Lyme disease vaccine candidate enters phase 3 trial
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Pfizer and Valneva announced the start of a phase 3 trial that will study the safety and efficacy of their Lyme disease vaccine candidate, VLA15.
“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, PhD, senior vice president and head of vaccine research and development at Pfizer, said in a press release.
The randomized, placebo-controlled, phase 3 study called VALOR will enroll approximately 6,000 participants aged 5 years or older at up to 50 sites in areas where Lyme disease is highly endemic, including Finland, Germany, the Netherlands, Poland, Sweden and the United States.
According to the press release, participants will be randomly assigned in a 1:1 ratio to receive three doses of VLA15 180 g or saline placebo as a primary vaccination series — with the second and third doses coming at 2 months and 5 to 9 months — followed by a booster dose of VLA15 or saline placebo around 12 months later.
“We hope that the data generated from the phase 3 study will further support the positive evidence for VLA15 to date,” Anderson said.
Despite a high burden, here has not been a licensed vaccine against Lyme disease in the U.S. since GlaxoSmithKline discontinued LYMERix 2002, citing insufficient consumer demand.
Existing phase 2 data demonstrate VLA15’s “strong immunogenicity” and “acceptable safety and tolerability profiles” in adults and children, the companies said. Positive VALOR study data could lead to a biologics license application to the FDA and a marketing authorization application to the European Medicines Agency in 2025, they said.
Eugene D. Shapiro, MD, professor of pediatrics and epidemiology at the Yale School of Medicine, told Healio that the VLA15 is “likely to be a good, effective vaccine.”
“It’s very similar to the previous vaccine that was withdrawn from the market” — with one advantage, Shapiro said.
He noted that VLA15 covers the six most common serotypes of Borrelia burgdorferi present in North America and Europe, whereas LYMERix was only effective against one.
“In Europe, it's probably only a third or so of [Lyme disease] caused by the strain that causes virtually all disease in the U.S. This new vaccine includes those additional strains,” Shapiro said.
Because of this and because of an increased awareness of Lyme disease, as well as the potential recommendation for the vaccine’s use in endemic areas where people are at an increased risk for tick bites, Shapiro believes there will be greater demand for this vaccine than there was for LYMERix, despite any general antivaccine sentiment that may spill over.
“It's important to be aware of the potential risk of getting Lyme disease,” Shapiro said. “If the vaccine is shown to be safe and effective, which I suspect it will be, it's another good tool in our armamentarium.”
References:
CDC. Lyme disease. https://www.cdc.gov/lyme/prev/vaccine.html. Accessed on Aug. 10, 2022.
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