Phase 1 Safety Study of Two Experimental HIV Vaccines
Status:
Completed
Trial end date:
2014-05-05
Target enrollment:
Participant gender:
Summary
This study will test whether two experimental HIV vaccines are safe and whether they cause
any side effects in healthy adults. It will examine the body s immune response to the
vaccines and monitor the social impact, if any, of being in an HIV vaccine study. The
experimental vaccines in this study are the VRC-HIVADV027-00-VP (also called the rAd35-EnvA
vaccine) and VRC-HIVADV038-00-VP (also called the rAd5-EnvA vaccine). The vaccines are made
using an adenovirus (virus that normally causes respiratory infections and colds) that has
been modified to contain DNA that codes for HIV proteins. The vaccines cannot cause HIV or
adenoviral infections.
Healthy normal volunteers between 18 and 50 years of age may be eligible for this 2-part
study. Part 1 includes 15 people. Part 2 includes 20 people.
Part 1 participants receive only the rAd35-EnvA vaccine. The first five people enrolled
receive the lowest study dose of the vaccine. If this dose is safe, then the next five people
enrolled receive a higher dose. If this dose is safe, then the last 5 people enrolled receive
the highest study dose. Subjects in Part I have about five clinic visits over 24 weeks.
Part II of the study starts after all injections in Part 1 are given. Subjects in Part 2 are
randomly assigned to one of two vaccination schedules. One group receives the rAd35-EnvA
vaccine first, followed 12 weeks later with the rAd5-EnvA vaccine. The other group receives
the vaccines in reverse order; that is, first the rAd5-EnvA vaccine, followed 12 weeks later
with the rAd35-EnvA vaccine. In this schedule, the first vaccination primes the immune system
and then the immune response is boosted 12 weeks later with a different vaccine. Everyone in
study Part 2 receives the rAd35-EnvA vaccine at the middle dose tested in Part 1. Subjects in
Part 2 have about eight clinic visits over 36 weeks.
All vaccinations are given as injections in the upper arm. At each clinic visit, participants
are checked for health changes or problems. They are asked how they are feeling and if they
have taken any medications. Urine samples are collected and blood is drawn at some visits.
They are tested for HIV several times and asked questions about their sexual behavior and
drug use. Throughout the study, participants are counseled on HIV risk reduction. Subjects
are asked about any social effects they may have experienced from their participation in this
study.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)