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Lyme disease on the move (2014)
03:29 - Source: CNN
CNN  — 

Vaccine maker Pfizer says it has begun Phase 3 clinical trial of its vaccine candidate against Lyme disease with French vaccine company Valneva SE.

The biotech companies are recruiting about 6,000 participants age 5 and older at up to 50 sites in areas of Europe and the US where Lyme disease is endemic, they said Monday in a news release.

The participants will get three doses of the vaccine, called VLA15, or a placebo, followed by a booster dose.

“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, senior vice president and head of vaccine research and development at Pfizer, said in the news release.

VLA15 is the only Lyme vaccine in clinical development, Pfizer said in the statement. It targets the bacteria Borrelia burdorferi, the main cause of the tick-borne disease, and has “demonstrated a strong immune response and satisfactory safety profile in pre-clinical and clinical studies so far.”

If the trial shows that the vaccine is safe and effective, Pfizer says, it could submit requests for approval from the US Food and Drug Administration and the European Medicines Agency in 2025.

What is Lyme disease?

Lyme disease is the most common vector-borne disease in the US, according to the US Centers for Disease Control and Prevention, and it’s becoming common in more areas.

An estimated 476,000 Americans are diagnosed and treated for Lyme disease each year, although the CDC says this is probably an overcount because people are sometimes treated without official confirmation that they have the disease.

The only vaccine previously marketed in the US was discontinued in 2002.

Lyme disease symptoms

Fever, chills, body aches, swollen lymph nodes, neck stiffness, shortness of breath, headache, fatigue and a rash are all typical symptoms of Lyme disease.

When you get bit by a tick, you will typically see a small red bump that may look like a mosquito bite. But three to 30 days later, if a rash shows up and expands from that red area and looks a little like a bull’s-eye, that’s a sign you may have Lyme disease.