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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
108
4 mg of Ebola DNA plasmid vaccine, VRC-EBODNA023-00-VP, delivered via intramuscular injection on Weeks 0, 4, and 8
4 mg of Marburg DNA plasmid vaccine, VRC-MARDNA025-00-VP, delivered via intramuscular injection on Weeks 0, 4, and 8
4 mg of saline injection delivered at Weeks 0, 4, and 8
Makerere University Walter Reed Project (MUWRP) clinic
Kampala, Uganda
Safety of Ebola vaccine, as seen in local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse experiences
Time frame: Measured at 11 or more visits over 2 years
Safety of Marburg vaccine, as seen in local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious adverse experiences
Time frame: Measured at 11 or more visits over 2 years
Immunogenicity of Ebola vaccine, as seen in ELISA antigen-specific assays for antibodies, intracellular cytokine staining (ICS) assay, and an ELISPOT antigen-specific assay for T cell responses
Time frame: Measured at baseline and Week 12
Immunogenicity of Marburg vaccine, as seen in ELISA antigen-specific assays for antibodies, intracellular cytokine staining (ICS) assay, and an ELISPOT antigen-specific assay for T cell responses
Time frame: Measured at baseline and Week 12
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