A non-profit US research group has just launched a state-of-the-art tuberculosis vaccine manufacturing facility.  The Aeras Foundation lab, located in Rockville, Maryland outside of Washington, DC, will be able to produce 200 million doses of new formula, enough quantity to meet current worldwide needs to fight a global TB epidemic.  The research laboratory was inaugurated Tuesday, with US and local public officials in attendance.

Several new vaccines being created and tested will soon supplement the traditional, but limited BCG vaccine for tuberculosis that was developed in 1921. Aeras senior director for external affairs Peg Willingham confirms that the recently designed medications, engineered with support from the Bill and Melinda Gates Foundation, are the first new TB vaccines to emerge in 88 years.

?The world really needs a new, improved, safer, and more effective TV vaccine, and that?s why Aeras was founded about six years ago to both do vaccine discovery and manufacture.  The heart of our work is the clinical trials that are being conducted in several countries in Africa, the countries that have the highest rates of TB,? she explained.

Some early-stage safety testing was conducted on the new drugs in the United States and Europe.  But Willingham says critical clinical trials on four potential vaccines are currently taking place in Africa, with the goal of delivering inoculations in bulk, vials, powder, and aerosol forms to countries in Africa and throughout the developing world, where they are most needed. 

?Currently in Africa, there are trials in South Africa and in Kenya.  And we?re expecting to do trials in Uganda and in Mozambique.  The country that?s doing the most tuberculosis vaccine clinical trials is South Africa through a partnership with the University of Cape Town.  There?s an organization called the South African Tuberculosis Vaccine Initiative, and they are hosting trials of four different vaccines right now,? Willingham noted.

It?s estimated that one-third of the world?s population is infected with TB.  In most people it is only barely detectable.  Many don?t even realize they have it.  But a smaller, critical percentage of those infected with TB become incapacitated or faced with life-threatening circumstances.  Tuberculosis kills 1.8 million people every year, and with drug resistant forms of TB advancing globally, a deadly relationship has developed between TB and HIV, the virus that causes AIDS, particularly in defenseless areas of the developing world.  Because it weakens the body?s defenses to a point where it is impossible to fight off other serious afflictions, TB is now the leading cause of death among people co-infected with HIV in Africa. Willingham says that only intensifies the need to provide safe vaccines that African TB patients who are also infected with HIV can depend on.

?Our goal is to develop vaccines that would be safe for use in people living with HIV and people of all ages and against drug-resistant TB.  We have six different vaccines in our pipeline, four of which are in trials, and two more we hope to have in trials.  One of the vaccines already has been tested, and people living with HIV already can safely use most vaccines that are on the market.  The ones that they should avoid would be live vaccines.  One is in fact, the BCG that currently is available and that does pose some safety risk for people with HIV.  TB-HIV co-infection is a very serious health problem, and unfortunately seems to be growing.  And so it?s absolutely vital that our vaccine be safe and effective for use in people with HIV,? she noted.