Valnevas Lyme vaccine trial completes recruitment

Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) and Pfizer Inc. announced that they have completed enrollment in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) Phase 3 trial (NCT05477524) of their investigational Lyme disease vaccine candidate VLA15. The trial builds on previous positive Phase 1 and 2 results and includes both adult and paediatric participants and is designed to confirm the efficacy, safety, batch consistency and immunogenicity of VLA15.

“We are pleased to have completed enrolment in the Phase 3 trial. Lyme disease is the most common vector-borne infectious disease in the United States and Europe, and can sometimes have long-lasting consequences,” said Annaliesa Anderson, M.D., Senior Vice President and Head of Vaccine Research and Development at Pfizer.

The VALOR trial, which was initiated in August 2022, has enrolled 9,437 participants five years of age and older, at sites in areas where Lyme disease is highly endemic across the U.S., Europe and Canada. As part of the primary series, participants receive three doses of VLA15 or a saline placebo (1:1 ratio) within the first year, and one booster dose approximately one year after completion of the primary immunization.

The VLA15 candidate has demonstrated a strong immune response and had a favorable safety profile across all dose and age groups in pre-clinical and clinical trials according to the companies. No vaccine-related serious adverse events (SAEs) and no safety concerns were observed by an independent Data Safety Monitoring Board (DSMB). A second Phase 3 trial (C4601012), aiming to provide further evidence on the safety profile of VLA15 in the pediatric population, is also fully recruited.

Dr Juan Carlos Jaramillo, Valneva’s Chief Medical Officer, said: “The completion of enrolment is indeed an important milestone in the development of a potential vaccine for Lyme disease. VLA15 has the potential to address a high unmet need in North America and Europe as it is designed to provide coverage against the most common circulating Borrelia species causing Lyme disease in these regions.”

If approved, a vaccine could prevent the disease and reduce the burden of acute, severe and sometimes permanent sequelae in both adults and children. Submitting of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) is expected not before 2026, and of course subject to positive data.