A total of 819 subjects have been recruited for Phase 2 development in two ongoing studies. The results of these studies, comprising immunogenicity and safety data, will support the dose and vaccination schedule to be used in Phase 3.
Study VLA15-201 includes 573 subjects across nine sites in Europe and the U.S. Study VLA15-202 includes 246 subjects across five sites in the U.S. In both studies, dosage levels of 135µg and 180µg of VLA15 are used and administered either at Day 1, Month 1 and Month 2 (VLA15-201) or at Day 1, Month 2 and Month 6 (VLA15-202).
Wolfgang Bender, MD, PhD, Chief Medical Officer of Valneva, commented, “We are extremely pleased that all Phase 2 subjects have been recruited as planned and on target. We are making great progress in developing our Lyme disease vaccine candidate with the aim of addressing this significant unmet medical need. I would also like to thank our internal teams as well as our CROs and study sites for their dedication and commitment to achieve the subject recruitment on time. We are looking forward to our initial Phase 2 results in 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, observer-blind, placebo controlled trial conducted at trial sites in the U.S. and Europe.
In the run-in Phase, 120 subjects received one of three dosage levels of VLA15, or placebo. Following review of safety data by an independent Data Safety Monitoring Board, 453 subjects in the main study phase now receive one of two selected dose levels of VLA15, or placebo.
VLA15 is tested as an alum adjuvanted formulation and administered intramuscularly in three injections, given one month apart at Days 1, 29 and 57. Subjects will be followed for one year, with the main immunogenicity readout one month after the third immunization on Day 85 (primary endpoint). The study has enrolled healthy adults 18 to 65 years of age. Study centers are located in areas where Lyme disease is endemic; subjects with a cleared past infection with Borrelia burgdorferi, the bacteria that cause Lyme disease, were also enrolled.
About the Phase 2 Clinical Study VLA15-202
VLA15-202 is the second of two planned Phase 2 studies. It is a randomized, observer-blind, placebo controlled trial conducted at trial sites in the US.
246 subjects receive one of two dosage levels of VLA15 or placebo.
VLA15 is tested as alum adjuvanted formulations with 135μg and 180μg dosage levels and administered intramuscularly in three injections, given at Days 1, 57 and 180. Subjects will be followed for 18 months, with the main immunogenicity readout on Day 208 (primary endpoint). The study has enrolled healthy adults 18 to 65 years of age. Study centers are located in areas where Lyme disease is endemic; subjects with a cleared past infection with Borrelia burgdorferi, the bacteria that cause Lyme disease, were also 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 Americans 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 2017 .
Valneva reported final Phase 1 data demonstrating VLA15’s favorable safety profile and immunogenicity in all doses and formulations tested, with good OspA-specific IgG antibody responses against all OspA serotypes. In addition, VLA15 elicited an excellent anamnestic response following a booster vaccination in a time window of 12 to 15 months after initial primary immunization. As part of the ongoing Phase 2, two higher, alum-adjuvanted formulations have been selected for further development.
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 in Europe and the US. 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 lipidated protein based vaccines that are 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 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 480 employees. More information is available at www.valneva.com.
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 Stanek et al. 2012, The Lancet 379:461–473
 As estimated by the CDC, https://www.cdc.gov/lyme/stats/humancases.html.
 Estimated from available national data. Number largely underestimated based on WHO Europe Lyme Report as case reporting is highly inconsistent in Europe and many LB infections go undiagnosed; ECDC tick-borne-diseases-meeting-report
 New Scientist, Lyme disease is set to explode and we still don’t have a vaccine; March 29, 2017