This study will evaluate whether an experimental vaccine intended to prevent HIV infection is
safe and whether it causes any side effects. It will also examine whether the vaccine, called
VRC-HIVDNA016-00-VP, causes an immune response, and will monitor participants for the social
impact of being in an HIV vaccine study. VRC-HIVDNA016-00-VP contains synthetic DNA that
codes for parts of four HIV proteins. It also contains a "promoter" piece of DNA that is
needed to start protein production. The promoter DNA is also synthetic and is like the
promoter in another virus called cytomegalovirus (CMV). The vaccine contains no live HIV
virus or CMV and cannot cause either of these illnesses.
Healthy volunteers between 18 and 44 years old who are HIV-negative may be eligible for this
32-week study. Candidates are screened with a medical history, physical examination, and
blood and urine tests.
Participants receive three injections of the experimental vaccine approximately 28 days
apart. The injections are given with a system called the Biojector 2000 that delivers the
vaccine through the skin into the muscle without the use of a needle. Subjects are observed
for side effects for at least 30 minutes after each vaccination and are required to telephone
the clinic staff 1 to 2 days after the injection to report how they are doing. In addition,
they are given a diary card to take home, on which they record their temperature and any
symptoms daily for five days.
Participants return to the clinic two weeks after each injection. They return the completed
diary card and are checked for any health changes or problems since the last visit. They are
asked how they are feeling and what medications, if any, they have taken. Blood and urine
samples are collected. Some subjects may be asked to have laboratory tests between regular
visits if needed to evaluate a change in health. Participants are also asked about any social
effects they may have experienced as a result of their participation in the study.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)