Valneva and Pfizer report positive Phase 2 data for Lyme disease vaccine in children
While Lyme disease can affect all age groups, their affinity for being active outdoors puts the pediatric population at greatest risk from the tick-borne bacteria. The disease is becoming of greater concern as changing climates help the geographic footprint of the disease widen.
The Phase 2 trial compared the immunogenicity and safety of VLA15 after administration across three age groups: 5-11, 12-17 and 18-65. Participants were either given a two dose (months 0 and 6) or three dose (0, 2 and 6) schedule.
“In pediatric participants (5-17 years old) who received VLA15 in either the two-dose schedule (N=93) or three-dose schedule (N=97), VLA15 was found to be more immunogenic than in adults with both vaccination schedules tested," report the companies.
Lyme disease is a systemic infection caused by Borreliaburgdorferi bacteria transmitted to humans by infected Ixodes ticks. It is considered the most common vector-borne illness in the Northern Hemisphere.
While the true incidence of Lyme disease is unknown, it is estimated to annually affect approximately 476,000 people in the US and 130,000 people in Europe.
"These data build on the strong immunogenicity profile already reported for adult participants (18-65 years old) in February 2022. Like in adults, the immunogenicity and safety data support a three-dose primary vaccination schedule in pediatric participants in the Phase 3 study.
“The safety and tolerability profile observed in the 5- to 17-year age group was similar to the previously reported profile in adult participants. No vaccine-related serious adverse events (SAEs) were observed.”
The Phase 3 trial is set to start in Q3 2022, subject to regulatory approval, evaluating VLA15 in adults and children aged 5+.