📢 Pfizer and Valneva have completed the enrollment in Phase 3 VALOR trial for their Lyme borreliosis vaccine candidate, VLA15. The trial included over 9,000 participants and aims to confirm the efficacy and safety of the vaccine. Lyme disease is the most common vector-borne infectious disease in the US and Europe. A vaccine could prevent the disease and its long-lasting consequences. Approval is expected not before 2026.
📢 Valnevas Lyme vaccine trial completes recruitment
Introduction:
Valneva SE and Pfizer Inc. have announced the completion of enrollment in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) Phase 3 trial of their investigational Lyme disease vaccine candidate VLA15. The trial aims to confirm the efficacy, safety, batch consistency, and immunogenicity of VLA15.
Main points:
- The VALOR trial enrolled 9,437 participants of age five and older at sites in areas highly endemic for Lyme disease in the U.S., Europe, and Canada.
- Participants received three doses of VLA15 or a saline placebo within the first year and one booster dose approximately one year after completion of the primary immunization.
- VLA15 has demonstrated a strong immune response and a favorable safety profile in pre-clinical and clinical trials, with no vaccine-related serious adverse events or safety concerns.
- A second Phase 3 trial is also fully recruited, aiming to provide further evidence on the safety profile of VLA15 in the pediatric population.
- If approved, the vaccine could prevent Lyme disease and reduce the burden of acute and long-lasting consequences in both adults and children.
Conclusion:
The completion of enrollment in the VALOR trial is an important milestone in the development of a potential vaccine for Lyme disease. VLA15 has shown promising results in terms of immune response and safety, and if approved, it could have a significant impact on reducing the incidence and consequences of Lyme disease.
