Pfizer Reports Positive Phase 2 Data for Lyme Disease Vaccine
The Lyme disease vaccine candidate elicited a similar safety and tolerability profile in patients aged 5–17-years old as adult participants in previous studies.
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By - Pfizer and Valneva recently reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15.
The Phase 2 trial, VLA15-221, is the first clinical study with VLA15 that enrolled a pediatric population aged 5–17 years old. Researchers compared the immunogenicity and safety of the vaccine candidate after administering two or three primary series doses in three separate groups.
The first group included patients aged 5–11 years old, the second group included patients aged 12–17 years old, and the third group included patients aged 18–65 years old. VLA15 was more immunogenetic than in adults for all vaccination schedules.
The safety and tolerability profile observed in patients aged 5–17-years old was similar to the previously reported profile in adult participants. Researchers observed no vaccine-related serious adverse events.
Pfizer and Valneva plan to submit these data for publication and presentation at a future scientific congress.
“The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens,” Kathrin U. Jansen, PhD, senior vice president and head of vaccine research and development at Pfizer, said in the announcement.
“These positive pediatric data mark an important step forward in the ongoing development of VLA15, and we are excited to continue working with Valneva to potentially help protect both adults and children from Lyme disease,” Jansen continued.
VLA15 is currently the only active Lyme disease vaccine program in clinical development and covers six serotypes prevalent in North America and Europe. The multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of the bacteria that cause Lyme disease.
In July 2017, FDA granted VLA15 Fast Track designation.
Juan Carlos Jaramillo, MD, chief medical officer of Valneva, noted that Lyme disease affects all age groups, but with their affinity for being active outdoors, the pediatric population is at the greatest risk of Lyme disease.
“We are excited to further investigate our VLA15 vaccine candidate, which will hopefully help protect both adults and children against Lyme disease,” Jaramillo continued.
