Tuberculosis Treatment

Clinical Trial For New Tuberculosis Vaccine

2008-10-10T07:51:00.000-07:00

With annually 2 million deaths and 9 million new cases, there are more victims of tuberculosis than of any other infectious disease, apart from AIDS. To make the situation worse, many strains of tuberculosis are so resistant that they no longer respond to traditional treatment, making the necessity of a new tuberculosis vaccine more urgent than ever.

For the first time in 80 years, a very promising live tuberculosis vaccine has reached the clinical trial stage in Germany.

Since Monday of this week, the new vaccine "VPM1002" has entered the clinical phase I trial in Neuss, Germany, where it is being tested for safety on voluntary subjects. VPM1002 is based on a vaccine that has been in use since 1921, and has been genetically engineered to prevent infection with tuberculosis bacteria much more effectively than its predecessor.

The scientific basis for this was laid down by the team working with Stefan H.E. Kaufmann, Director at the Max Planck Institute for Infection Biology. "The BCG tuberculosis vaccine, which was developed by French researchers, is the most frequently administered live vaccine in the world," says Kaufmann. However, BCG (short for the bacterium Bacillus Calmette-Guérind) is now frequently ineffective. The immunologist continues: "BCG has become a blunt weapon. We wanted to use genetic engineering to sharpen it so that, rather than hiding from the human immune system, it would stimulate it as much as possible."

To do this, the researchers inserted a gene into the vaccine bacteria. Leander Grode, who at the time was a member of Stefan H.E. Kaufmann’s staff and is today heads a project at Vakzine Projekt Management GmbH (VPM), describes the process: "The vaccine bacteria are taken up by the scavenger cells of the human immune system and end up in their digestion chambers. The genetically engineered modification allows them to escape from the chambers and arm the immune system against the tuberculosis pathogens."

The scientific studies were initially undertaken at the Max Planck Institute for Infection Biology. In 2004, the vaccine was licensed to the Hanover-based VPN, which expedited the clinical study. Thus far, the new vaccine has proven to be extremely effective and safe in animal models. "We now need to prove that it has the same positive effect on humans, so that it qualifies for a license," explains VPM CEO Bernd Eisele. Kaufmann urges patience: "Even if the new vaccine proves to be well-tolerated, it will still have to undergo more testing to establish its efficacy. That will take at least ten years." Nevertheless - this new approach is looking hopeful.

The establishment of the Max Planck Institute for Infection Biology in 1993 was one of the first in the newly-formed German states (which previously had made up East Germany). The Institute is located on the historical Charité Mitte campus, where, 100 years ago, Robert Koch and Emil Behring made important discoveries about infectious diseases. A key reason for choosing this location was the desire to work together with the universities and clinics on clinically relevant infectious disease projects.

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What is Tuberculosis?

2008-09-25T10:40:00.000-07:00

Tuberculosis (TB) is an infectious disease caused by bacteria whose scientific name is Mycobacterium tuberculosis. It was first isolated in 1882 by a German physician named Robert Koch who received the Nobel prize for this discovery. TB most commonly affects the lungs but also can involve almost any organ of the body. Many years ago, this disease was referred to as "consumption" because without effective treatment, these patients often would waste away. Today, of course, tuberculosis usually can be treated successfully with antibiotics.

There is also a group of organisms referred to as atypical tuberculosis. These involve other types of bacteria that are in the Mycobacterium family. Often, these organisms do not cause disease and are referred to a "colonizers," because they simply live alongside other bacteria in our bodies without causing damage. At times, these bacteria can cause an infection that is sometimes clinically like typical tuberculosis. When these atypical mycobacteria cause infection, they are often very difficult to cure. Often, drug therapy for these organisms must be administered for one and a half to two years and requires multiple medications.

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Tuberculosis Causes.

2008-09-25T10:11:00.000-07:00

All cases of TB are passed from person to person via droplets. When someone with TB infection coughs, sneezes, or talks, tiny droplets of saliva or mucus are expelled into the air, which could be inhaled by another person.
Once infectious particles reach the alveoli, small sacs in your lungs, another cell called the macrophage engulfs the TB bacteria.
Then the bacteria are transmitted to your lymph system and bloodstream and spread to other organs.
The bacteria further multiply in organs that have high oxygen pressures, such as the upper lobes of your lungs, your kidneys, bone marrow, and meninges—the membranelike coverings of your brain and spinal cord.
When the bacteria cause clinically detectable disease, you have TB.
People who have inhaled the TB bacteria, but in whom the disease is controlled are referred to as infected. They have no symptoms, frequently have a positive skin test, yet cannot transmit the disease to others.

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Treatment Alternatives.

2008-09-25T09:52:00.000-07:00

¿What is Myambutol (Ethambutol)?

Myambutol is an antibiotic. It prevents growth of the tuberculous bacteria in the body. Myambutol is used to treat tuberculosis (TB). Myambutol may also be used for purposes other than those listed in this medication guide.

¿What is the most important information I should know about Myambutol (Ethambutol)?

Take all of the Myambutol that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated. Call your doctor immediately if you experience changes in vision (e.g., blurring, red-green color blindness) or a rash.

¿What is Rifampin?

Rifampin is an antibiotic. Rifampin prevents bacteria from spreading in your body. Rifampin is used to treat or prevent tuberculosis (TB). Rifampin may also be used to eliminate a bacteria from your nose and throat that may cause meningitis or other infections, even if you do not have an infection. Rifampin prevents you from spreading this bacteria to other people, but the medication will not treat an infection caused by the bacteria.

¿What is the most important information I should know about Rifampin?

Use the Rifampin for as many days as it was prescribed for you, even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated. Rifampin will not treat a viral infection such as the common cold or flu. Call your doctor immediately if you experience a fever, chills, sore throat, joint pain or swelling, excessive tiredness or weakness, unusual bleeding or bruising, skin rash or itching, loss of appetite, nausea, vomiting, or yellowing of the skin or the whites of your eyes.

Take the Rifampin capsule on an empty stomach 1 hour before or 2 hours after a meal. Rifampin may decrease the effectiveness of birth control pills. Talk to your doctor about using another form of birth control during treatment. Injectable Rifampin should be administered only under the supervision of a qualified healthcare provider.

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