phase 2 study of vla15, a vaccine candidate against lyme borreliosis, in a healthy pediatric and adult study population

Conditions: Lyme Borreliosis

Summary: vla15-221 is a phase 2 study, which will be conducted in two parts: main study phase (part a) and booster phase (part b). the study will compare the safety and immunogenicity of two different primary immunization schedules applying three (month 0-2-6) or two (month 0- 6) vaccinations. within the study, 600 healthy subjects aged 5-65 years will be included. subjects with a history of lyme borreliosis (previous infection with borrelia) as well as borrelia naïve subjects will be enrolled. study duration per subject will be a maximum of 50 months per subject.

vla15-221 is a randomized, observer-blind, placebo controlled, multicenter phase 2 study, which is set up in two parts: main study phase (part a) and booster phase (part b). in part a 600 subjects aged 5-65 years will be enrolled 1:1:1 into three groups: group 1 will be vaccinated with vla15 at month 0-2-6, group 2 will be vaccinated with vla15 at month 0-6 and with placebo at month 2 and group 3 will be vaccinated with placebo at month 0-2-6. in part b all eligible subjects will receive booster injections with vla15 or placebo at month 18, 30 and 42.

Eligibility criteria:
inclusion criteria: * subject is aged 5 to 65 years at the day of screening (visit 0) * subject is of good general health * parent(s)/legal representative(s) and subject understand the study and its procedures, agree to its provisions * for subjects aged 18-65 years: written informed consent prior to any study related procedures * for subjects aged 5-17 years: written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable, prior to any study related procedures. * if subject is of childbearing potential: subject has a negative serum pregnancy test at screening (visit 0) and agrees to employ adequate birth control measures according to following timelines: * main study phase: duration of entire study * booster phase: until 5 months after each booster vaccination (booster 1 until month 23, booster 2 until month 35 and booster 3 until month 47) * subject is willing and able to comply with scheduled visits, treatment plan, and other study procedures * subject is available for the duration of the study and can be contacted by telephone during study participation exclusion criteria: * subject has a chronic illness related to lyme borreliosis (lb), an active symptomatic lb, or received treatment for lb within the last 3 months prior to day 1; * subject received previous vaccination against lb; * subject had a tick bite within 4 weeks prior to day 1; * subject has a medical history of or currently has a clinically relevant disease; * subject has a medical history of or currently has a neuro- inflammatory or autoimmune disease; * subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to day 1; * subject has received an active or passive immunization within 4 weeks prior to day 1; * subject has received any other registered or non-registered medicinal product in another clinical trial within 4 weeks prior to vaccination at day 1; * subject has a known or suspected defect of the immune system or received immuno-suppressive therapy within 4 weeks prior to day 1; * subject has a history of anaphylaxis of unknown cause or severe allergic reactions of unknown cause or has a known hypersensitivity or allergic reactions to one of the components of the vaccine; * subject had any malignancy in the past 5 years; * subject is pregnant, has plans to become pregnant during the course of the study or is lactating at the time of enrollment; * subject has donated or plans to donate blood or blood-derived products 4 weeks prior to day 1; * subject has any condition that may compromise its well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study; * subject is in a dependent relationship with the sponsor/investigator

Keywords: vla15 lyme borreliosis vaccine lyme disease borrelia