A new vaccine candidate by Pfizer and Valneva for Lyme disease has entered Phase 3 of a clinical trial, bringing new hope to limit the disease in the future.
The trial, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), is investigating the efficacy, safety and immunogenicity of the vaccine candidate, VLA15. The Phase 3 trial enrolled 6,000 participants aged 5 and older, and it is a randomized, placebo-controlled study taking place at up to 50 local sites in areas where Lyme disease is highly endemic, such as Finland, Germany, the Netherlands, Poland, Sweden and the United States.
The development is an exciting one for Lyme disease, which is transmitted to humans through the bite of infected blackleg ticks and is the most common vector-borne disease in the United States, according to the Centers for Disease Control and Prevention (CDC). The disease is characterized by fever, headache, fatigue, and a characteristic skin rash called erythema migrans, and, if left untreated, the infection can spread to joints, the heart and the nervous system. In the U.S. alone, approximately 476,000 people may get Lyme disease each year, according to recent estimates from the CDC.
“With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important than ever,” Annaliesa Anderson, PhD, senior vice president and head of vaccine research & development at Pfizer, said in a statement. “We hope that the data generated from the Phase 3 study will further support the positive evidence for VLA15 to date, and we are looking forward to collaborating with the research sites across the U.S. and Europe on this important trial."
Participants in the trial will receive three doses of the vaccine or a placebo, followed by one booster shot or placebo. Phase 2 of the trial revealed strong immunogenicity in adults as well as in children and acceptable safety and tolerability among both. If the Phase 3 trial is also successful, Pfizer could submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025, the company said.
Upon initiation of the Phase 3 trial, Pfizer will pay Valneza $25 million, per the terms of the collaboration agreement between the two companies. News of the trial comes just a day after Pfizer confirmed it is acquiring Global Blood Therapeutics for a whopping $5.4 billion.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."