*EPF108 09/20/2004
Text: CDC Funds Studies for Tuberculosis Vaccine Trials
(Aeras Foundation helps prepare for vaccine clinical trials in India) (1000)

The U.S. Centers for Disease Control and Prevention (CDC) has announced a $925,000 cooperative agreement with the Aeras Global TB Vaccine Foundation to conduct epidemiologic studies in preparation for clinical trials of new tuberculosis (TB) vaccines in India.

According to a September 17 CDC press release, the cooperative agreement with CDC is the first government contribution to Aeras, a leading organization working to develop new vaccines against TB, a bacterial disease that kills 2 million people worldwide each year. The funding is renewable for up to three years.

The leading killer of people living with HIV/AIDS, TB is one of the most prevalent infectious diseases in the world, and fully one third of the global population has been infected. The currently available vaccine, BCG, is nearly a century old and rarely protects beyond early childhood.

Aeras will work with the CDC and collaborators at the St. John's National Academy of Health Sciences in Bangalore, India, to develop and expand sites for Phase II and Phase III clinical trials in Palamaner Taluk, Andhra Pradesh, India.

The cooperative agreement will help Aeras create a professional development program for staff in India, develop laboratory capacity for TB diagnosis and referral systems to treat and cure patients, examine TB incidence and prevalence, and further study TB incidence among newborns and adolescents in this southern part of India.

In making the award, the CDC recognized Aeras for "innovative work in advancing the field of TB vaccine development" and cited the organization's history of collaboration with international partners in South Africa, Europe and Asia. Aeras is based in Bethesda, Maryland.

Additional information on the foundation may be viewed at http://www.aeras.org/index.html

The text of the CDC press release follows:

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Centers for Disease Control and Prevention
Press release, September 17, 2004

Aeras Receives CDC Funding to Develop TB Vaccine Trial Sites in India

3 year, $2.7 Million Award to Prepare for Testing New TB Vaccines

Bethesda, Md., Sept. 17, 2004 --Aeras Global TB Vaccine Foundation today announced a $925,000 cooperative agreement from the US Centers for Disease Control and Prevention to conduct epidemiologic studies in preparation for clinical trials of new tuberculosis (TB) vaccines in India. The funding is renewable for up to three years. Aeras has received major funding from the Bill & Melinda Gates Foundation, but the cooperative agreement with CDC marks the first government contribution to Aeras, the world's leading organization working to develop new vaccines against TB, a bacterial disease that kills 2 million people worldwide each year.

"We look forward to working with the CDC to rapidly move promising vaccine candidates into clinical trials," said Aeras CEO Dr. Jerald Sadoff. "This critical support from the US government marks significant progress in addressing the serious shortfall in international TB vaccine funding and will hasten the day when an effective vaccine is available."

Aeras will work with the CDC and collaborators at the St. John's National Academy of Health Sciences in Bangalore, India to develop and expand sites for Phase II and Phase III clinical trials in Palamaner Taluk, Andhra Pradesh, India. The cooperative agreement will help Aeras create a professional development program for staff in India, develop laboratory capacity for TB diagnosis and referral systems to treat and cure patients, examine TB incidence and prevalence, and further study TB incidence among newborns and adolescents in this southern part of India.

The funding will be used to prepare the site to administer later phase trials of the leading vaccine candidates now being developed by Aeras. The leading killer of people living with HIV/AIDS, TB represents one of the most prevalent infectious diseases throughout the world. The currently available vaccine, BCG, is nearly a century old and rarely protects beyond early childhood.

Although spending on TB vaccine research accounts for only a small fraction of funding dedicated to vaccine research for other diseases, TB vaccine development has made rapid progress in recent years. The Bill & Melinda Gates Foundation more than doubled the level of global TB vaccine funding in February 2004 with an $82.9 million grant to Aeras, and it is likely that at least six phase I trials of TB vaccine candidates will be initiated between 2002 and 2005. Despite the Gates grant and the promise of new collaboration with the CDC, Aeras must raise over $250 million to fully fund its scientific program between now and 2010.

In making the award, the CDC recognized Aeras for "innovative work in advancing the field of TB vaccine development" and cited the organization's history of collaboration with international partners in South Africa, Europe and Asia. The CDC also acknowledged the important field of vaccine development in combating a disease that has mutated into drug-resistant strains and requires a complex treatment regimen.

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. President & CEO Jerald Sadoff, MD, heads Aeras. Dr. Sadoff has previously overseen FDA licensure of five vaccines and worked on the research and development of numerous other vaccine candidates while at Merck and the Walter Reed Army Institute of Research.

About CDC

The Centers for Disease Control and Prevention (CDC) (www.cdc.gov) is recognized as the lead federal agency for protecting the health and safety of people -- at home and abroad, providing credible information to enhance health decisions, and promoting health through strong partnerships. CDC serves as the national focus for developing and applying disease prevention and control, environmental health, and health promotion and education activities designed to improve the health of the people of the United States.

CDC, located in Atlanta, Georgia, USA, is an agency of the Department of Health and Human Services. Dr. Julie L. Gerberding is the Director.

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(Distributed by the Bureau of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)

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