An Open-Label Phase II Study to Evaluate Immunogenicity and Safety of a Single IMVAMUNE Booster Vaccination Two Years After the Last IMVAMUNE Vaccination in Former POX-MVA-005 Vaccinees
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ClinicalTrials.gov Identifier: NCT00686582 |
Recruitment Status :
Completed
First Posted : May 30, 2008
Results First Posted : February 18, 2019
Last Update Posted : March 13, 2019
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Tracking Information | |||
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First Submitted Date ICMJE | May 27, 2008 | ||
First Posted Date ICMJE | May 30, 2008 | ||
Results First Submitted Date ICMJE | December 19, 2018 | ||
Results First Posted Date ICMJE | February 18, 2019 | ||
Last Update Posted Date | March 13, 2019 | ||
Study Start Date ICMJE | August 2008 | ||
Actual Primary Completion Date | December 2008 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Individual Peak Booster Rate by ELISA (Percentage of Participants) [ Time Frame: within 4 weeks ] Booster rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA) is defined as the percentage of subjects with an appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or an increase of the antibody titer compared to Baseline titer for initially seropositive subjects. Individual Peak booster rate is based on the maximum post-Baseline antibody titer within 4 weeks (measurements at Weeks 1, 2, and 4). Percentages based on number of subjects with data available.
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Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | An Open-Label Phase II Study to Evaluate Immunogenicity and Safety of a Single IMVAMUNE Booster Vaccination Two Years After the Last IMVAMUNE Vaccination in Former POX-MVA-005 Vaccinees | ||
Official Title ICMJE | An Open-Label Phase II Study to Evaluate Immunogenicity and Safety of a Single IMVAMUNE Booster Vaccination Two Years After the Last IMVAMUNE Vaccination in Former POX-MVA-005 Vaccinees | ||
Brief Summary | The study was preformed to evaluate the persistence of antibodies following vaccination with MVA-BN and to assess the immunological memory response induced by a booster vaccination with MVA-BN in subjects two years after their participation in trial POX-MVA-005 (NCT00316524) in which they had received one or two doses of MVA-BN. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 | ||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Smallpox | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||
* 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 |
304 | ||
Original Enrollment ICMJE | Not Provided | ||
Actual Study Completion Date ICMJE | June 2009 | ||
Actual Primary Completion Date | December 2008 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria: Groups 1 and 2 (first consenting 75 subjects in each group to be vaccinated)
Group 4 (all subjects) and Groups 1 and 2 (subjects N > 75): blood draw only
Exclusion Criteria: Groups 1 and 2 (first consenting 75 subjects in each group to be vaccinated)
Group 4 (all subjects) and Groups 1 and 2 (subjects N > 75): blood draw only
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||
Accepts Healthy Volunteers ICMJE | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Germany | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00686582 | ||
Other Study ID Numbers ICMJE | POX-MVA-023 EudraCT-No.2007-006297-28 DMID 08-0018 |
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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 | Bavarian Nordic | ||
Original Responsible Party | Monika Fluer, Bavarian Nordic | ||
Current Study Sponsor ICMJE | Bavarian Nordic | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Bavarian Nordic | ||
Verification Date | February 2019 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |