Pfizer along with a French partner have announced the largest clinical trial for an experimental vaccine that could be the only way to stop Lyme disease, the two companies announced on Monday.
If the vaccine is found to be reliable and safe the vaccine, now known as VLA15 is an important tool for stopping the tick-borne illness that affects approximately half one million Americans every year. Although most people can get rid of the disease through a course of antibiotics, some suffer for years with persistent symptoms.
The initial signs of a potentially dangerous tick bite could be a rash of bulls-eye and fever, fatigue and headache. It can also cause muscles that hurt and a stiff neck. If not treated properly, Lyme can cause arthritis or heart problems and can affect your nervous system.
A prior Lyme treatment, LYMErix, was taken off the market in 2002 following concerns over its safety, which were never proven and slowed public interest. The manufacturer, GlaxoSmithKline, withdrew it.
The study, in partnership with French company Valneva, is expected to enrol around 6000 volunteers between the ages of 5 on more than 50 locations in several countries in which Lyme is a major issue including Lyme-related illnesses in the United States.
VLA15 is given in three doses that are and then an additional booster. Half of the participants will be given placebo saline for the first three doses, and half will receive the saline-based placebo as an extra dose The company stated.
The vaccine is a targeted attack on an outer layer protein in Borrelia burgdorferi bacteria, which causes Lyme disease. Blocking this protein may hinder the ability of the bacteria to leap from person to tick.
The vaccine is protected against six types of protein that are produced by bacteria that live within North America as well as Europe.
In the earlier tests, both in individuals and in labs and in labs, this vaccine “demonstrated a strong immune response and satisfactory safety profile,” the companies stated.
If this Phase 3 trial goes well it is likely that the companies will file a request for approval by the Food and Drug Administration in 2025.
“With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important than ever,” Annaliesa Anderson who is Pfizer’s senior vice-president and director of vaccine research and development stated in an announcement. “We hope that the data generated from the Phase 3 study will further support the positive evidence for VLA15 to date.”
Pfizer has agreed to pay an initial payment of $25 million to Valneva when the trial begins on Monday. Both companies have been working on the creation of the vaccine since the beginning of April.