Lyme Disease Vaccine Enters Phase 3 Trial
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Pfizer and biotech company Valneva announced they had launched the phase 3 trial for a Lyme disease vaccine. If it doesn’t work, these companies plan to apply for an official Lyme vaccine approval in 2025, as NPR reports. If approved, it will be the only human Lyme disease vaccine.
A Lyme vaccine could be a vital public health tool to fight against the spreading of the disease. Lyme disease cases in the United States have doubled since 1991, and the ticks who carry it spill over into new territory, caused partly by climate change.
Ticks and Lyme Disease
The CDC estimates there are around 476,000 people who are diagnosed and treated for Lyme disease each year. Still, there is doubt about that estimate: some people who are treated presumably, as other infections could be overlooked.
In areas of New England, where Lyme was first discovered, over 15% of the population now has antibodies from a Lyme disease infection.
The infection is produced by a circular-shaped bacterium named Borrelia burgdorferi, whose name contradicts the wicked disease.
After the infected tick bites someone, the bacteria can take its time to work itself in. As a result, the initial symptoms, such as aches, chills, fever, and fatigue, may appear in days or weeks.
These symptoms are typically accompanied by Lyme disease trademark: a slight circular rash in a bullseye shape. The bullseye inflammation is easily identifiable, but about 30% of Lyme cases do not develop the target-looking rash, as some may lack this signature outer ring, making diagnosing it very challenging.
If Lyme is missed and then treated, it may cause severe neck, joint, and head pain, irregular heartbeat, and spinal cord and brain inflammation.
A Lyme disease vaccine has not been available in the United States for over 20 years since a vaccine made by SmithKline Beecham (SKB) was discontinued.
The New Lyme Vaccine
The new vaccine study, Vaccine Against Lyme disease for Outdoor Recreationists (VALOR), will occur across 50 sites where Lyme is “highly endemic” across Europe and US.
This new Lyme vaccine works to aim for a protein the bacteria express on its outer shell while in ticks.
By blocking the protein’s target, this Lyme inoculation hopes to prevent the bacteria from ever leaving the tick, thus keeping away the infection. In addition, this shot aims for the six most common types of this protein, triggering an immune response from multiple strains of Lyme.
Pfizer is looking to enroll about 6,000 people starting from age five and older in this study. One group will get three doses of the Lyme disease vaccine — the second and third shots given two months and 5-9 months after the first vaccine — followed up with one booster shot one year later, while the other group will get placebo injections instead.
The Lyme disease vaccine will be evaluated by comparing rates of Lyme cases that were confirmed in the placebo and vaccine groups and antibody testing to find instances that might have been missed.
The first run of these three vaccines starts before Lyme season, which occurs in late spring, with the booster to follow in the next year’s Lyme disease season. The study will plan to end by December 31, 2024.