Gates Foundation Commits $82.9 Million to Develop New Tuberculosis Vaccines

SEATTLE -- The Bill & Melinda Gates Foundation announced today an $82.9 million grant to the Aeras Global TB Vaccine Foundation to support development of new vaccines to prevent tuberculosis, a disease that kills nearly two million people every year. The grant, the largest ever for TB vaccine development, will allow Aeras to fund human trials of promising TB vaccines and early research on the next generation of vaccines.

Dr. Richard Klausner, former executive director of the Gates Foundation's Global Health program, announced the grant at the opening session of the American Association for the Advancement of Science annual meeting in Seattle. The grant will more than double the amount spent annually on TB vaccine research worldwide.

"It's unacceptable that TB continues to kill someone every 15 seconds when we have the ability to discover new tools to stop it," Klausner said. "Through accelerated research and development, a new vaccine could permanently change the trajectory of the epidemic and save millions of lives every year."

Two billion people—one out of every three people on earth—are infected with the TB pathogen. TB is the leading killer of people infected with HIV. Fueled by the HIV/AIDS epidemic, TB is resurgent in the developing world, and the World Health Organization projects that 36 million people could die of the disease over the next 20 years. 

New TB Vaccine Urgently Needed

A new vaccine is the key to controlling TB, an airborne, contagious bacterial disease that begins with a cough but can rapidly spread to the lungs, bones and brain.  While TB can be treated, the basic treatment regimen takes at least six months to complete and requires as many as four different drugs, which are often unavailable in developing countries.  Modeling studies show that a modestly effective vaccine (50%-70% effective) used in combination with drug therapy could save tens of millions of lives, and a highly effective vaccine could eventually control the disease.

The existing TB vaccine, BCG (Bacille Calmette-Guerin), has been in use since the early 1900s and is administered to millions of newborns around the world. BCG appears to reduce the risk of serious childhood forms of TB. However, the high incidence of TB in developing countries where infant BCG immunization is widely practiced indicates that BCG is not highly efficacious over the many years that people are at risk for the disease.

Dr. Jerald Sadoff, President and CEO of the Aeras Global TB Vaccine Foundation and the former Clinical Director for Vaccine Development at Merck, was optimistic about the prospects for a new TB vaccine.

"Our goal—and we believe it is achievable—is to license and deliver a more effective TB vaccine within 10 years," Sadoff said.  "About 90% of people infected with the TB pathogen never get sick, which indicates that there is some natural immunity against the disease. This grant allows us to develop leading vaccine candidates today and explore new research paths that could lead to even better vaccines in the future."

Grant to Advance Research on Promising TB Vaccines

Aeras will use the grant announced today to support research in three major areas:

- Vaccine trials:  Aeras will sponsor Phase II trials of a combination of two promising TB vaccines. The first vaccine, known as rBCG30, is an enhanced version of the BCG vaccine that has been genetically engineered to stimulate a stronger immune response.  Aeras began a Phase I clinical trial of rBCG30 in the U.S. in January 2004. The second, a fusion protein, is a new vaccine that combines two proteins from the TB pathogen that are primary targets of the immune system.  rBCG30 will be used to "prime" the immune system to control TB, and  the fusion protein will provide an additional "boost" to the body’s response to infection.  Previous research has demonstrated that this "prime-boost" approach often results in enhanced protection in animal models.

- Improved animal models:  Aeras will also study the ability of animal models to predict vaccine effectiveness in humans. Finding such predictive models will greatly accelerate future TB vaccine research.

- Next-generation vaccines:  Aeras will also support early research on the next generation of TB vaccines. Researchers will construct and evaluate several leading candidates, and prepare the most promising ones for human trials.

Aeras, which is based in Bethesda, Maryland, will implement this research in partnership with scientists, academic institutions, governments, and companies in the U.S., Europe, South Africa, and other developing countries.  Aeras has already established a clinical research site in Cape Town, South Africa, where more than 9,000 volunteers are enrolled in a clinical trial, and other sites are being considered in Peru and India.  Aeras is also partnering with The Biovac Institute in Cape Town to manufacture vaccines for future Phase I and II clinical trials.  Following an "industrial model" of vaccine development, Aeras will prioritize the vaccine pipeline into primary and back-up candidates, and adhere to strict timelines and predetermined "go/no go" criteria.

Sadoff emphasized that more resources are needed to support TB vaccine research efforts.  "We hope that the Gates Foundation grant will leverage much-needed support from other donors, both in the U.S. and worldwide," he said.

Klausner stressed that as TB vaccine research moves forward, it is also important to increase research on TB drugs and diagnostics, and expand global access to existing TB prevention and treatment efforts. The World Health Organization has estimated that total resources for TB research and control from 2001-2005 will fall about $3.8 billion short of the need. To date, the Gates Foundation has provided a total of $217 million in grants to TB research and control programs.

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The Aeras Global TB Vaccine Foundation works through public-private partnerships to develop new tuberculosis vaccines and ensure that they are distributed to all who need them. Aeras is led by Dr. Jerald Sadoff, who has licensed five vaccines commercially and developed numerous other vaccine candidates while at Merck and the Walter Reed Army Institute of Research.

On the Internet:
Bill & Melinda Gates Foundation, www.gatesfoundation.org
Aeras Global TB Vaccine Foundation, www.aeras.org