Source:

Press Release

Disclosures: Jansen and Jaramillo report no relevant financial disclosures.
December 28, 2020
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Valneva to study Lyme disease vaccine candidate in children

Source:

Press Release

Disclosures: Jansen and Jaramillo report no relevant financial disclosures.
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Valneva this month announced plans to begin studying its Lyme vaccine candidate, VLA15, in children starting in the first quarter of 2021.

It will be the first time the vaccine, which is being co-developed and commercialized with Pfizer, will be studied in a pediatric population.

The study will include participants aged 5 to 65 years and will compare a reduced immunization schedule of two doses in 6 months with a three-dose, 6-month regimen.

“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 simplied schedule,” Pfizer Senior Vice President and Head of Vaccine Research and Development Kathrin Jansen, PhD, said in a news release.

The study — called VLA15-221 — will complement two ongoing phase 2 studies,VLA15-201 and VLA15-202, which have already reported positive data, Valneva said.

Data from the VLA15-221 trial are expected by the second quarter of 2022. The trial will also explore the administration of a booster dose, which would be administered 1 year after the 6-month dose.

According to Valneva, all three phase 2 trials are anticipated to support a phase 3 pivotal efficacy trial, which will include all main target populations for the Lyme disease vaccine candidate starting in 2022.

“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,” Valneva Chief Medical Officer Juan Carlos Jaramillo, MD, said in a news release. “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 said the first dose given in the new study will trigger a $10 million payout from Pfizer.

There has not been a licensed vaccine against Lyme disease in the United States since LYMERix was discontinued by GlaxoSmithKline in 2002.