Lyme Disease Vaccine on the Fast Track

The U.S. Food and Drug Administration (FDA) has granted ‘Fast Track’ designation for a Lyme disease vaccine candidate called VLA15.

Lyme disease is caused by the bacterium Borrelia burgdorferi and is transmitted to humans through the bite of infected blacklegged ticks.

A new predictive modeling study found the overall risk of contracting Lyme disease from a deer tick bite is 2.6%.

Moreover, the risk increases with tick engorgement, tick attachment time, and detection of Borrelia burgdorferi DNA in ticks. Ticks that tested positive for Borrelia DNA posed a five times higher hazard than Borrelia-negative ticks.

VLA15 is a new hexavalent, protein subunit-based vaccine candidate targeting the Outer Surface Protein A (OspA) of Borrelia.

Fast Track designation is granted by the FDA to products that are under development for serious conditions and have the potential to fulfill an unmet medical need.

Pre-clinical data showed that the VLA15 vaccine candidate had the potential to provide protection against the majority of Borrelia species pathogenic for humans.

There is currently no Lyme borreliosis vaccine available for humans.

Research has shown that the disease can be prevented by immunization with an OspA-based vaccine (LYMErix). LYMErix, was approved by the FDA in 1998. LYMErix vaccine efficacy was only 80% against Lyme disease. Moreover, it required three doses over a 12-month period.

LYMErix was withdrawn from the market in 2002.

According to the Centers For Disease Control and Prevention (CDC), studies suggest that the number of people diagnosed with Lyme disease each year in the United States is around 300,000. Lyme disease cases are concentrated in the Northeast and upper Midwest, with 96% of cases reported.

Lyme disease is diagnosed based on symptoms, physical findings (e.g., rash), and the possibility of exposure to infected ticks. Laboratory testing is helpful if used correctly and performed with validated methods.

Most cases of Lyme disease can be treated successfully with a few weeks of antibiotics. Antibiotics commonly used for oral treatment include doxycycline, amoxicillin, or cefuroxime axetil.

Thomas Lingelbach, President and CEO of Valneva, the producer of VLA15, commented, "Lyme disease affects an increasing number of people each year, many of whom have to live with long-term sequelae that are not only extremely difficult to treat but also represent a heavy health economic burden."

Valneva recently completed subject enrollment for the ongoing Phase I study of its Lyme disease vaccine candidate. The company plans to initiate Phase II for VLA15 as early as the first quarter of 2018.

Immunogenicity, measured by observing IgG antibodies against the six most prevalent serotypes of Lyme borreliosis in the US and Europe present in the vaccine, will also be monitored for different dose groups and formulations at different time-points.

Valneva is a fully integrated, commercial stage biotech company focused on developing innovative life saving vaccines. Valneva offers two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC.

More information is available at www.valneva.com