Lyme Disease Vaccine Study Launched

Rutgers has been selected as a clinical trial site for the national research study by drug company Pfizer Inc. and French vaccine maker Valneva SE to evaluate the safety and efficacy of a vaccine for the prevention of Lyme disease in children over the age of 5.

Lyme disease is caused by a bacterium called Borrelia burgdorferi that is transferred to humans through the bite of an infected tick. If left untreated, the bacteria can spread through the bloodstream and cause serious problems in the brain, joints and heart. According to the Centers for Disease Control and Prevention, about 476,000 Americans are diagnosed and treated for Lyme disease, which is more common in children and teens. Currently, there are no approved vaccines to prevent Lyme disease.

The Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School in New Brunswick — one of approximately 50 research sites nationwide and the only clinical trial site in New Jersey — is enrolling 50 to 100 children ages 5 to 17 who have not been diagnosed with Lyme disease in the past three months for the two-year study, which will include 3,000 children.

Three out of four participants who meet the eligibility requirements for the study will be provided doses of the vaccine while one-fourth will receive a placebo. Three doses will be given in the first six months, with a booster shot one year later.

Participants will be required to have six follow-up visits with the study team in New Brunswick, where there will be clinical evaluation as well as blood tests and two follow-up phone calls over the course of the study.

“Developing a vaccine is important because currently the only prevention is protecting children from tick bites through clothing and insect repellant and then checking them for ticks after they play outside, especially if they are in the woods or in grassy areas,” said Sunanda Gaur, director of the Pediatric Clinical Research Center. “They are most at risk during the spring and summer when ticks are most active.”

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