Health
Final trial of new vaccine to prevent Lyme disease begins
Vaccine protects 5-year-olds from infection Lyme disease According to a statement by vaccine developer Pfizer and French pharmaceutical company Valneva.
trial, Vaccine Against Lyme for Outdoor Recreation (VALOR) To investigate the efficacy, safety, and immunogenicity of VLA15, an investigational Lyme disease vaccine candidate.
“We are very pleased to have reached this important milestone in the development of VLA15. It represents a need release“We look forward to further investigating the VLA15 candidates in Phase 3.
“I think it’s great that we get new Lyme disease vaccine — I think it’s important to have it, especially in an environment where there are so many opportunities to take chances. tick bite It can transmit disease.” Dr. Mark Soroski, Professor Emeritus of Molecular Microbiology and Immunology at Johns Hopkins School of Medicine, Baltimore, and has conducted Lyme disease research. “The data from the Phase 1 and Phase 2 trials are encouraging,” he adds.
New Lyme disease vaccine ‘for a long time’
If Phase 3 trials are successful and the vaccine is approved, it will be the only Lyme disease vaccine available for humans in the United States. However, the company says the process will take several more years and has no plans to seek vaccine approval until 2025.
A new vaccine for Lyme disease “has been around for a while,” Dr. Soloski says. “There was a vaccine that was withdrawn from the market in the 1990s. That vaccine, called LYMERix, was discontinued 20 years ago by him due to some reported side effects. National Institute of Allergy and Infectious Diseases.
An analysis by the U.S. Food and Drug Administration found no evidence to support these reports, but sales of the vaccine plummeted and the manufacturer chose to discontinue production.
New vaccine designed to reduce potential side effects
This new vaccine has a similar mechanism of action to the discontinued vaccine. It also targets OspA, a cell outer surface protein. Borrelia Bacteria that cause Lyme disease. This inhibits the bacteria’s ability to leave the tick and infect humans.
But the new vaccine is designed differently, says Soloski. “Some of the proteins thought to cause serious side effects, such as promoting arthritis and other types of musculoskeletal ailments, have been removed,” he says.
The incidence of Lyme disease has nearly doubled in the last 30 years
Lyme disease is the most common vector-borne disease in the United States, affecting an estimated 476,000 people in the United States. Centers for Disease Control and Prevention (CDC)130,000 in Europe, researchThe incidence of Lyme disease has nearly doubled in the last 30 years. U.S. Environmental Protection Agency (EPA) A link to climate change.
disease is caused by bacteria Borrelia burgdorferi and, rarely, Borrelia MayonyHumans are infected by being bitten by an infected black-legged tick. CDC.
Symptoms include fever, headache, fatigue, and characteristic skin rash It is called erythema migrans. Lyme disease is diagnosed based on symptoms, physical findings, and presence or absence of tick exposure. Lab testing is useful when used correctly and performed in a validated manner.
If diagnosed early, most cases of Lyme disease can be successfully treated with a few weeks of antibiotics. If left untreated, the infection can spread to the joints, heart and nervous system.
About 6,000 people are expected to enroll in the new trial
The randomized, placebo-controlled, Phase 3 trial will enroll approximately 6,000 participants aged 5 years and older. The study is being conducted at up to 50 different sites in areas where Lyme disease is highly prevalent, including Finland, Germany, the Netherlands, Poland, Sweden, and several states in the United States.
Participants will receive 3 doses of vaccine or saline placebo as a primary vaccination series, followed by 1 booster dose of VLA15 or saline placebo. Researchers will follow participants to see if the vaccine safely stimulates immunity in spontaneous outbreaks of Lyme disease.
“If approved, the vaccine will be voluntary. It will be someone’s personal choice,” Soroski says. People who choose to be vaccinated against Lyme disease include those who live in states such as New England and Maryland, those who work outdoors in construction, gardening, or agriculture, and those who frequently hike or camp. there is a possibility. he says.of CDC provides information on its website to help you determine risk.
An estimated 10-15% of people with Lyme disease continue to have symptoms after treatment
A few person with Lyme disease While many return to good health after diagnosis and treatment, others still have persistent symptoms, says Soloski. This vaccine will really benefit those people,” he says.
It is estimated that approximately 10-15% of people with Lyme disease have “post-treatment Lyme disease (PTLD)”. john hopkins medicine“These people may have cognitive problems, sleep problems, vision problems, brain fog, pain, and fatigue. That way, you’re not one of these individuals,” Soloski said.
Other Potential Lyme Disease Vaccines and Prevention Tools in the Pipeline
In addition to vaccines from Pfizer and Varneva, there are other potential treatments and vaccines in the pipeline designed to protect people from Lyme disease, says Soloski. We’ve developed a monoclonal antibody that can prevent tick bites from transmitting the bacteria that cause Lyme disease,” he says. According to one person, that shot could be available as early as 2024 for him. UMass Chan Medical School Released.
Another vaccine, still in its early stages, is working on a vaccine that would immunize people against all tick bites, not just black-legged ticks, Soloski says. This is important because it also protects against many other tick-borne diseases,” he says.
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