After years of hopes and false starts for a new Lyme disease vaccine, a candidate vaccine will be tested for safety in humans. Valneva, a French company, has received US Food and Drug Administration and European Union Clinical Trial Application approval to conduct a Phase I trial in 180 adults in sites in both the United States (Lincoln, Nebraska) and Europe (Ghent, Belgium). A pre-clinical trial of the vaccine candidate showed that it was effective at preventing Lyme disease in mice. The proposed dosage is a three-dose series at 0, 1-2, and 12 months, with a booster after 3-5 years. If the vaccine safety profile is acceptable in the Phase I trial, it would then proceed to a Phase II efficacy trial.
The vaccine candidate has many similarities to the SmithKlineBeecham/GSK vaccine that was withdrawn from the US market in 2002. Like the original vaccine, the Valneva candidate is based on a lipoprotein from the outer surface of Borrelia bacteria – a protein called OspA – that stimulates a protective immune response. Unlike the earlier vaccine, however, the new vaccine protects against six different Borrelia OspA serotypes, including those that cause most disease in the United States and in Europe. At the time that the first US Lyme disease vaccine was withdrawn, GSK was nearing approval for a vaccine based on the most common Lyme-disease-causing bacteria in Europe. This single vaccine could unite both the US and European markets for the first time. Valneva says the potential market is about $500 million a year. A study conducted by researchers at Johns Hopkins University Bloomberg School of Public Health estimated that US treatment costs for Lyme disease are about $1.3 billion a year.
In its press materials announcing the clinical trial, Valneva points to a study that exonerates the previous vaccine of causing arthritis and Lyme-disease-like symptoms in recipients. These allegations and accompanying lawsuits were in large part responsible for the withdrawal of the earlier vaccine from the market.
Valneva’s portfolio includes a Clostridium difficile vaccine in clinical trial, a Zika virus vaccine candidate in pre-clinical trial, as well as licensed cholera and Japanese encephalitis vaccines.
Adrion ER, Aucott J, Lemke KW, Weiner JP. Health care costs, utilization and patterns of care following Lyme disease. PLoS One. 2015.
The College of Physicians of Philadelphia. The history of the Lyme disease vaccine. HistoryofVaccines.org.
Comstedt P, Hanner M, Schüler W, Meinke A, Lundberg U. Design and development of a novel vaccine for protection against Lyme Borreliosis. PLoS ONE. 9(11): e113294. doi:10.1371/journal.pone.0113294
Mosher D. A new Lyme disease vaccine will soon be tested on humans. SFGate.com. 12/9/2016.
Plotkin SA. Need for a new Lyme disease vaccine. New Engl J Med. 2016; 375:911-913
Steere AC, Drouin EE, Glickstein LJ. Relationship between immunity to Borrelia burgdorferi outer-protein A (OspA) and Lyme arthritis. Clin Infect Dis. (2011) 52 (suppl 3): s259-s265.doi: 10.1093/cid/ciq117
Valneva. Valneva’s Lyme disease vaccine candidate VLA15. Downloaded from http://www.valneva.com/en/rd/vla15. 12/16/2016.