Evaluating an Ebola and a Marburg Vaccine in Uganda
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ClinicalTrials.gov Identifier: NCT00997607 |
Recruitment Status :
Completed
First Posted : October 19, 2009
Last Update Posted : January 28, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | October 16, 2009 | |||
First Posted Date ICMJE | October 19, 2009 | |||
Last Update Posted Date | January 28, 2013 | |||
Study Start Date ICMJE | February 2010 | |||
Actual Primary Completion Date | April 2012 (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 | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Evaluating an Ebola and a Marburg Vaccine in Uganda | |||
Official Title ICMJE | A Phase IB Study to Evaluate the Safety and Immunogenicity of an Ebola DNA Plasmid Vaccine, VRC-EBODNA023-00-VP, and a Marburg DNA Plasmid Vaccine, VRC-MARDNA025-00-VP, in Healthy Adults in Kampala, Uganda | |||
Brief Summary | This study will test two new vaccines, one for Ebola and one for Marburg virus, to see if they are safe, if they have side effects, and if they create an immune response in people who receive them. | |||
Detailed Description | The Ebola and Marburg viruses are both filoviruses known to induce hemorrhagic fever-a set of symptoms characterized by sudden onset, aching, fever, and bleeding in the internal organs. Both filoviruses are associated with high mortality rates, and the Centers for Disease Control (CDC) lists them as Category A bioterrorism agents because of their potential for a major public health impact. Vaccines for both viruses are under development using a prime-boost strategy that involves multiple injections over a period of time to confer long-lasting immunity. Preliminary research supports the vaccines' safety. This study will test these experimental vaccines for the Ebola and Marburg viruses, first administered separately and then together, to ensure they are safe and do not have side effects. Participation in this study will entail 11 study visits over 2 years. The study will have two parts, to be completed sequentially, and three groups. In part one, participants will be randomly assigned to the first group, which will receive the experimental Ebola DNA vaccine, or the second group, which will receive the experimental Marburg DNA vaccine. In part two, the third group will receive both the Ebola and the Marburg vaccines, one shot in each arm. One fifth of the participants in each group will be controls and receive placebo injections. All vaccines and placebos will be delivered via an intramuscular injection at three time points: at study entry, after 4 weeks, and after 8 weeks. Participants will complete study assessments at 12 points in time: at baseline and at Weeks 2, 4, 6, 8, 10, 12, 24, 32, 52, 78, and 104. At each assessment, changes in health and medications will be recorded and blood will be drawn. Participants will also complete a diary card daily for 5 days after receiving each injection. In it, they will record their temperature and any skin changes at the injection site. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Care Provider) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Kibuuka H, Berkowitz NM, Millard M, Enama ME, Tindikahwa A, Sekiziyivu AB, Costner P, Sitar S, Glover D, Hu Z, Joshi G, Stanley D, Kunchai M, Eller LA, Bailer RT, Koup RA, Nabel GJ, Mascola JR, Sullivan NJ, Graham BS, Roederer M, Michael NL, Robb ML, Ledgerwood JE; RV 247 Study Team. Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial. Lancet. 2015 Apr 18;385(9977):1545-54. doi: 10.1016/S0140-6736(14)62385-0. Epub 2014 Dec 23. | |||
* 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 |
108 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | April 2012 | |||
Actual Primary Completion Date | April 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Uganda | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00997607 | |||
Other Study ID Numbers ICMJE | RV 247 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | National Institute of Allergy and Infectious Diseases (NIAID) | |||
Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Institute of Allergy and Infectious Diseases (NIAID) | |||
Verification Date | January 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |