Pediatric Lyme disease vaccine study launches at Rutgers University
😷 Rutgers is taking part in a pediatric Lyme disease vaccine study
😷 The trial is enrolling 50 to 100 children ages 5 to 17
😷 Participants must not have been diagnosed with Lyme in the past three months
NEW BRUNSWICK — Rutgers University is participating in the effort to determine the safety and efficacy of what could be the first vaccine to prevent Lyme disease in children.
The Pediatric Clinical Research Center at Rutgers Robert Wood Johnson Medical School in New Brunswick is one of 50 research sites nationwide, and the only clinical trial site in New Jersey.
What is Lyme disease?
Lyme disease is an infection caused by a bacteria carried by the deer tick, which, when it bites people, can spread infection, said Dr. Sunanda Gaur, professor of Pediatrics Infectious Diseases and director of the Pediatric Clinical Research Center at Rutgers RWJ Medical School.
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, she said.
Anywhere from 3,500 to 5,000 cases of Lyme occur in New Jersey every year. Currently, there are no approved vaccines to prevent the disease, she said.
What problems can Lyme disease cause?
Dr. Gaur said a rash is usually the first symptom of Lyme disease. People may also experience headaches, head stiffness, joint pain and swelling, and fatigue. It can also affect the heart, the brain, and other organs of the body, and in many cases, these symptoms can last a very long time.
What is the clinical vaccine trial all about?
The vaccine is made up of parts of the protein of the bacteria, so it is not a live vaccine, Dr. Gahr said. Rutgers was selected for the national research study by drug company, Pfizer and French vaccine maker, Valneva SE to evaluate the safety and efficacy of the vaccine for the prevention of Lyme in children between the ages of 5 and 17.
The vaccine will be given in four doses over the course of a year to a year and a half.
“After all those doses are completed, we hope it will provide 70 to 80 percent protection against getting the disease. Just like any other vaccine, once you get the vaccine, it leads to the formation of antibodies in a person,” Dr. Gaur said.
The research center is enrolling 50 to 100 children who have not been diagnosed with Lyme disease in the past three months for the two-year study, which will include 3,000 children, she said.
They also should never have had Lyme arthritis or joint infection from the Lyme bacteria.
Three out of four participants who meet the eligibility requirement will be provided vaccine doses while the fourth will receive a placebo or a dummy dose, she explained.
“The idea is to make sure the vaccine is firstly safe, and certainly the effectiveness is also being studied,” Dr. Gaur said.
Participants will be required to have six follow-up visits with the study team, where there will be clinical evaluation as well as two follow-up phone calls over the course of the study.
Why is this vaccine important?
New Jersey is one of the high-risk states for Lyme disease, Dr. Gaur said. The number of cases is on the rise.
“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,” Dr. Gaur said.
Children are most at risk during the spring and summer months when ticks are most active.
Those who are interested in taking part in the Lyme disease vaccine clinical trial, can get more information here.
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