The overall Phase 2 objective for VLA15 is to determine the optimal dosage level and schedule for use in Phase 3 pivotal field efficacy studies, based on immunogenicity and safety data.
The Phase 2 development for the Lyme disease vaccine candidate will include the evaluation of the highest dose of VLA15 tested in Phase 1 in addition to two higher doses. Furthermore, the company plans to include the evaluation of an additional, alternative three-dose schedule.
Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva, commented, “Lyme disease cases in the U.S. have increased dramatically over the last 30 years or so, substantially increasing the costs for healthcare systems. The fear of contracting Lyme disease diminishes the quality of life of people of all ages. As the disease footprint widens, the need for a vaccine to prevent this significant unmet medical need increases. Valneva is doing everything possible, in consultation with FDA and EMA, to develop a safe and effective vaccine under the fast track designation.”
The Phase 2 duration is expected to be approximately two years with interim data (primary endpoint) expected mid-2020.
About The Phase 2 Clinical Study VLA15-201
VLA15-201 is the first of two planned, parallel Phase 2 studies. It is a randomized, observerblind, placebo controlled trial conducted at trial sites in the US and Europe. Initially, 120 subjects will receive one of three dosage levels of VLA15, or placebo, followed by a Data Safety Monitoring Board review of safety data. Thereafter, 450 subjects will receive one of two dose levels of VLA15 (180 subjects each), or placebo (90 subjects), in the main study phase.
VLA15 will be tested as alum adjuvanted formulation and will be administered intramuscularly in three injections, given at Days 1, 29 and 57. Subjects will be followed for one year, with the main immunogenicity readout on Day 85 (Primary endpoint). The study is enrolling healthy adults 18 to 65 years of age. Study centers will be located in areas where Lyme disease is endemic; subjects with a cleared past infection with Borrelia burgdorferi, the bacteria that cause Lyme disease, will also be enrolled.
About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia bacteria transmitted to humans by infected Ixodes ticks. It is considered the most common vector borne illness in the Northern Hemisphere. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 300,000 Americans2 are diagnosed with Lyme disease each year with at least a further 200,000 cases in Europe. Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called Erythema migrans or more unspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia or myalgia) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious complications affecting the joints (arthritis), the heart (carditis) or the nervous system. The medical need for vaccination against Lyme disease is steadily increasing as the disease footprint widens.
Valneva’s vaccine candidate, VLA15, is currently the only active vaccine program in clinical development against Lyme disease. The program was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in July 20175 and Valneva reported positive interim Phase 1 results in March 20186. VLA15 showed a favourable safety profile and was immunogenic in all doses and formulations tested with good OspA-specific IgG antibody responses against all OspA serotypes. VLA15 is a multivalent, protein subunit vaccine that targets the outer surface protein A (OspA)
of Borrelia. It is designed for prophylactic, active immunization against Lyme disease aiming for protection against the majority of human pathogenic Borrelia species. VLA15 is designed to confer protection by raising antibodies that prevent Borrelia from migrating from ticks to humans after a bite. The safety profile is expected to be similar to other vaccines using the same technology that have been approved for active immunization in adults and children.
The target population includes individuals at risk above 2 years of age living in endemic areas, people planning to travel to endemic areas to pursue outdoor activities and people at risk who have a history of Lyme disease (as infection with Borrelia does not confer protective immunity against all pathogenic Borrelia species). Vaccination with OspA was already proven to work in the 1990s and VLA15 pre-clinical data showed that the vaccine has the potential to provide protection against the majority of the Borrelia species pathogenic for humans.
About Valneva SE
Valneva is a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has various vaccines in development including a unique vaccine against Lyme disease. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 450 employees. More information is available at www.valneva.com.