Valneva has reported final safety and immunogenicity findings from the randomised Phase II trial, VLA15-221, assessing the Lyme disease vaccine candidate VLA15.
The infectious condition is caused by the Borrelia burgdorferi bacterium, which is passed to humans through bites from infected Ixodes ticks.
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The findings demonstrated a robust anamnestic immune response and favourable safety profile across all age groups six months post a third booster dose.
As per earlier study observations, an extra dose led to an increase in antibody levels, which decreased gradually but stayed higher than baseline across all groups, demonstrating their continued presence at month 48, six months post the vaccination given at month 42.
The observer-blind, placebo-controlled VLA15-221 trial claims to be the first to include paediatric participants aged five to 17 years.
A total of 560 healthy individuals were given either VLA15 in two immunisation schedules (month 0-2-6 or month 0-6) or placebo.
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By GlobalDataThe selected dose was 180µg, based on previous Phase II studies’ data.
The primary endpoint was assessed one month post the primary vaccination series. Eligible participants were given annual boosters at months 18, 30, and 42, with antibody persistence monitored up to six months after the third booster.
VLA15 was administered intramuscularly as an alum-adjuvanted formulation. The trial was carried out at sites in the US where Lyme disease is prevalent and included volunteers with and without prior Borrelia burgdorferi infection.
Valneva and Pfizer partnered for VLA15’s development and commercialisation in April 2020.
Pending positive Phase III data, Pfizer plans to submit regulatory applications to the US Food and Drug Administration and the European Medicines Agency in 2026.
Valneva chief medical officer Juan Carlos Jaramillo said: “Lyme disease continues to expand geographically and remains a pressing unmet medical need affecting communities across the Northern Hemisphere.
“Each set of positive results moves us closer to the possibility of making this vaccine available to adults, adolescents and children living in Lyme-endemic areas.”
