months in your system to build immunity.
Assuming that all goes well in the clinical trials and the shots are affordable (or better, covered by insurance), we still have a two- to three-year wait for both Lyme PrEP and VLA15. Until then, it’s essential to stay vigilant. A Lyme long-hauler as well as a nurse, Stock recommends always carrying a tick removal kit (note to self: add to vacation packing list), pulling them out with a slow, steady motion (note to daughter: no fingernails), and placing removed ticks in a zip-locked plastic bag so you can mail them out for testing. Services like TickReport.com, based in Massachusetts, will test the little critter for Lyme along with coinfections like bartonella, ehrlichiosis, and babesia. If you do get infected, be sure to visit a doctor who is Lyme-literate (not all of them are).
Along with Lyme PrEP and VLA15, Stock has heard of other Lyme remedies in development that use the mRNA technology we know from COVID-19 vaccines, as well as new antiviral protocols that may prove effective. “It makes you hopeful for the future,” she says, “but the thing is, the ticks are getting worse every year. We need to know how to stop this.”