This study will test the safety of an experimental vaccine intended to prevent West Nile
virus (WNV) infection and determine if it causes side effects. WNV symptoms may vary from
fever and headache, to a polio-like syndrome with paralysis. Infection rarely results in
death. The vaccine used in this study contains DNA that instructs the body to produce a small
amount of a protein found in WNV. If the body creates resistance or immunity to these
proteins, then the vaccine may protect against WNV. Study participants cannot get WNV from
the vaccine.
Healthy volunteers between 18 years and 50 years of age may be eligible for this study.
Candidates are screened with a medical history, physical examination, and blood and urine
tests, including a pregnancy test for women who can become pregnant. Patients undergo the
following tests and procedures:
- Vaccine injections: Vaccines are given as injections in the upper arm, using a
needleless system called the Biojector 2000. The first injection is on study day 0, the
second on day 28 (+/-) 7 days, and the third on day 56 (+/-) 7 days. There must be at
least 21 days between injections. The pregnancy test for women of childbearing potential
is repeated the day of each vaccine injection.
- Diary card: Participants are given a 5-day diary card after each injection to record
their temperature and any symptoms and side effects they may experience for up to 5 days
after the injection. The diary cards are returned to the clinic at visits scheduled 2
weeks after each injection. Side effects and symptoms also must be reported immediately
to a study nurse or doctor, and a clinic visit may be required for an examination.
- Clinic visits: At day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32, participants have a
medical history, physical examination (if needed) and blood tests. Vital signs and
weight are also recorded. Lymph nodes are examined at day 0 and weeks 2, 4, 6, 8, 10 and
12, and urine samples are collected at day 0 and weeks 2, 4, 6, 8 and 10.
Some of the blood drawn during this study is used for genetic tests to see if different types
of immune response to a vaccine are related to genetic differences in people.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)