Experimental Vaccine for Prevention of Ebola Virus Infection
Status:
Completed
Trial end date:
2009-05-05
Target enrollment:
Participant gender:
Summary
This study will determine if an experimental vaccine to prevent Ebola virus infection is safe
and what side effects, if any, it causes. Ebola virus infection may range from mild to
severe, and may cause breathing problems, severe bleeding, kidney problems and shock that can
lead to death. The vaccine used in this study contains man-made genetic material similar to
one part of the Ebola virus, which is designed to stimulate an immune response to the virus.
The vaccine itself cannot cause Ebola virus infection because it does not contain any Ebola
virus.
Participants are assigned to one of three groups as they enter into the study. Of the first
16 people in the study, 12 receive the lowest study dose of vaccine and 4 receive placebo (an
inactive substance). If this dose is safe, then of the next 16 people who enter the study, 12
receive a higher dose of the vaccine, and the remaining 4 receive placebo. If this dose is
safe, the final 12 people in the last group of 16 receive the highest study dose, and 4
receive placebo. The vaccine is given as a single injection in the arm on the day of
enrollment.
Participants keep a diary for 5 days, recording their temperature, symptoms and any reaction
at the injection site. They call a study nurse the day after vaccination to report how they
feel, and they return to the clinic approximately six times for follow-up evaluations. These
visits may include a check of vital signs, physical examination, blood and urine tests, or
other medical tests if needed.
...
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)