SAINT-HERBLAIN, France—Valneva SE has announced plans to accelerate pediatric development of its Lyme vaccine candidate, VLA15, in its collaboration with Pfizer Inc. The companies plan to initiate the VLA15-221 study in the first quarter of 2021, subject to approval.
“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,” said Kathrin Jansen, senior vice president and head of Pfizer Vaccine Research and Development.
VLA15 covers six serotypes prevalent in North America and Europe. The investigational multivalent protein subunit vaccine targets the outer surface protein A (OspA) of Borrelia — one of the most dominant surface proteins expressed by Borrelia when present in a tick.
The Phase 2 VLA15-221 study currently plans to include about 600 healthy participants aged 5-65 years, who will receive 180µg of VLA15 — a dose selected based on data generated in two ongoing Phase 2 studies. If approved, this will be the first clinical study of VLA15 to enroll a pediatric population aged 5-17. The study will also compare the three-dose vaccination schedule Month 0-2-6 with a reduced two-dose schedule of Month 0-6.
“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,” noted Juan Carlos Jaramillo, M.D., chief medical officer of Valneva.
The VLA15-221 study will complement the two ongoing Phase 2 studies, VLA15-201 and VLA15-202. Initial data from study VLA15-221 are expected by the second quarter of 2022. VLA15-221 is also expected to investigate a booster dose of VLA15, administered one year following the 6 month dose. Valneva believes that all three trials will support a Phase 3 pivotal efficacy trial in all main target populations for the Lyme vaccine candidate, beginning in 2022.
Back in April, Valneva and Pfizer entered into a collaboration agreement to co-develop and commercialize VLA15. Under the terms of the agreement, the first subject dosed in this study will trigger a milestone payment of $10 million from Pfizer to Valneva. Valneva’s original plan, prior to the agreement with Pfizer, assumed age deescalation after the vaccine was licensed. Pfizer’s involvement has allowed for this pediatric development acceleration.
In other vaccine news from Valneva, the company recently reported a vaccine partnership with the UK government for its inactivated COVID-19 vaccine, VLA2001. If vaccine development is successful, Valneva will provide the UK government with 60 million doses in the second half of 2021. The UK government also has options of over 40 million doses in 2022, and a further 30 to 90 million doses in aggregate across 2023 to 2025. Revenue from these options could amount to almost €900 million.
“We made the early decision to choose a proven and well-established inactivated vaccine approach, which is further validated by this partnership,” stated Thomas Lingelbach, chief executive officer of Valneva, in a press release. “We are honored to have been chosen by the UK Government and are eager to partner with them to address this terrible ongoing pandemic.”
Valneva’s inactivated SARS-CoV-2 vaccine is expected to have a two dose regimen. The UK government is also investing up-front in the scale up and development of the vaccine, with their investment to be recouped against the vaccine supply under the partnership agreement.
U.K. Business Secretary Alok Sharma concluded, “I have seen first-hand the incredible work they are doing to develop and manufacture a COVID-19 vaccine. This new agreement could help us vaccinate millions of people across the country, as well as help create a UK vaccine manufacturing facility to speed up access to a potential COVID-19 candidate and boost the country’s resilience against future pandemics.”
VLA2001 is expected to enter clinical studies at the end of 2020.