Valneva and Pfizer have announced another Phase 2 trial for its Lyme Disease vaccine. Currently known only as VLA15, the vaccine is the only one currently in development and covers the six most common types of Lyme Disease found in North America and Europe. If approved, the vaccine could protect millions of patients worldwide from this life-limiting condition.
The tell-tale symptoms of Lyme Disease are a large, ‘bulls-eye rash and feelings of fatigue, nausea, headache and stiff neck. Diagnosis is challenging, but if left untreated, Lyme Disease can cause severe complications to the joints (arthritis), heart and nervous system.
Lyme Disease is an infection caused when certain types of bacteria are transferred to humans by infected ticks. The disease affects an estimated half a million patients every year in the US (300,000) and Europe (200,000). The impact of climate change, including warmer, milder winters, mean that ticks – and the disease they carry – are spreading, increasing the risk of Lyme Disease infection.
After a successful Phase 1 trial, the VLA15 vaccine was fast-tracked by the US FDA in 2017, which recognised its importance. Phase 2 is a randomised, observer-blind, placebo-controlled trial. A group of 600 participants will be split into three groups: a placebo group and two groups who will be immunised at different times.
The vaccine targets the outer surface protein A (OspA) of Borrelia. OspA is the most dominant surface protection expressed by the bacteria, and scientists have long recognised its potential for providing protection.
The trial’s purpose is to establish the efficacy of the vaccine and provide more information on the most effective dosing schedule, explains Kathrin Jansen, Senior Vice President and Head of Pfizer Vaccine Research and Development. “This will be an important study that we anticipate will provide evidence that the vaccine can be used in the populations that are at risk of the devastating consequences of Lyme disease, using a simplified schedule.”
For the first time, the vaccine will be trialled in children aged five years and above. It’s a bold step, but one that’s critical to establishing the safety of the vaccines, says Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva: “We believe that including the pediatric population early on could provide support for the Phase 3 study to include all major target groups for our future Lyme vaccine candidate and may potentially support successful market access including respective recommendations.”
The current trial is one of three Phase 2 trials currently being performed by Pfizer and Vallneva. All three Phase 2 trials are anticipated to support a Phase 3 pivotal efficacy trial including all main target populations for the Lyme vaccine candidate starting in 2022, said Valneva and Pfizer in a joint press release.
Perhaps for the first time, the exciting trials offer the prospect of a safe and effective vaccine for Lyme Disease. While the rapid developments in trials are exciting, it’s unlikely we’ll see the vaccine available for several years.
Until a Lyme Disease vaccine becomes available, early diagnosis and treatment remain the most effective strategy. At Biocentaur, we offer a range of personalised medical tests that can accurately diagnose Lyme Disease. Our sensitive PaldiSpot genetic test can detect the presence of Borrelia, Babesia and Bartonella genospecies in a DNA sample.
Learn more about the Biocentaur range of tests here.