The pharmaceutical companies Pfizer and Valneva are currently developing a vaccine against tick-borne Lyme disease. A phase III study with 6,000 subjects in several countries will start soon.
With Pfizer and Valneva, two pharmaceutical companies are currently developing a vaccine against ticks transmitted Lyme disease. A randomized and placebo-controlled phase III study with 6,000 subjects aged 5 and over in areas where the Lyme-Borreliose is highly endemic including Finland, Germany, the Netherlands, Poland, Sweden and the USA.
Participants will receive three doses of the vaccine called VLA15 or a saline placebo as a primary series, followed by a booster dose of VLA15 or a saline placebo. According to a press release from Pfizer, the efficacy, safety and immunogenicity of the active substance are to be examined. Data from the Phase 2 studies demonstrate strong immunogenicity in both adults and children with acceptable safety and tolerability profiles.
Protein blockade prevents the Borrelia from leaving the tick
The multivalent protein subunit vaccine uses a mechanism of action that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that causes Lyme disease. OspA is a surface protein expressed by the bacteria when present in a tick.
Blocking OspA inhibits the bacterium’s ability to exit the tick and infect humans. The vaccine covers the six most common OspA serotypes expressed by the dominant Borrelia burgdorferi species in North America and Europe.
A vaccine against Lyme disease is being developed
If the phase III study of the vaccine developed against Lyme disease is successful, the companies could submit applications for approval to the US Food and Drug Administration and the European EMA in 2025.
Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by infected Ixodes ticks. The true incidence of Lyme disease is unknown, officially it affects about 476,000 people in the United States and 130,000 people in Europe each year.
Early symptoms are a gradually spreading rash (erythema migrans) or more nonspecific symptoms such as fatigue, fever, headache, mild neck stiffness, arthralgia, or myalgia. Left untreated, the disease can cause more serious complications affecting the joints (arthritis), the heart (carditis), or the nervous system.