New TB Vaccine Goes on Trial

Medical Authors and Editors: Barbara K. Hecht, Ph.D. and Frederick Hecht, M.D.

Jan. 27, 2004 -- A promising new vaccine for tuberculosis (TB) is about to go into a clinical trial, according to a press release (below) from the National Institute of Allergy and Infectious Diseases (NIAID).

The new vaccine combines two TB proteins that stimulate strong immune responses in humans. These proteins were identified by screening blood samples from people who never became ill with tuberculosis despite long-term infection with the bacteria Mycobacterium tuberculosis, which causes the disease.

The two TB proteins were fused by recombinant DNA technology, and then combined with adjuvants, substances that further boost the immune system's response to the vaccine.

The New Vaccine in Perspective

Anthony S. Fauci, MD, Director of NIAID provided perspective on the new vaccine.

"This is the first recombinant tuberculosis vaccine to reach human trials in the United States," said Dr. Fauci. "Indeed, this is the first new TB vaccine to be tested in our country in more than 60 years. This candidate vaccine, as well as other novel products emerging from the TB research and development pipeline, offers hope for reducing the burden of a disease that claims approximately two million lives each year."

Tuberculosis in the Past

Evidence of tuberculosis has been found in the spines of Egyptian mummies thousands of years old. The disease was common both in ancient Greece and Imperial Rome. Hippocrates, the ancient Greek physician, identified phthisis (which means wasting) as the most widespread, and invariably fatal, disease of his time.

Over its long history, the disease caused by Mycobacterium tuberculosis has gone by many names. These names include phthisis, consumption, the English Disease, White Plague, decay, tuberculosis, and TB. Irrespective of name, the disease has always provoked respect, and fear.

In the 17th century, the English writer John Bunyan dubbed it "the Captain of all the men of death." And in the 19th century, consumption, with its symptoms of bloody cough, fever, pallor and long, relentless wasting, was immortalized in opera, fiction, and art.

But after World War II, tuberculosis appeared about to meet its own doom, thanks to the advent of antibiotics,

Tuberculosis Today

Around 1985, the numbers of cases of TB began to rise in the United States. Several interrelated factors were responsible for the resurgence of TB.

Key factors underlying the resurgence included increases in prison populations, homelessness, and injection drug use, as well as crowded housing and increases in populations of long-term care facilities. These conditions are ideal for the transmission of TB.

Then, in recent decades the United States has experienced increased immigration of peoples from countries where TB is endemic, countries where TB has long been an everyday fact of life.

The most fuel was tossed on to the fire by the HIV/AIDS epidemic and by the emergence of multidrug-resistant TB (MDR-TB). People with HIV tend to be susceptible to TB. And MDR-TB has been a very formidable adversary in the US and elsewhere in the world.

TB today causes more deaths than any other single infectious organism. Some 1.8 billion people -- a third of the world's population -- are infected with the bacterium of tuberculosis and between two and three million die of tuberculosis each year.

A new TB vaccine is badly needed. We hope it is a good one.

Reference: National Institute of Allergy and Infectious Diseases, National Institute of Health Press Release, January 26, 2004

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