Pfizer Inc. (PFE) and Valneva SE (VALN) reported Thursday six-month antibody persistence data for Lyme disease vaccine candidate VLA15 in both children and adults.
VLA15 is the only vaccine candidate currently in clinical development for Lyme disease, a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by infected Ixodes ticks.
The companies noted that this is the first time antibody persistence data are reported in pediatric populations for this vaccine candidate.
Valneva and Pfizer, following positive immunogenicity and safety data for Phase 2 study VLA15-221 in April 2022, evaluated the persistence of antibodies six months after the three-dose Month 0-2-6 and the two-dose Month 0-6 vaccination schedule with VLA15 in healthy adults and pediatric participants, from 5 to 65 years of age.
Data were collected in 96 healthy adults and 81 pediatric participants from 5-17 years of age for the Month 0-2-6 vaccination schedule. Further, for the Month 0-6 schedule, data were collected in 84 healthy adults and 78 pediatric participants.
The companies noted that, as observed in previous clinical studies with VLA15, antibody levels declined over time in all study groups but remained above baseline. This confirms their persistence six months after completion of both vaccination schedules.
Overall, antibody levels remained higher with the three-dose vaccination schedule compared to the two-dose schedule.
These results further validate the use of the three-dose vaccination schedule which is also included in the Phase 3 protocols for all participants.
The companies did not observe any vaccine-related serious adverse events and any safety concerns in this six-month observational follow up.
Pending successful completion of the Phase 3 studies, Pfizer could potentially submit a Biologics License Application or BLA to the U.S. Food and Drug Administration and Marketing Authorisation Application to the European Medicines Agency in 2025.
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