An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)

Key Inclusion Criteria:

• Participants who reside in areas with endemic Lyme disease and who lead lifestylesthat put them at increased risk for Lyme disease. For example, this could include,but not be limited to:

• Individuals who work in B burgdorferi-infected/tick-infested areas, especially thosewith occupations that may be associated with higher risk of exposure, such aslandscaping, forestry, and wildlife and parks management.

• Individuals who pursue recreational activities such as hiking, camping, fishing,hunting, jogging, or gardening in such areas.

• Individuals who live on land plots with tree lines and come into contact with thesetrees regularly.

• Individuals who have dogs that regularly are outdoors and frequently return withattached ticks.

• Individuals who participate in activities in areas with tall grass, smaller woodedareas beside forests, open fields, lakesides, and riversides.

Key Exclusion Criteria:

• Any female participants that are pregnant (or have a positive urine pregnancy test)or are breastfeeding.

• Any diagnosis of Lyme disease within the past 3 months.

• Any history of Lyme carditis, neuroborreliosis, or arthritis, or other disseminatedLyme disease regardless of when diagnosed.

• Known tick bite within the past 4 weeks.

• Newly developed or unstable underlying conditions that may interfere with theassessment of Lyme disease, including but not limited to chronicarthralgia/arthritis, second/third-degree AV heart block, chronic pain syndromes,and chronic skin conditions that reduce the ability to detect cutaneousmanifestations of Lyme disease.

• Any unstable autoimmune condition with a manifestation (eg, arthritic andneurologic) that may interfere with the assessment of Lyme disease.

• Chronic systemic doxycycline or minocycline or other tetracycline class drug use foracne or any other chronic suppressive antibiotics used to treat other conditions.