Phase 1/2 Lyme Vaccine Study

Exclusion Criteria

• •Subject has a physician-diagnosed chronic illness related to Lyme borreliosis (LB) or active LB
• •Subject has been treated for LB with antibiotics within 3 months of study entry
• •Subject had a tick bite within 3 weeks prior to screening or first vaccination
• •Subject has a history or active infection with Babesia microti (babesiosis) or Anaplasma phagocytophilum (ehrlichiosis)
• •Subject currently has or has a history of significant cardiovascular, respiratory (including asthma), metabolic, neurological, hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder
• •Subject has clinically significant abnormal laboratory values at screening
• •Subject currently has or has a history of immunodeficiency
• •Subject tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
• •Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that could be expected to influence immune response.
• •Subject has a history of anaphylaxis or severe allergic reactions
• •Subject has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study
• •Subject is pregnant or lactating at the time of study enrollment
• •Additional exclusion criterion for subjects in Section 1 and seronegative subjects in Section 2:
• •\- Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry