Researchers are looking for thousands of volunteers in the United States and Europe to test the first possible Lyme disease vaccine in 20 years in the hopes of better combating the tick-borne danger.
Lyme disease is becoming more common, with cases increasing as temperatures rise and ticks increase their range. While a Lyme disease vaccination for dogs has long been available, the sole Lyme disease vaccine for humans was taken from the market in 2002 due to a lack of demand, leaving individuals to depend on bug spray and tick inspections.
Now, Pfizer and the French company Valneva are attempting to avoid prior problems in the development of a novel vaccine to protect both adults and children as young as five years old against the most frequent Lyme strains on two continents.
The first time around, “there wasn’t such a realization, I believe, of the seriousness of Lyme disease” and how many people it impacts, Pfizer vaccine head Annaliesa Anderson told The Associated Press.
Robert Terwilliger, a hunter and hiker, was the first in line when the study began in central Pennsylvania on Friday. He’s watched several pals have Lyme disease and is weary of knowing whether his next tick bite would make him sick.
“It’s always a source of concern, you know? Especially if you’re sitting in a tree stand and feel anything crawling on you “Terwilliger, 60, of Williamsburg, Pennsylvania, said “You must use extreme caution.”
It’s unclear how often Lyme disease attacks. According to the Centers for Disease Control and Prevention, 476,000 individuals are treated for Lyme disease in the United States each year, based on insurance data. According to Anderson of Pfizer, the number of illnesses in Europe each year is about 130,000.
Lyme disease-causing germs are carried by black-legged ticks, often known as deer ticks. Initially, the infection produces weariness, fever, and joint discomfort. A red, circular bull’s-eye rash is often – but not always – the first indication.
Early antibiotic treatment is critical, but it may be difficult for individuals to identify whether they have been bitten by ticks, some of which are as little as a pin. Untreated Lyme disease may cause severe arthritis as well as heart and nervous system damage. Even after therapy, some patients have lasting effects.
Most vaccinations for various illnesses only function after individuals have been exposed to a pathogen. The Lyme vaccine takes a different approach, acting sooner to prevent a tick bite from spreading the virus, according to Dr. Gary Wormser, a Lyme specialist at Current York Medical College who was not involved in the new study.
How? It targets OspA, a “outer surface protein” of the Lyme bacteria found in the tick’s stomach. It is assumed that a tick must feed on its victim for around 36 hours before the bacterium spreads. This delay allows antibodies ingested by the tick from a vaccinated person’s blood to fight the germs directly at the source.
Pfizer and Valneva observed no safety issues and a positive immunological response in modest, early-stage investigations. The most recent research will determine if the vaccination, known as VLA15, really protects and is safe. The corporations want to hire at least 6,000 workers in Lyme-prone regions such as the Northeast United States, as well as Finland, Germany, the Netherlands, Poland, and Sweden.
Between now until next spring’s tick season, they’ll get three injections, one with the vaccine and one with a placebo. They’ll receive a single booster shot a year later.
“We’re looking at a seasonal vaccination,” Anderson added, so individuals have high antibody levels during the months when ticks are most active.
Volunteers as young as five years old should be at high risk since they spend a lot of time in tick-infested places, such as hikers, campers, and hunters, according to Dr. Alan Kivitz, director of one of the research sites at Altoona Center for Clinical Research in Duncansville, Pennsylvania.
“Not a single day goes by that someone either has a fear about Lyme disease, or might potentially have Lyme disease,” Kivitz said of his own practice.
This new candidate differs from a prior Lyme vaccine taken off the market by GlaxoSmithKline in 2002 due to controversy and poor sales. With an estimated 75 percent efficacy, the previous Lyme vaccine received a tepid recommendation from vaccine specialists, was never studied in children, and generated unconfirmed complaints of joint-related adverse effects.
While the new Pfizer-Valneva vaccine targets the OspA protein, it is designed differently than its predecessor and targets six Lyme strains in the United States and Europe rather of just one.
The Pfizer study will cover two tick seasons to get answers, but it is not the only study looking at novel methods to avoid Lyme disease. Scientists at the University of Massachusetts are developing a vaccine substitute: doses of pre-made Lyme-fighting antibodies.
In addition, Yale University researchers are in the early phases of developing a vaccine that identifies tick saliva, which in animal tests caused a skin response that made it difficult for ticks to attach and eat.
Because various tick species transmit a variety of illnesses in addition to Lyme disease, “we’re all looking for a tick-bite prevention vaccination,” Wormser said.