There Lyme diseaseis an infectious disease caused by the bacterium Borrelia transmitted to humans by infected ticks. Early symptoms of the disease (erythematous rash or other less specific disease symptoms such as fatigue, fever, headache, neck stiffness, arthralgia or myalgia) are often overlooked or misdiagnosed. If detected late, the infection can cause severe joint, heart or central nervous system complications. Each year, approximately 300,000 Americans and 85,000 Europeans develop Lyme disease.
To fight against this scourge, researchers from the French laboratory Valneva have developed a vaccine, VLA15, which targets the outer surface of protein A (OspA) of Borrelia, one of the proteins most expressed by the bacterium when it is present in a tick. The clinical trial of the vaccine is moved to phase 3announced Pfizer and Valneva on August 8, 2022. This is the last phase before authorization requests marketing, which aims to evaluate the efficacy, safety and immunogenicity of their vaccine candidate against Lyme disease.
Entitled VALOR, the study “randomized, placebo-controlled trial is expected to enroll approximately 6,000 participants aged 5 years and older“, indicates a press release from Valneva. This study will beconducted at up to 50 sites located in areas where Lyme disease is highly endemic, including Finland, Germany, the Netherlands, Poland, Sweden and the United States“, he ends. The previous phase, carried out on 246 people, had demonstrated the effectiveness of the vaccine on all populations and had not triggered any adverse effects.
A vaccine approved by the US FDA
VLA15, the only vaccine candidate in clinical development against Lyme disease, received “Fast Track” status from the Food and Drug Administration (FDA), the US federal drug agency, in 2017. This status is reserved for products in development targeting serious diseases and having the potential to address an unmet medical need. This generally leads to a faster obtaining of a marketing authorization.
“Lyme disease affects an increasing number of people each year, many of whom must live with long-term sequelae that are not only extremely difficult to treat but also represent a significant economic burden. We are honored to advance the only Lyme disease vaccine currently in clinical development and look forward to working closely with the FDA and other health authorities to facilitate the development of this vaccine toward marketing authorization. market“, had declared at the time the CEO of Valneva.
- Valneva and Pfizer launch a Phase 3 study for their Lyme disease vaccine candidate VLA15, ValnevaAugust 8, 2022
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