Pfizer/Valneva

Pfizer, Valneva report positive trial results for Lyme disease vaccine candidate

September 8, 2023

On Thursday, September 7, Pfizer and Valneva announced that phase 2 study results for their VLA15 Lyme disease vaccine candidate showed a strong anamnestic antibody response for all serotypes in pediatric (5 to 11 years of age) and adolescent participants (12 to 17 years of age), as well as in adults (18 to 65 years of age), one month after administration of a booster dose.

• Depending on the primary schedule they received (month 0-2-6 or month 0-6), participants seroconverted after the booster dose, yielding seroconversion rates of 95.3% and 94.6% for all outer surface protein A serotypes in all age groups, respectively. 
• Outer surface protein A antibody titers were significantly higher one month after the booster dose compared with one month after the primary schedule with 3.3- to 3.7-fold increases (Geometric Mean Fold Rises) in adults, 2.0- to 2.7- fold increases in adolescents, and 2.3- to 2.5-fold increases in children for all serotypes.
• The safety and tolerability profile of VLA15 after a booster dose was consistent with previous studies; the vaccine candidate was well-tolerated in all age groups regardless of the primary vaccination schedule.
• No vaccine-related serious adverse events and no safety concerns were observed by an independent Data Safety Monitoring Board.

Pfizer says it intends to submit regulatory applications for VLA15 to both the FDA and the European Medicines Agency in 2026 if the phase 3 clinical trial, launched last year, yields positive results.

Source:

(2023, September 7). Valneva SE and Pfizer Inc. Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate. https://valneva.com/press-release/valneva-and-pfizer-report-positive-pediatric-and-adolescent-phase-2-booster-results-for-lyme-disease-vaccine-candidate/