Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis

Inclusion Criteria - Main Study Phase:

• Subject is aged 18 to 65 years at the day of screening
• Subject is of good general health, including subjects with pharmacologically controlled chronic conditions;
• Subject has an understanding of the study and its procedures, agrees to its provisions,and gives written informed consent prior to any study-related procedures;
• If subject is of childbearing potential:
• Subject has a negative serum pregnancy test at screening;
• Subject agrees to employ adequate birth control measures for the duration of the study.

Inclusion Criteria - Booster Phase:

• Randomization into higher dose group in the Main Study Phase
• No relevant protocol deviation in the Main Study Phase, i.e., included in the Per-Protocol population for the Day 208 interim analysis of the Main Study;
• Subject is of good general health, including subjects with pharmacologically controlled chronic conditions;
• Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures;
• If subject is of childbearing potential:
• Subject has a negative Urine pregnancy test before booster vaccination;
• Subject agrees to employ adequate birth control measures for the duration of the study

Exclusion Criteria - Main Study Phase:

• Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB as suspected or diagnosed by a physician, or received treatment for LB within the last 3 months prior to screening;
• Subject received previous vaccination against LB.;
• Subject had a tick bite within 4 weeks prior to vaccination visit;
• Subject has a medical history of or currently has a clinically relevant disease (e.g. cardiovascular, respiratory, neurologic, psychiatric conditions) which poses a risk for participation in the study, based on investigators judgement, such as individuals with poorly controlled or unstable disease, ongoing suspected or active inflammation, or poor compliance with pharmacologic treatment. Subjects with pharmacologically controlled conditions like osteoarthritis, depression, or asthma are eligible;
• Subject has a medical history of or currently has a neuroinflammatory or autoimmune disease, including Guillain Barré Syndrome;
• Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the three weeks prior to each study vaccination, contraindicating I.M. vaccination as judged by the investigator;
• Subject has received an active or passive immunization within 28 days before or after any vaccination; except for influenza (seasonal or pandemic) vaccines which may be administered outside a 7-days interval before or after any trial vaccination;
• Subject has received any other non-registered medicinal product in another clinical Trial within 28 days prior to VLA15 vaccination and throughout the entire study period or has received a registered medicinal product in another clinical Trial within 28 days prior to VLA15 vaccination and up to Day 208;
• Subject has a known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired immunodeficiency, including infection with human immunodeficiency virus (HIV), Status post organ transplantation or immuno-suppressive therapy within 30 days prior to first vaccination. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent >=0.05 mg/kg/day. Topical and inhaled steroids are allowed;
• Subject has a history of anaphylaxis or severe allergic reactions or a known hypersensitivity or allergic reactions to one of the components of the vaccine; Subject had any malignancy in the past 5 years. If treatment for cancer was successfully completed more than 5 years ago and the malignancy is considered to be cured, the subject may be enrolled;
• Subject had acute febrile infections within 10 day