A Lyme disease vaccine candidate for adults and children at least 5 years old produced strong immunogenicity, safety and overall positive results this week in a Phase 2 trial conducted by its developers, Valneva SE and Pfizer Inc.
This marked the first clinical study where VLA15, as the candidate is known, enrolled a pediatric population. Both the vaccine’s safety and tolerability statistics were similar for the 5 to 17 year old participants as they were for adults. Neither group faced serious adverse events during testing.
As a result, VLA15 will be tested more on children for a broader Phase 3 trial expected to start in the third quarter of this year, subject to regulatory approval.
“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,” Dr. Juan Carlos Jaramillo, chief medical officer of Valneva, said. “These first pediatric results are therefore extremely important and support the inclusion of pediatric participants in our planned Phase 3 trial. In partnership with Pfizer, we are excited to further investigate our VLA15 vaccine candidate, which will hopefully help protect both adults and children against Lyme disease.”
For the Phase 2 trial, immunogenicity and safety was compared after administration of two and three doses of the candidate, with doses spaced 6 months apart for the first case, and at months 0, 2 and 6 months for the second. The candidate was found to be more immunogenic than it was in adults during both schedules. Going forward, the companies agreed the data showed that a three-dose primary vaccination schedule would be pursued for Phase 3.
“The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens,” Dr. Kathrin U. Jansen, senior vice president and head of vaccine research and development at Pfizer, said. “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.”
Valneva and Pfizer intend to submit data from the randomized, placebo-controlled Phase 2 trial for publication at a later date.