Products

Date: 2017-07-24

Type of information: Granting of a Fast Track status

Product name: VLA15

Compound: Lyme borreliosis vaccine

Therapeutic area: Infectious diseases

Action mechanism:  vaccine. VLA15 is a new hexavalent, protein subunit-based vaccine candidate targeting the Outer Surface Protein A (OspA) of Borrelia, the most dominant protein expressed by the bacteria when present in a tick. By targeting the most prevalent serotypes of Borrelia and blocking the transmission of these Lyme-causing bacteria from the tick to the host, the vaccine has the potential to protect from Borrelia infection in the U.S., Europe, and potentially worldwide.

Company: Valneva (France - Austria)

Disease: Lyme disease

Latest news:

• • On July 24, 2017, Valneva announced that the FDA has granted Fast Track designation for its Lyme disease vaccine candidate VLA15. The target indication is the active prophylactic immunization against Lyme disease in children and adults. Valneva recently completed subject enrollment for the ongoing Phase I study of its Lyme disease vaccine candidate. The study is being conducted at three sites – two in the U.S. and one in Europe (Belgium) – combining approximately 180 subjects aged between 18 and 40 years. The primary objective of the observer-blind, partially randomized, dose escalation study is to evaluate the vaccine candidate´s safety and tolerability profile at different dose levels and formulations. Valneva expects to announce first results in Q1 2018 and plans to initiate a Phase II trial in Q1 2018.

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Is general: Yes