NCT00997607

Evaluating an Ebola and a Marburg Vaccine in Uganda

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ebola Virus Disease
• Marburg Virus Disease

Interventions

Type	Name	Description
BIOLOGICAL	Ebola vaccine	4 mg of Ebola DNA plasmid vaccine, VRC-EBODNA023-00-VP, delivered via intramuscular injection on Weeks 0, 4, and 8
BIOLOGICAL	Marburg vaccine	4 mg of Marburg DNA plasmid vaccine, VRC-MARDNA025-00-VP, delivered via intramuscular injection on Weeks 0, 4, and 8
OTHER	Placebo injection	4 mg of saline injection delivered at Weeks 0, 4, and 8

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2009-10-19
• Last updated: 2013-01-28

Locations

1 site across 1 country: Uganda