April 26, 2022 – Valneva SE, a specialty vaccine company, and Pfizer reported positive Phase 2 pediatric data for their Lyme disease vaccine candidate, VLA15. Based on these new results, Valneva and Pfizer plan to proceed with inclusion of pediatric participants in their planned Phase 3 trial. The trial will evaluate VLA15 in adults and pediatric subjects 5 years of age and above and is expected to be initiated in the third quarter of 2022, subject to regulatory approval.
The Phase 2 trial, VLA15-221, is the first clinical study with VLA15 which enrolled a pediatric population (5-17 years old). It compared the immunogenicity and safety of VLA15 after administration of two (at months 0 and 6) or three (at months 0, 2 and 6) primary series doses in groups aged 5-11, 12-17 and 18-65 years. 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. This data builds on the strong immunogenicity profile already reported for adult participants (18-65 years old) in February 20221. 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.
Valneva and Pfizer plan to submit these data for publication and presentation at a future scientific congress.