Gates Foundation Commits $82.9 Million to Develop New Tuberculosis Vaccines

SEATTLE -- The Bill & Melinda Gates Foundation

announces a $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, 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 on Feb. 12, 2004. 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 -- 1 out of every 3 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.

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 percent to 70 percent 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 percent 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."

Aeras will use the grant announced 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, Md., 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.

The Bill & Melinda Gates Foundation is building upon the unprecedented

opportunities of the 21st century to improve equity in global health and

learning. Led by Bill Gates' father, William H. Gates, Sr., and Patty

Stonesifer, the Seattle-based foundation has an endowment of approximately

$26 billion.

Source: The Bill & Melinda Gates Foundation

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