USA – Valneva, a specialty vaccine company, and Pfizer Inc. have announced additional positive Phase 2 results for Lyme disease vaccine candidate VLA15, including a booster response.
Valneva and Pfizer had announced a collaboration for the development and commercialization of VLA15. With phase 2 trials breakthrough, the two companies are collaborating closely on the next development steps, with a Phase 3 trial planned for 2022.
VLA15 is a multivalent protein subunit vaccine that targets Borrelia’s outer surface protein A (OspA) knocking the bacteria out before the tick can transmit them to humans.
This vaccine is intended to protect people against the 6 known strains of the Lyme disease bacterium.
There is currently no vaccine available for Lyme disease. The manufacturer discontinued the only vaccine previously marketed in the United States, LYMERix, in 2002, citing insufficient consumer demand.
LYMErix was a three-dose human regimen introduced about twenty years ago by SmithKline Beecham, the forerunner to the pharmaceutical giant GlaxoSmithKline.
This vaccine’s protection is said to deteriorate over time, thus any person who received the vaccine in 2002 is probably no longer protected.
Lyme disease is a systemic infection caused by the bacteria Borrelia burgdorferi, which is spread to humans through the bite of infected blacklegged ticks, commonly known as a deer tick.
It is regarded as the most common vector-borne disease in the Northern Hemisphere, presenting a high unmet medical need, which impacts the lives of millions of people in the region, with an expanding prevalence and geographical reach.
“The prevalence and geographic reach of Lyme disease is growing, underscoring the major medical need for vaccination against the disease,” noted Kathrin Jansen, PhD, Senior Vice President and Head of Pfizer Vaccine Research and Development.
“These positive results of the Phase 2 VLA15-202 study represent another important milestone in the development of VLA15, and we look forward to continue our development efforts in our quest to potentially protect people from Lyme disease in the future,” she added.
The medical need for vaccination against Lyme disease is steadily increasing as the disease footprint widens.
The burden of Lyme disease is expanding globally, and current prevention options are insufficient to reverse course.
A course of antibiotics, typically doxycycline, form the standard treatment for Lyme disease. Ideally, the medication should be taken within a few days of infection, but this is difficult to achieve.
According to the Centers for Disease Control and Prevention (CDC), approximately 476,000 Americans are diagnosed and treated for Lyme disease each year, with at least 200,000 cases occurring in Europe each year.
Meanwhile, MassBiologics, a division of the University of Massachusetts Medical School, has developed a human monoclonal antibody for use as pre-exposure prophylaxis (PrEP) for Lyme disease and human trials are set to start soon.
This strategy, if it succeeds would offer seasonal protection against Lyme disease. It would most likely consist of a single-shot given to people each year at the start of tick season.