NIAID Opens First AIDS Vaccine Trial in Africa

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trials of HIV vaccines.
"Every person enrolled will be fully informed by our medical staff as to
what will be done in the trial and what risks or benefits may result from
their participation," says Dr. Mugerwa. "The ethical standards applied in
this trial are internationally accepted and are the same as those in the
United States."
"Although small in size, this trial is important symbolically as a first
critical step in developing an effective vaccine for Africa," says Dr.
Ellner.
***STUDY DETAILS***
The Phase i trial, known as HIVNET 007, will enroll 40 healthy, HIV-negative
adults between 18 and 40 years old who are at low risk for becoming infected
with HIV. The volunteers will be randomly assigned to one of three groups:
20 individuals will receive the HIV vaccine; 10 individuals will serve as
controls by receiving a similar experimental canarypox vaccine for rabies;
and 10 additional control individuals will receive a placebo that does not
contain any vaccine.
Each person will get four injections over six months. During the study,
neither the study participants nor the health professionals involved will
know which type of injection each volunteer receives. At every clinic
visit, volunteers will be counseled about how to avoid HIV exposure during
the study.
The study will last one year, with one additional year of follow-up to
monitor safety and the durability of the immune responses to the vaccine.
Specifically, they will monitor reactions to the vaccines and look for
immune responses directed against HIV itself (neutralizing antibodies) or
against cells infected with HIV (cytotoxic T lymphocytes, or CTLs). Apart
from this information on the vaccine's safety and potential for protection,
no information on its effectiveness can be obtained from this small trial.
***THE VACCINE***
The ALVAC vCP2O5 vaccine cannot cause HIV infection. First, the vaccine
contains only three HIV genes, which by themselves cannot produce an
infectious virus. Second, these genes are inserted into a weakened version
of the canarypox virus. Canarypox virus serves solely aS the gene carrier,
or vector, to safely express specific HIV proteins known to elicit immune
responses against HiV. Because canarypox virus can not replicate in human
cells, no new canarypox viruses are formed.

***SEARCHING FOR CROSS-REACTIVE IMMUNE RESPONSES***
The genes in the vaccine come from only ciade B viruses, the predominant
subtype of HIV found in the United States and Europe. However, the
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