Valneva Announces Acceleration of Pediatric Development for Lyme Disease Vaccine Candidate

IndustryPRwire – Valneva SE announced its plans to accelerate pediatric development of its Lyme vaccine candidate, VLA15, in collaboration with Pfizer, with the planned initiation of study VLA15-221 in the first quarter of 2021, subject to regulatory approval.

VLA15-221 is planned as a randomized, observer-blind, placebo-controlled Phase 2 study. Currently, the study will include approximately 600 healthy participants (5-65 years of age) who will receive VLA15 at the dose of 180µg, which was selected based on recent data generated in the two ongoing Phase 2 studies.

If approved, it will be the first clinical study of VLA15 to enroll a pediatric population aged 5-17 years and will compare the three-dose vaccination schedule Month 0-2-6 with a reduced two-dose schedule of Month 0-6.

Kathrin Jansen, Senior Vice President and Head of Pfizer Vaccine Research and Development Commented “This will be an important study that we anticipate will provide evidence that the vaccine can be used in the populations that are at risk of the devastating consequences of Lyme disease, using a simplified schedule.”

This study will complement the two ongoing Phase 2 studies VLA15-201 (initial positive data reported on 22nd July 2020) and VLA15-202 (initial positive data reported on 20th October 2020). Initial data from study VLA15-221 (primary endpoint) are expected by the second quarter of 2022. VLA15-221 will also investigate a booster dose of VLA15, administered one year following the 6 Month dose. All three Phase 2 trials are anticipated to support a Phase 3 pivotal efficacy trial including all main target populations for the Lyme vaccine candidate starting in 2022.

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva commented “We believe that including the pediatric population early on could provide support for the Phase 3 study to include all major target groups for our future Lyme vaccine candidate and may potentially support successful market access including respective recommendations. We are pleased that Pfizer and Valneva have decided to accelerate this development step while preparing for a potential Phase 3 start, expected in 2022.”

Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop and commercialize VLA15.

Under the terms of the agreement, first subject, first dose in this study will trigger a milestone payment of $10 million from Pfizer to Valneva. The original Valneva plan, prior to the Pfizer agreement, assumed age de-escalation post-licensure. The Pfizer collaboration allows acceleration of pediatric development.

About VLA15

VLA15 is the only active Lyme disease vaccine in clinical development today, and covers six serotypes that are prevalent in North America and Europe. This investigational multivalent protein subunit vaccine targets the outer surface protein A (OspA) of Borrelia, an established mechanism of action for a Lyme disease vaccine. OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick. VLA15 has demonstrated promising immunogenicity and safety data in pre-clinical and clinical studies so far. The program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 2017.

Valneva and Pfizer announced a collaboration for VLA15’s development and commercialization at the end of April 2020. The two companies are working closely together on the next development steps.

About Clinical Study VLA15-221

VLA15-221 is a randomized, observer-blind, placebo controlled Phase 2 study. It is the first clinical study with VLA15 that will enroll a pediatric population aged 5 years and older.

A total of approximately 600 participants will receive VLA15 at two different immunization schedules (Month 0-2-6 or Month 0-6, 200 volunteers each) or placebo (Month 0-2-6, 200 volunteers). The main safety and immunogenicity readout (Primary Endpoint analysis) is anticipated at Month 7, where peak antibody titers are expected. A subset of participants will receive a booster dose of VLA15 or placebo at Month 18 (Booster Phase) and will be followed for three further years to monitor the antibody persistence.

VLA15 will be tested as an alum-adjuvanted formulation and administered intramuscularly. The study will be conducted at sites which are located in areas where Lyme disease is endemic and will enroll volunteers with a cleared past infection with Borrelia burgdorferi, the bacteria that cause Lyme disease, as well as B. burgdorferi naïve volunteers.

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