Phase 1/2 Lyme Vaccine Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01504347 |
Recruitment Status :
Completed
First Posted : January 5, 2012
Last Update Posted : May 5, 2021
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Tracking Information | ||||
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First Submitted Date ICMJE | December 22, 2011 | |||
First Posted Date ICMJE | January 5, 2012 | |||
Last Update Posted Date | May 5, 2021 | |||
Actual Study Start Date ICMJE | March 1, 2011 | |||
Actual Primary Completion Date | September 13, 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Phase 1/2 Lyme Vaccine Study | |||
Official Title ICMJE | Randomized, Double-Blind, Phase 1/2 Clinical Study to Investigate the Safety and Immunogenicity of a Multivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) in Healthy Subjects Aged 18 to 70 Years | |||
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 adjuvant in seronegative healthy adults aged 18 to 70 years. The outcome shall provide the basis for dose/formulation selection for Section 2 of the study. Section 2: An additional purpose of the study is to evaluate the safety and immunogenicity of the optimal dose(s)/formulation of the mv rOspA LB Vaccine in a larger population of seronegative and seropositive healthy subjects aged 18 to 70 years. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Prophylaxis of Lyme Borreliosis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
1630 | |||
Original Estimated Enrollment ICMJE |
650 | |||
Actual Study Completion Date ICMJE | February 28, 2014 | |||
Actual Primary Completion Date | September 13, 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Main Inclusion Criteria:
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 Criteria:
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 |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01504347 | |||
Other Study ID Numbers ICMJE | 730901 2010-023384-18 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Takeda ( Baxalta now part of Shire ) | |||
Original Responsible Party | Baxter Healthcare Corporation | |||
Current Study Sponsor ICMJE | Baxalta now part of Shire | |||
Original Study Sponsor ICMJE | Baxter Healthcare Corporation | |||
Collaborators ICMJE | Baxter Innovations GmbH | |||
Investigators ICMJE |
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PRS Account | Takeda | |||
Verification Date | May 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |