This study will test the safety of an experimental vaccine against HIV and examine whether it
induces an immune response to HIV. A vaccine is a substance given to try to create resistance
or immunity to a disease or infection. The vaccine in this study is made from DNA (genetic
material) of four HIV proteins called gag, pol, Nef, and Env. Injected into a human, the
viral DNA instructs the body to make small amounts of some HIV proteins. This study will see
if the body then creates an immune response to these proteins. Study participants cannot
catch HIV or AIDS from the DNA vaccine or any proteins made from it.
Healthy normal volunteers between 18 and 60 years of age may be eligible for this study.
Candidates will provide a medical history, including information on sexual behaviors and drug
use. They will have a physical examination and blood and urine tests. Women will also have a
pregnancy test. Women enrolled in the study must either be infertile (e.g., due to menopause
or hysterectomy) or must agree either to abstain from heterosexual sex or to practice birth
control for at least 21 days before beginning the study and throughout its duration.
Participants will be randomly assigned to receive either the experimental vaccine or a
placebo (a control substance made up of an inactive salt solution) and will be divided into
three groups, based on their entry into the study. Of the first seven people enrolled (Group
1), five will receive a 2-mg dose of vaccine and two will receive placebo. If the vaccine is
safe at this dose, then in Group 2, five people will receive a 4-mg dose of vaccine and two
will receive placebo. If this dose is safe, then in Group 3, thirty people will receive an
8-mg dose of vaccine and six will receive placebo.
All participants will receive three injections in an upper arm muscle-one injection a month
for three months-with a needle-less device called a Biojector 2000® (Registered Trademark).
At the time of each injection, participants will be observed for at least 1 hour after
immunization. At home, they will record their temperature and any symptoms they may
experience, including any effects at the injection site, for at least 2 days, or as long as
the symptoms remain. If symptoms occur, participants will report them immediately to the
clinic staff and, if necessary, come to the clinic for an examination.
Participants will have about 10 clinic visits during the study. Most visits will last about 2
hours; those on vaccination days will last about 4 hours. At each visit, participants will be
checked for health changes or problems and will be asked about medications they are taking.
Blood will be drawn for immune system testing. Additional laboratory tests may be requested
between visits. Participants will be tested several times for HIV, will be questioned about
their sexual behavior and drug use, and about social effects they may have experienced from
their participation in the study.
Some of the blood drawn for this study will be used to test for HLA type-a genetic test of
immune system markers. For research, HLA testing is sometimes used to try to identify factors
associated with the progression of HIV disease or related conditions.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)