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E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

Vienna, Virginia

* * * * * * * * * * * * * * * * * * * * * * *

UNITED WAY/COMBINED FEDERAL CAMPAIGN

#9119

* * * * * * * * * * * * * * * * * * * * * * *

" Protecting the health and informed consent rights of children since 1982. "

=============================================================================

============

New TB Vaccine Will Begin Tests By End of Year (washingtonpost.com)

How long until this one gets mandated ...

http://www.washingtonpost.com/wp-dyn/articles/A54725-2002Jun3.html

New TB Vaccine Will Begin Tests By End of Year

New Strains Resist Old Drugs

By Okie

Washington Post Staff Writer

Tuesday, June 4, 2002; Page A08

Preliminary testing of a new tuberculosis vaccine in humans is expected to

begin by the end of this year, experts said yesterday. The planned safety

trial would mark the first time in about 80 years that a new vaccine has

been tested against the tuberculosis bacterium, which infects an estimated

one-third of the world's population.

In the past decade, there has been a resurgence of scientific effort and

international funding to fight TB, which kills about 2 million people

worldwide each year, according to health officials and researchers who

spoke to reporters yesterday at the Fourth World Congress on Tuberculosis.

However, bacterial strains that resist treatment with existing drugs are

becoming increasingly prevalent, making the development of new drugs and

vaccines essential to controlling the epidemic.

" We won't even begin to approach the goal of elimination of TB as a global

health problem without developing new tools, " said Philip Hopewell of the

University of California at San Francisco.

There were 15,989 cases of TB reported in the United States last year, half

of them among people born in other countries. Tuberculosis infection may

remain dormant in the lungs for many years, often for a lifetime. In 5

percent to 10 percent of those infected, the disease becomes active,

usually causing fever, night sweats and coughing that can transmit the

bacteria to others.

Someone with active TB must take medicines daily for six to nine months to

halt progression of the disease. The World Health Organization has

spearheaded an approach called DOTS (directly observed treatment,

short-course) to ensure that people with TB take their drugs faithfully,

which increases cure rates and prevents emergence of resistant strains. But

despite expansion of the strategy, especially in China and India, where

one-third of TB deaths occur, currently only 27 percent of the world's TB

cases are detected and treated within DOTS programs, Hopewell said.

People whose immune systems have been damaged by HIV infection are

especially vulnerable to TB, which is a major cause of death among such

individuals, especially in developing countries. Although a full course of

TB treatment costs only $10, not enough money is available to find and

treat all active TB cases worldwide, said Jong-Wook Lee of the World Health

Organization. " The gap is $300 million " annually, he said.

About 15 percent of funds from the new Global Fund to Fight HIV,

Tuberculosis and Malaria have been allocated to tuberculosis detection and

treatment, said Castro of the federal Centers for Disease Control

and Prevention. The Bill and Melinda Gates Foundation is also funding

efforts to develop new vaccines, drugs and tests for TB.

The recent decoding of the genetic sequence of Mycobacterium tuberculosis,

the TB bacterium, represents a potential breakthrough for development of

new drugs and vaccines, said Young of London's Imperial College.

One discovery stemming from new genetic knowledge is that of isocitrate

lyase, an enzyme that TB bacteria apparently need to maintain themselves

even when they are quiescent. Current drugs against the disease can kill

the bacteria only when they are multiplying. A drug that blocked the action

of the enzyme might work better and faster than current treatments, Young

suggested.

The TB vaccine slated for testing in humans later this year is a new

version of BCG, a partially effective vaccine introduced 80 years ago. BCG

is widely used in developing countries to prevent severe TB in childhood.

Developed by California researcher Marcus Horwitz, the new vaccine is

genetically engineered to prompt production of a specific bacterial protein

that has been found to protect mice from the disease, said Carol Nacy of

the Rockville-based Sequella Foundation. The clinical trial, currently

planned to take place in San Francisco, would test the vaccine's safety,

she said.

Other vaccines being developed may be used to boost the immune systems of

TB-infected individuals to reduce their likelihood of developing active

disease, or as an adjunct to drug treatment to prevent relapses, Nacy said.

