Lyme Research
Mark Eggena, MD, PhD, PBMC regional chief medical officer, joined the trial and received his vaccine shot from Logan Clark, CMA, Neurology, as part of the Lyme vaccine clinical study.
Progress Made on Vaccine for Lyme Disease
According to the Centers for Disease Control and Prevention, vaccine development can often take 10-15 years. There is one disease in particular that has a 20 year history of vaccine development with a few false starts: Lyme disease.
MaineHealth is a part of this long-awaited clinical trial which is occurring at Pen Bay Medical Center (PMBC). Pfizer Pharmaceutical is the sponsor of the trial which is underway in Europe and the US.
PBMC is the only MaineHealth hospital and one of only two sites in Maine participating in the study, which is evaluating if a Lyme vaccine is safe and effective for preventing Lyme disease in people who have been exposed through tick bites. The research team includes Dr. Robert Stein, PMBC neurologist and Medical Director of Clinical Research at PMBC, who is the Principal Investigator, Dr. Robert Smith, infectious disease physician and Director of the Vector-borne Disease Lab at MHIR, who is an affiliated investigator and Caroline Knight, RN, BSN, CCRP, who is the Clinical Research Nurse Coordinator for the study.
Lyme disease is a common illness caused by bacteria found in deer ticks. If left untreated, Lyme disease can progress to cause severe, sometimes permanent symptoms. Currently, there are no approved vaccines available for humans to prevent Lyme disease.
Two Year Study
In the trial, 50% of participants receive the Lyme vaccine while 50% will receive a placebo. The investigational vaccine mechanism works by pre-emptively blocking a surface protein of the bacteria in the feeding tick during the time it takes to infect someone after the bite. Blocking the surface protein inhibits the bacterium’s ability to leave the tick and infect humans. The study will take place over approximately two years, during which time participants will receive a total of four immunizations and five blood draws over the course of seven visits.
Study participants are healthy adults aged 18 and older who had not been diagnosed with Lyme disease in the three months prior to enrollment. All enrolled participants live, work, or recreate in areas prone to ticks.
If the vaccine is effective, the next step is going through the Federal Drug Administrative (FDA) process for approval. “It’s really exciting to see commercial interest in getting a Lyme vaccine after such a long time,” said Dr. Stein. “Our next challenge will be deciding the criteria for who will benefit most from the vaccine if approved. Thankfully antibiotic treatment is effective for treating Lyme disease, but a vaccine would preempt the infection from the start.”
