Date: 2016-12-09
Type of
information: Clinical trial autorization
phase: 1
Announcement: clinical trial authorization
Company: Valneva (France- Austria)
Product: VLA15
Action
mechanism:
- vaccine. Valneva is developing a new hexavalent, protein subunit-based vaccine targeting the Outer Surface Protein A (OspA) of Borrelia. OspA is, one of the most dominant proteins expressed by the bacteria when present in a tick. Pre-clinical data showed that Valneva’s vaccine candidate can provide protection against the majority of Borrelia species pathogenic for humans.
Disease: Lyme borreliosis
Therapeutic
area: Infectious diseases
Country: Belgium, USA
Trial
details:
- The study is assessing the safety, immunogenicity and dose response of VLA15, a new multivalent recombinant OspA vaccine candidate against Lyme borreliosis, in healthy adults aged below 40 years. 180 subjects will be enrolled in 6 treatment groups (different doses; different formulation: with/without adjuvant); vaccinations will be given I.M.(intramuscular) into the deltoid region on Days 0, 28 and 56. Study participants will be followed up until one year after first vaccination. (NCT03010228)
Latest
news:
- • On December 9, 2016, Valneva announced that its vaccine candidate VLA15 against Lyme disease is now progressing into clinical testing following the Investigational New Drug application (IND) clearance from the FDA and the approval of the Clinical Trial Application (CTA) in Europe (Belgium).
- Valneva´s Phase I trial VLA15-101 is being conducted at two sites – one in the U.S. and one in Europe (Belgium) and will enroll 180 subjects, aged 18-40 years. The primary objective of the single-blind, partially randomized, dose escalation study will be to evaluate the product candidate´s safety and tolerability. Immunogenicity, measured by observing IgG antibodies specific against six OspA serotypes, will also be monitored for different dose groups and formulations at different time-points.
Is
general: Yes
