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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
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
"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
-- 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
-- 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
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
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
Source: The Bill & Melinda Gates Foundation