- 9,437* participants enrolled at sites across the U.S., Europe and Canada in areas where Lyme disease is endemic
- Trial conclusion expected by year-end 2025
- Pfizer aims to submit regulatory filings in the U.S. and Europe in 2026
New York, NY, and Saint-Herblain (France), December 4, 2023 - Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that they have completed recruitment for the Phase 3 trial Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) for Lyme disease vaccine candidate VLA15. The trial builds on previous positive Phase 1 and 2 trial results and includes both adult and pediatric participants, with the aim to confirm the efficacy, safety, lot consistency, and immunogenicity of VLA15.
"We are pleased that the Phase 3 trial recruitment is complete. Lyme disease is the most prevalent vector-borne infectious disease in the United States and Europe, can sometimes even lead to long lasting consequences," said Annaliesa Anderson, Ph.D., Senior Vice President and Head Vaccine Research and Development, Pfizer. "If approved, a vaccine could prevent the disease and ease the burden of acute, severe and sometimes persistent consequences in both adults and children. We look forward to progressing the trial with the goal of submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2026, subject to positive data."
Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said: "The completion of enrollment is indeed an important milestone in the development of a potential vaccine for Lyme disease. VLA15 has the potential to address a high need in North America and Europe, as it has been designed to offer coverage for the most common circulating types of Borrelia bacteria that cause Lyme disease in these regions. We're excited about the ongoing trials and the progress towards potentially offering a vaccine against this disease which can result in debilitating sequelae and excessive healthcare usage."
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 so far.1,2 No vaccine-related serious adverse events (SAEs) and no safety concerns were observed by an independent Data Safety Monitoring Board (DSMB).1,2 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.
The VALOR trial is expected to be concluded by the end of 2025. Pfizer and Valneva entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.3,4
About VLA15
There are currently no approved human vaccines for Lyme disease, and VLA15 is the most advanced Lyme disease vaccine candidate currently in clinical development, with two Phase 3 trials in progress. This investigational multivalent protein subunit vaccine uses an established mechanism of action for a Lyme disease vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. OspA is a surface protein expressed by the bacteria when present in a tick. Blocking OspA inhibits the bacterium's ability to leave the tick and infect humans. The vaccine candidate covers the six most common OspA serotypes expressed by the Borrelia burgdorferi sensu lato species that are prevalent in North America and Europe. VLA15 is an alum-adjuvanted formulation, administered intramuscularly and has demonstrated a strong immune response as well as satisfactory safety profile in pre-clinical and clinical trials so far.
About the VALOR trial
VALOR is an ongoing randomized, observer-blind, placebo-controlled Phase 3 trial which has enrolled 9,437* participants 5 years of age and older to receive VLA15 or a saline placebo (1:1 ratio). As part of the primary series, participants receive three doses of VLA15 within the first year at months 0, 2 and 5-9, and one booster dose 9-12 months after completion of the primary immunization.5 The final primary series vaccination for participants occurs just before the peak Lyme disease season for the region. Participants will be followed for the occurrence of Lyme disease. The trial is conducted at sites located in areas where Lyme disease is highly endemic across the U.S., Canada and Europe and has enrolled volunteers with a cleared past infection with Borrelia burgdorferi as well as Borrelia burgdorferi naïve volunteers.
About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by the bite of an infected Ixodes ticks.6 It is considered the most common vector-borne illness in the Northern Hemisphere.7,8 While the true incidence of Lyme disease is unknown, it is estimated to annually affect approximately 476,000 people in the U.S. and 129,000 people in Europe.8,9 Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called Erythema migrans or more nonspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia or myalgia) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious chronic complications affecting the skin, joints (arthritis), the heart (carditis) or the nervous system.9,10 The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.11
* Number of evaluable participants
