This study will test the safety of an experimental vaccine developed to protect against Ebola
virus infection and to determine if the vaccine induces an immune response to the virus. The
Ebola virus causes a disease called Ebola hemorrhagic fever. Symptoms begin with fever and
muscle aches and progress to breathing problems, severe bleeding, kidney problems, and shock.
The infection may be mild, but it can also lead to death. The vaccine used in this study is
made from small parts of Ebola genetic material. It cannot cause Ebola hemorrhagic fever to
develop in those who receive it.
Healthy volunteers 18 to 44 years of age may be eligible for this study. Candidates will be
screened with a medical history, physical examination, and laboratory tests, and complete an
"assessment of understanding" questionnaire to show that they understand the study.
Depending on their order of entry into the study, participants are assigned to receive one of
three vaccine doses or placebo. The first group receives the lowest dose (2 milligram) of
vaccine or placebo. If this dose is safe, then the second group receives 4 mg, and if this
dose is safe, the third group receives 8 mg. Injections are given in a muscle in the upper
arm. Participants receive three injections, each 4 weeks apart (on study days 0, 28, and 56).
Participants record their temperature and symptoms in a diary card for 7 days following each
injection. They return to the clinic 2 to 3 days after each injection and then 2 weeks after
each injection until study week 10. Additional follow-up visits are then scheduled at weeks
12, 24, 38, and 52. At each visit, participants provide a blood and urine sample for testing
and have their vital signs, and lymph nodes checked, their weight measured, and their
symptoms reviewed. Additional laboratory tests may be requested between visits.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)