Phase I Study of HIV Adenoviral Vector Vaccine in Healthy Subjects Using Needle or Biojector Injection
Status:
Completed
Trial end date:
2014-05-20
Target enrollment:
Participant gender:
Summary
This study will compare the immune response and side effects of an experimental HIV vaccine
given by two different methods of administration by needle injection or by use of a
needle-free device called the Biojector 2000 (Registered Trademark). The vaccine, called
VRC-HIVADV014-00-VP, or rAd5, is made using an adenovirus that has been modified to contain
DNA that codes for three HIV proteins. It cannot cause HIV or adenoviral infections.
Healthy volunteers who are not infected with the HIV virus may be eligible for this study.
Subjects are recruited for two study groups: Group 1 comprises volunteers who are 18 to 50
years old and have never received an HIV vaccine and Group 2 comprises volunteers who are 18
to 55 years old and participated in a prior study in which they received at least one
injection of the study rAd5 vaccine.
Subjects in both groups are randomly assigned to receive the vaccine by needle or Biojector
2000 (Registered Trademark) into a muscle in the upper arm. They call a study nurse 2 days
after the injection, record their temperature and symptoms on a diary card at home for 5 days
after the injection for later review, and visit the clinic two weeks after the injection for
a checkup.
The injection is given on the day of enrollment. Additional visits are scheduled at weeks 2,
4, 12 and 24, when subjects are checked for health changes or problems, their use of
medications and how they are feeling. Blood samples are collected at all clinic visits.
Subjects are tested for HIV at the beginning and end of the study, are asked about their
sexual behavior and drug use, and are counseled about HIV risk reduction. Women are tested
for pregnancy at the beginning and end of the study.
Participants in Group 2 may undergo apheresis at the 4-week visit. This procedure is done to
collect white blood cells for tests to examine the immune response to the vaccine. Blood is
collected through a needle in the vein of one arm and directed through a machine that
separates the cell components. The white cells are removed and the rest of the blood is
returned through the same needle.
Subjects are asked about any social effects they may have experienced from participating in
the study. These effects are monitored to make sure participants receive any needed
assistance and to learn ways to prevent these problems in the future.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)