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Volunteers needed for Lyme vaccine trials

If it's approved, it would be the first Lyme-fighting vaccine in 20 years.

MAINE, Maine — Mainers still have a chance to volunteer to test a shot against Lyme disease. 

Pfizer and French company Valneva are developing the vaccine known as VLA15. If it's approved, it would be the first Lyme-fighting vaccine in 20 years. Enrollment for adults in the blind study is nearly full, but researchers need volunteers ages 5 to 18 to sign up, especially kids who spend a lot of time outdoors in tick-infested areas.

Phase 3 clinical trials of the world's only vaccine candidate against Lyme disease have been underway for several months. The companies hope to enroll 6,000 participants in mobile clinics across New England and other parts of the country.

Spead by a bite from a deer tick, Lyme can cause a rash, and symptoms can include fever, chills, and joint pain. If not treated quickly, serious conditions can occur. 

There are, however, some restrictions to participating in the trial.  

"If they have had a tick bite recently, then basically have to wait for a few weeks before they can enroll," Alex Eastman, the vice president of Care Access, a Boston-based company managing the clinics, said.  

He said people who had the one FDA-approved vaccine known as Lymerix, which was pulled in 2002 because of side effects, cannot enroll in the study. Also, slots for adults are nearly full. 

"We are getting close to the adult enrollment, but there is still an opportunity for kids or families with kids to participate," Eastman said. 

High enrollment in other states led to the cancellation of a planned clinic in South Portland. But volunteers can still travel to sites in Londonderry, New Hampshire, and Rockland, Massachusetts, which are the closest locations to Maine. There are also tentative plans to run a site out of a pediatrician's office in Farmington, but nothing has been finalized.  

"Hopefully eradicating and knocking down Lyme disease is this vaccine, in my opinion," Dr. Sean McCloy, a family medicine doctor who treats Lyme and tick-borne infections at the Integrative Health Center of Maine, said.

The vaccine clinic was originally going to be held in his office. 

McCloy encourages patients and parents to talk to their doctors before enrolling in the trial. 

In a news release earlier this month, both companies didn't report any serious side effects or safety issues from the first two phases of the trials.

"Participants aged 5 years of age and older will receive the VLA15 or a saline placebo," Pfizer spokesperson Keanna Ghavzini told NEWS CENTER Maine in a statement. "Participants will receive three doses of VLA15 as part of the primary series in the first year, and one booster dose approximately one year after completion of the primary immunization. Vaccination of participants will occur just before peak Lyme season for the region. The duration of the study will be 29 months." 

The shot contains three different proteins found in the pathogen that causes Lyme. 

"It's making your immune system get ready to attack that bacteria if you ever get a tick bite," Dr. McCloy added.  

For more information on the VLA15 from the U.S. Centers for Disease Control and Protection, visit this link.

Carleen Hoffman suffered from debilitating fatigue, pain, depression, and suicidal thoughts for 15 years, seeking help from numerous doctors before being diagnosed with late-stage Lyme. Most of her symptoms have improved, but she still has lingering issues. 

"There are some days when I am dead to the world. It's a tough situation," Hoffman said. 

Most of her symptoms have improved, but she still has lingering issues. She isn't ready to be part of the trials and questions the timing. 

"Why didn't this happen years ago?" Hoffman asked.

Anyone who is interested in enrolling can go here.

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