AIDS Vaccine Developed at Emory University and the National Institutes
of Health Moves to Clinical Trials
A vaccine aimed against AIDS, developed at the Yerkes National Primate
Research Center of Emory University, the Emory Vaccine Center, and the
Laboratory of Viral Diseases at the National Institute of Allergy and
Infectious Diseases (NIAID) of the National Institutes of Health (NIH),
will begin a Phase I clinical trial this week.
A total of 30 human volunteers
will be enrolled at the University of Alabama at Birmingham, the University
of Washington in Seattle, and the San Francisco Department of Public
Health. The trial is funded by NIAID and is conducted by the HIV Vaccine
Trials Network, located at the Fred Hutchinson Cancer Research Center
in Seattle, Wash.
Developed by virologists
Harriet L. Robinson, PhD, James M. Smith, PhD, Bernard Moss, MD, PhD,
and Linda Wyatt, PhD, the vaccine strategy employs two different components:
two inoculations of a DNA vaccine that primes the immune system to recognize
HIV; and a subsequent booster vaccine based on a recombinant poxvirus.
Neither component incorporates the actual virus; instead, the vaccine
produces the three major proteins expressed by HIV. In essence, the
vaccine induces the immune system to respond to the distinguishing features
of HIV so the system will respond to the actual virus should it appear.
This first clinical trial,
which will last one year, will focus on assessing the safety of the
DNA primer vaccine among HIV-negative volunteers, who will be randomly
assigned to receive one of the following: high-dose vaccine, low-dose
vaccine, or placebo. A second, separate clinical trial will focus on
the safety of the booster vaccine.
"We will have a third Phase
I trial to test the combined regimen of the DNA and booster portions
of the vaccine strategy," said Dr. Robinson, who is chief of the Yerkes
Division of Microbiology and Immunology and a faculty member of the
Emory Vaccine Center.
As Robinson and her colleagues
reported in Science in 2001, in a study involving 24 rhesus macaque
monkeys, the prime-boost vaccine strategy successfully contained infection
and prevented progression to AIDS. According to a subsequent Yerkes
study reported in October 2002 in the Journal of Virology, levels of
viral RNA and DNA in the monkeys have declined to the nearly undetectable
levels characteristic of a small subset of HIV-infected people, termed
long-term non-progressors, who are infected with HIV but do not develop
"It is important to remember
that this clinical trial represents the culmination of years of work
in basic science and preclinical studies involving animal models that
have greatly expanded our knowledge of immunology," said Vaccine Center
Director Rafi Ahmed, PhD. "Every new AIDS vaccine candidate that enters
human studies brings us closer to understanding HIV and the human immune
system ≠ and to ending the worldwide AIDS pandemic."
The experimental vaccine
is licensed from Emory by GeoVax, Inc., a company founded by Emory University
and the Emory Vaccine Center to manufacture the vaccine.
The Yerkes National Primate
Research Center of Emory University is one of eight National Primate
Research Centers funded by the National Institutes of Health. The Yerkes
Center is a multidisciplinary research institute recognized as a leader
in biomedical and behavioral studies with non-human primates. Yerkes
scientists are on the forefront of developing vaccines for AIDS and
malaria, and treatments for cocaine addiction, Parkinsonís disease and
cardiovascular disease. Other research programs include cognitive development
and decline, childhood visual defects, organ transplant rejection and
social behaviors of primates. Leading researchers located worldwide
seek to collaborate with Yerkes scientists.
The mission of the Emory
Vaccine Center is to create new technologies for the prevention of emerging
infectious diseases, by conducting basic and translational research
and clinical trials. The Vaccine Center was established in 1996 with
support from Emory University and the Georgia Research Alliance.
GeoVax, Inc. is developing
products related to the research described above. Under an agreement
between GeoVax, Inc. and Emory University, the inventors are entitled
to a share of sales royalty received by Emory University from GeoVax.
Under that agreement, Emory University has received GeoVax equity interests.
Dr. Robinson is also Chairman of the Scientific Advisory Board and a
minor equity holder in GeoVax. The terms of this arrangement have been
reviewed and approved by the University in accordance with its conflict
of interest policies.