FDA decision driven by early Phase 1 trial results for VLA15.
Lyme disease, caused by the bacteria Borrelia burgdorferi spirochetes, is a growing problem in the US. According to the U.S. Centers For Disease Control and Prevention (CDC), nearly 30,000 confirmed and probable cases of lyme disease were documented in the US in 2015, up from just over 23,000 cases in 2005. That makes lyme disease the fastest-growing vector-borne infection in the country, and currently there is no vaccine to protect against the disease.
There is hope, however. The US Food and Drug Administration in July 2017 awarded Fast Track designation to a developmental vaccine named VLA15. Positive results for Valneva’s candidate in a Phase I clinical trial led to the agency’s acceleration of its clinical testing.
The company reported on positive Phase 1 interim data for VLA15 in March 2018 and recently announced that it expects to launch a Phase 2 study in the second half of 2018. The study will be performed in regions of the US and Europe where Lyme disease is endemic and include already infected patients. The dose and schedule for the treatment is currently being determined.
Valneva did indicate that as part of its development acceleration strategy it was adding a booster dose to augment its Phase I study. A group of initial participants in the Phase I trial that received three vaccinations – the complete primary immunization schedule - will receive a booster extension approximately thirteen months after the first immunization in order to investigate the safety, immunogenicity and effectiveness of booster administration. Analysis of safety and immunogenicity will be determined once all participants have received their last study visits, which will take place six months after the booster shots are received.