Clinical trial of new TB vaccine begins

February 17, 2004

Bethesda, MD - The Aeras Global TB Vaccine Foundation and the David Geffen School of Medicine at UCLA today announced they have begun the first clinical trial of a live recombinant tuberculosis vaccine in the U.S. Six volunteers were inoculated today with the new vaccine at the Center for Vaccine Development, St. Louis University, Missouri, under the direction of Dr. Daniel F. Hoft. Volunteers are also being recruited at another trial site inWinston-Salem, North Carolina, by Piedmont Medical Research Associates under the direction of Dr. Thomas W. Littlejohn III.

The vaccine, known as rBCG30, was constructed by Dr. Marcus Horwitz and his research team at the David Geffen School of Medicine at UCLA. The live vaccine, which uses the current vaccine called BCG (Bacille Calmette-Guérin) as a delivery vehicle, over-expresses the major protein secreted by the TB organism. The Aeras Global TB Vaccine Foundation, the world's only organization dedicated solely to developing and distributing new TB vaccines, conducted the preclinical development and regulatory activities required to begin the study to test the vaccine in humans, in collaboration with Dr. Horwitz.

"The development of the vaccine required a decade-long effort, and we are gratified to see the vaccine progress to clinical trials," said Dr. Horwitz, professor of medicine and microbiology, immunology and molecular genetics at UCLA.

Each year 8 million people develop new cases of TB, and 2 million people die of the disease - nearly all of them in the developing world. The current TB vaccine used throughout most of the world, BCG, is almost a century old and has limited efficacy. In conjunction with drug therapy, a more effective vaccine would greatly reduce the TB disease burden around the world.

First developed and tested in TB-susceptible guinea pigs, the new vaccine was found to be more potent than the commercially available BCG vaccine. Funding for basic research, animal testing and vaccine characterization at UCLA was provided by The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

"We are within reach of new vaccines that could not only save millions of lives, but achieve the longstanding goal of bringing TB under control in the developing world," said Dr. Jerald Sadoff, President & CEO of Aeras Global TB Vaccine Foundation, which is sponsoring the human trial with support from the Bill & Melinda Gates Foundation. "This is the first step in using modern vaccines to defeat this global pandemic."

The bacterium that causes tuberculosis - Mycobacterium tuberculosis - currently infects 2 billion people worldwide, and is the leading killer of people infected with HIV. TB is an airborne bacterial disease that can spread through the lungs to the bones and the brain. Most forms of TB can be treated with drugs, but the complex regimen takes at least six months to complete, and medicine is not always available in developing countries.

The current clinical trial will enroll 30 healthy adults in the U.S. to test the safety of the vaccine and the immune response it provokes. After the trial has been completed, a similar study will be conducted in South Africa, where Aeras has developed a clinical trial site for TB vaccine studies.
-end-
About Aeras: The Aeras Global TB Vaccine Foundation (www.aeras.org) is a non-profit organization working through public-private partnerships to develop new tuberculosis vaccines and ensure that they are distributed to all who need them around the world. The Bill & Melinda Gates Foundation announced last week a grant of USD$82.9 million to Aeras for TB vaccine development. Aeras is led by Dr. Jerald Sadoff, who has obtained licenses for five vaccines commercially and worked on research and development of numerous other vaccine candidates while at Merck and the Walter Reed Army Institute of Research.

About UCLA: The David Geffen School of Medicine at UCLA (http://www.medsch.ucla.edu/) has more than 2,000 faculty including world-renowned experts in clinical practice and scientific research. Many have earned coveted awards such as the Nobel Prize, Pulitzer Prize and National Medal of Science. A relative youngster amongst its peers, the David Geffen School of Medicine at UCLA has emerged as an educational leader, attracting a superb faculty and outstanding students. It ranks in the top 10 U.S. medical schools to receive National Institutes of Health funding.

About St. Louis University: The Center for Vaccine Development at St. Louis University (http://medschool.slu.edu/vaccine/) is a multi-disciplinary research center designed to conduct basic and clinical research on new vaccines and biologics. The Center has demonstrated its ability to recruit large numbers of volunteers and participate in protocols with a wide variety of research designs, vaccine candidates, and subject populations, and has a strong record of cooperating with the National Institute of Allergy and Infectious Diseases (NIAID), other vaccine evaluation units, outside investigators, and industry.

About Piedmont Medical Research: Piedmont Medical Research Associates (http://piedmontmedical.com/pmr/index.htm) is an independent clinical research site in Winston-Salem, North Carolina, that has conducted over 2000 studies since it was founded in 1979.

Contacts:
Rachel Champeau (UCLA - Los Angeles, CA)
310-794-2270
rchampeau@support.ucla.edu

Natalie Waugh (Aeras - Bethesda, MD)
301-547-2917
nwaugh@aeras.org

Aeras

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