Status:
COMPLETED
Phase 1/2 Lyme Vaccine Study
Lead Sponsor:
Baxalta now part of Shire
Collaborating Sponsors:
Baxter Innovations GmbH
Conditions:
Prophylaxis of Lyme Borreliosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Section 1: The purpose of the study is to obtain safety and immunogenicity data of different dose levels of a multivalent recombinant OspA Lyme Borreliosis (mv rOspA LB) Vaccine with and without adju...
Eligibility Criteria
Inclusion
- Main
- Subject is 18 to 70 years old at the time of screening
- Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry
- Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination
- If female of childbearing potential, presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
- Additional inclusion criterion for seropositive subjects in Section 2 only:
- \- Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry
- Main
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2014
Estimated Enrollment :
1630 Patients enrolled
Trial Details
Trial ID
NCT01504347
Start Date
March 1 2011
End Date
February 28 2014
Last Update
May 5 2021
Active Locations (8)
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1
Medical University Vienna, Dept. of Clinical Pharmacology
Vienna, Austria, 1090
2
Zentrum für Reisemedizin (Center for Travel Medicine)
Vienna, Austria, 1090
3
Berliner Centrum für Reise- und Tropenmedizin GmbH (BCRT)
Berlin, Germany, 10117
4
GWT-TUD GmbH
Dresden, Germany, 01307