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Upstate seeking participants for a pediatric Lyme disease vaccine clinical trial

Upstate Medical University is seeking participants for a pediatric Lyme disease vaccine clinical trial.

Run by Upstate’s Institute for Global Health and Translation Science, this trial supports a larger Phase 3 trial by Pfizer and Valneva that started last fall and is being performed at several sites in the United States and overseas. This study includes participants from ages 5 to 65.

Upstate is specifically looking for a minimum of 100 participants ages 12 to 17 for the two-year study. Four shots will be given, either placebo or vaccine. There are no blood draws planned for this study, and there is compensation for participant and adult guardian. To enroll or for more information, contact the Global Health Research Unit at (315)-464-9869 or [email protected].

Kristopher Paolino, MD, assistant professor of microbiology and immunology and Director of Institute for Global Health and Translational Science, said Upstate’s study, an offshoot of the main study, will only be looking at the pediatric population. 

Paolino specializes in Lyme disease care and said an increasing number of ticks in New York are found to be carrying Lyme and other diseases. The tick surveillance program at Upstate has tested more than 27,000 ticks since it began in 2019, and about a third of those ticks have been found to carry one or more pathogens or disease-causing organisms.

“We live in an endemic area for Lyme disease, with more ticks being found to be positive for Lyme in our region, resulting in increased numbers of patients,” he said. “Lyme is the most important vector borne disease in the United States with an estimated 500,000 infections annually. The ticks are not going anywhere so our best chance to fight this infection is to maximize preventive measures. In addition to personal protective measures (topical repellants, tick checks, permethrin treated clothing, etc.), an effective vaccine will help prevent infections when other measures fall short.”

Upstate will launch a Multidisciplinary Lyme and Tick-Borne Disease Treatment Center, thanks to a recent federal grant to better treat patients infected by ticks.

The national study will look to enroll 3,000 subjects from ages 5-17, with a younger group of 5-11 years old, and an older group of 12-17 years old, the latter of which Upstate will be supporting, Paolino said. 

“This will add to the safety data that will be collected as part of the main Pfizer trial that started last Fall in 2022,” he said.