Ebola Virus Disease Clinical Trial
Official title:
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
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