" We are not anywhere convinced that any of the vaccines [about to undergo]

testing in humans today are going to be the vaccine, " she said. " We simply

have no way to know what is going to work. "

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Guest guest

E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

Vienna, Virginia

* * * * * * * * * * * * * * * * * * * * * * *

UNITED WAY/COMBINED FEDERAL CAMPAIGN

#9119

* * * * * * * * * * * * * * * * * * * * * * *

" Protecting the health and informed consent rights of children since 1982. "

=============================================================================

============

New TB Vaccine Will Begin Tests By End of Year (washingtonpost.com)

How long until this one gets mandated ...

http://www.washingtonpost.com/wp-dyn/articles/A54725-2002Jun3.html

New TB Vaccine Will Begin Tests By End of Year

New Strains Resist Old Drugs

By Okie

Washington Post Staff Writer

Tuesday, June 4, 2002; Page A08

Preliminary testing of a new tuberculosis vaccine in humans is expected to

begin by the end of this year, experts said yesterday. The planned safety

trial would mark the first time in about 80 years that a new vaccine has

been tested against the tuberculosis bacterium, which infects an estimated

one-third of the world's population.

In the past decade, there has been a resurgence of scientific effort and

international funding to fight TB, which kills about 2 million people

worldwide each year, according to health officials and researchers who

spoke to reporters yesterday at the Fourth World Congress on Tuberculosis.

However, bacterial strains that resist treatment with existing drugs are

becoming increasingly prevalent, making the development of new drugs and

vaccines essential to controlling the epidemic.

" We won't even begin to approach the goal of elimination of TB as a global

health problem without developing new tools, " said Philip Hopewell of the

University of California at San Francisco.

There were 15,989 cases of TB reported in the United States last year, half

of them among people born in other countries. Tuberculosis infection may

remain dormant in the lungs for many years, often for a lifetime. In 5

percent to 10 percent of those infected, the disease becomes active,

usually causing fever, night sweats and coughing that can transmit the

bacteria to others.

Someone with active TB must take medicines daily for six to nine months to

halt progression of the disease. The World Health Organization has

spearheaded an approach called DOTS (directly observed treatment,

short-course) to ensure that people with TB take their drugs faithfully,

which increases cure rates and prevents emergence of resistant strains. But

despite expansion of the strategy, especially in China and India, where

one-third of TB deaths occur, currently only 27 percent of the world's TB

cases are detected and treated within DOTS programs, Hopewell said.

People whose immune systems have been damaged by HIV infection are

especially vulnerable to TB, which is a major cause of death among such

individuals, especially in developing countries. Although a full course of

TB treatment costs only $10, not enough money is available to find and

treat all active TB cases worldwide, said Jong-Wook Lee of the World Health

Organization. " The gap is $300 million " annually, he said.

About 15 percent of funds from the new Global Fund to Fight HIV,

Tuberculosis and Malaria have been allocated to tuberculosis detection and

treatment, said Castro of the federal Centers for Disease Control

and Prevention. The Bill and Melinda Gates Foundation is also funding

efforts to develop new vaccines, drugs and tests for TB.

The recent decoding of the genetic sequence of Mycobacterium tuberculosis,

the TB bacterium, represents a potential breakthrough for development of

new drugs and vaccines, said Young of London's Imperial College.

One discovery stemming from new genetic knowledge is that of isocitrate

lyase, an enzyme that TB bacteria apparently need to maintain themselves

even when they are quiescent. Current drugs against the disease can kill

the bacteria only when they are multiplying. A drug that blocked the action

of the enzyme might work better and faster than current treatments, Young

suggested.

The TB vaccine slated for testing in humans later this year is a new

version of BCG, a partially effective vaccine introduced 80 years ago. BCG

is widely used in developing countries to prevent severe TB in childhood.

Developed by California researcher Marcus Horwitz, the new vaccine is

genetically engineered to prompt production of a specific bacterial protein

that has been found to protect mice from the disease, said Carol Nacy of

the Rockville-based Sequella Foundation. The clinical trial, currently

planned to take place in San Francisco, would test the vaccine's safety,

she said.

Other vaccines being developed may be used to boost the immune systems of

TB-infected individuals to reduce their likelihood of developing active

disease, or as an adjunct to drug treatment to prevent relapses, Nacy said.

" We are not anywhere convinced that any of the vaccines [about to undergo]

testing in humans today are going to be the vaccine, " she said. " We simply

have no way to know what is going to work. "

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