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New Clinical Trial Begins for HIV/AIDS Vaccine Developed at Emory, GeoVax, NIH and CDC

April 15, 2006

Study reveals how a highly successful vaccine triggers robust immune responses

Media Contacts

Emily Rios, 404-727-7732, erios@emory.edu; Holly Korschun, 404-727-3990, hkorsch@emory.edu; Don Hildebrand, 404-727-0971, dhildebrand@geovax.com

ATLANTA —A new human clinical trial will begin this month at several sites around the country testing both components of an HIV/AIDS vaccine developed by a team of researchers at the Yerkes National Primate Research Center of Emory University, GeoVax, Inc., and the Emory Vaccine Center, along with colleagues at the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC).

The vaccine uses a two-part DNA prime-boost strategy developed by a scientific team led by Harriet Robinson, PhD, chief of microbiology and immunology at the Yerkes Research Center, a faculty member of the Emory Vaccine Center, and chief of the GeoVax, Inc. Scientific Advisory Board.

The vaccine includes two inoculations of a DNA vaccine that primes the immune system to recognize HIV and two doses of subsequent booster vaccine based on a recombinant MVA poxvirus. The vaccine produces the three major proteins expressed by HIV and is expected to induce the immune system to respond to these distinguishing features of HIV should the actual virus appear. Neither component of the vaccine incorporates the complete intact HIV virus.

As reported in Nature Medicine in 1999 and in Science in 2001, a prototype of this vaccine was successful in containing a challenge virus and preventing progression to AIDS in nonhuman primates.

The vaccine technology was licensed to GeoVax, Inc., a company founded by Dr. Robinson, GeoVax President/CEO Don Hildebrand, Emory University and the Emory Vaccine Center to further develop, manufacture, test and evaluate the vaccine.

In 2003, a prototype DNA vaccine was tested in a group of HIV-negative volunteers to evaluate safety. This Phase I human trial was conducted through the HIV Vaccine Trials Network (HVTN). Based on these successful studies, a new GeoVax Investigational New Drug application recently received approval by the U.S. Food and Drug Administration to proceed with additional clinical trials to test the two components of the vaccine in a prime/boost protocol.

Beginning this month, human clinical trials will evaluate the DNA and MVA components of the vaccine in HIV-negative volunteers at several U.S. sites in the HI Vaccine Trials Network, including the University of Alabama at Birmingham, Saint Louis University, the University of Maryland and Vanderbilt University. The HVTN is funded and supported by the National Institute of Allergy and Infectious Disease (NIAID) of the NIH.

This trial will have two phases. The first phase will be a dose escalation to evaluate safety and immune responses. Initially, low doses of the two vaccine components will be given to 12 volunteers. If the vaccine proves safe, the vaccine will then be tested at high dose in 36 volunteers. If the vaccine proves safe and shows good immunogenicity in the dose/escalation studies, a second phase of clinical testing will be initiated. In this phase, 72 volunteers will be used to conduct the initial studies on optimizing the dosing schedule.

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 Research Center is a recognized leader for its biomedical and behavioral studies with nonhuman primates, which provide a critical link between research with small laboratory animals and the clinical trials performed in humans. Yerkes researchers are on the forefront of developing vaccines for AIDS and malaria, and treatments for cocaine addiction and Parkinson's Disease. Yerkes researchers also are leading programs to better understand the aging process, pioneer organ transplant procedures and provide safer drugs to organ transplant recipients, determine the behavioral effects of hormone replacement therapy, prevent early onset vision disorders and shed light on human behavioral evolution.

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 a biotechnology company developing human vaccines for diseases caused by HIV-1 and other infectious agents. Present goals include developing AIDS vaccines for global markets, manufacturing and testing these vaccines under GMP/GLP conditions (FDA guidelines), conducting human trials for vaccine safety and effectiveness and obtaining regulatory approval of these vaccines in the USA and international markets. GeoVax has an exclusive contractual right to this Emory AIDS vaccine technology in return for royalties and an equity interest in GeoVax. 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.


The Robert W. Woodruff Health Sciences Center of Emory University is an academic health science and service center focused on missions of teaching, research, health care and public service. Its components include the Emory University School of Medicine, Nell Hodgson Woodruff School of Nursing, and Rollins School of Public Health; Yerkes National Primate Research Center; Winship Cancer Institute of Emory University; and Emory Healthcare, the largest, most comprehensive health system in Georgia. Emory Healthcare includes: The Emory Clinic, Emory-Children's Center, Emory University Hospital, Emory University Hospital Midtown, Wesley Woods Center, and Emory University Orthopaedics & Spine Hospital. The Woodruff Health Sciences Center has a $2.5 billion budget, 17,600 employees, 2,500 full-time and 1,500 affiliated faculty, 4,700 students and trainees, and a $5.7 billion economic impact on metro Atlanta.

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