This study will determine the safety and side effects of an experimental adenoviral vector
vaccine given to patients who previously received a different HIV vaccine
(VRC-HIVDNA016-00-VP) in a prior NIAID study. The study will also monitor participants for
the social impact of being in an HIV vaccine study (e.g., problems with insurance, health
care, friends, family, employment, housing, and so forth). The study vaccine is made using an
adenovirus (a common virus that causes upper respiratory infections, such as the common cold,
eye infection, urine infection or diarrhea) that has been modified to contain DNA that codes
for three HIV proteins. The modified virus cannot reproduce in the body and cannot cause HIV
disease or adenoviral infections.
Healthy volunteers who previously received three injections of the VRC-HIVDNA016-00-VP under
the NIAID study VRC 007 (protocol 04-I-0254) may be eligible for this study.
Participants receive one injection of the adenoviral vector vaccine. It is given the day they
enroll in the study, as a single injection in an upper arm muscle. Also on that day they have
a brief physical examination, medical history, blood and urine tests, pregnancy test for
women, and counseling, as needed, about HIV and pregnancy avoidance. Subjects are observed
for side effects for at least 30 minutes after the vaccination and are required to telephone
the clinic staff 1 to 2 days after the injection for follow-up. In addition, they are given a
diary card to take home, on which they record their temperature and any symptoms daily for 5
days.
Subjects return to the clinic for 5 follow-up visits at weeks 2, 4, 6, 12 and 24 after the
injection. At each visit they are checked for health changes or problems since the last
visit, asked how they are feeling and what medications they are taking. They have blood drawn
at every visit and urine samples collected at most visits. They are tested for HIV three or
more times and are questioned about their sexual behavior and drug use. They also complete a
"social impact" questionnaire at the last visit.
Subjects are asked to undergo apheresis at the week 4 visit. This procedure allows collection
of a larger number of white blood cells than can be obtained by a simple blood draw. The
white cells are studied to see how the immune system responds to the study vaccine. For
apheresis, blood is collected through a needle in an arm vein and spun in a machine that
separates the components. The white blood cells are extracted and the rest of the blood is
returned to the body through the same needle. Subjects who do not undergo apheresis have
about 1/3 cup of blood sample drawn using a needle.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)