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HIV vaccine to start trials

Temper Tantrum

TRIBE Member
HIV vaccine starts trials
Emory-developed formula to begin first full test in humans
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By Erin Moriarty
Atlanta Business Chronicle
Updated: 8:00 p.m. ET April 23, 2006
A promising new HIV vaccine developed in Atlanta is taking a major step forward.

The vaccine, created by Emory researcher Harriet Robinson and an Atlanta biotech company called GeoVax Inc., is moving into human clinical trials.

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This will be the first time the entire vaccine has been tested on humans. Part of the vaccine was used in a preliminary safety trial in 2003, and it showed encouraging results in humans.

But the vaccine faces several rounds of trials, which are likely to take at least four years. The vaccine won't be available until all of the trials are completed and the drug gets approval from the Food and Drug Administration.

Robinson and a team of researchers first tested the vaccine in rhesus monkeys at the Yerkes National Primate Research Center at Emory University.

In those trials, the vaccine protected 96 percent of the monkeys for more than three and a half years -- giving researchers hope that their vaccine could be used in humans to help prevent the deadly virus that kills several million people each year.

The vaccine has been years in the making. Robinson, who first began researching HIV vaccines in 1992, began a trial in 1999 in rhesus monkeys that laid the foundation for this current vaccine. Robinson later teamed up with pharmaceutical veteran Don Hildebrand to start GeoVax in order to further develop the vaccine.

The human clinical trial will be very important, said Robinson, who is chief of microbiology and immunology at the Yerkes research center. "The results will indicate to us whether it will perform the same as it did in rhesus monkeys."

The vaccine for humans uses a two-part strategy -- it gives patients two shots of a DNA vaccine that primes the immune system to recognize HIV, and two doses of subsequent booster vaccine to enhance the body's immune response. The doses are given several weeks apart.

The vaccine works by producing some of the proteins expressed by HIV in order to induce the immune system to respond should the body later be exposed to HIV. It does not contain the "live" or complete virus, so it could not cause the onset of HIV, researchers say.

The vaccine is different from other HIV vaccines being developed, said Hildebrand, a microbiologist by training who worked in pharmaceuticals and vaccines for three decades.

"The proteins that we're using in our vaccines very much mimic the ones that are naturally found in the AIDS virus, and we believe that the immune responses to those more naturally appearing antigens may be more effective in destroying the actual AIDS virus when it comes in contact with it," said Hildebrand, who was previously North American president and CEO of Rhone Merieux Inc./Merial Ltd.

He also added that the vaccine stands out because it stimulates "an impressive breadth of immune responses" in a vaccinated person to the AIDS virus, thus reducing the opportunity for the AIDS virus to mutate and cause AIDS.

"We think it has great promise," said Hildebrand, CEO of GeoVax. "This vaccine technology has a chance to really work."

The clinical trial will begin this month at several sites around the country, including the University of Alabama at Birmingham, Saint Louis University, the University of Maryland, the University of Rochester and Vanderbilt University.

It is being conducted through the HIV Vaccine Trials Network, which is funded by the National Institutes of Health.

This trial, which will give low doses of the vaccine to volunteers, will be the first of many. If the vaccine proves safe after this trial, another trial will begin with high doses. If the high doses are proven safe, then a third trial will be conducted to figure out the best dosing schedule for the vaccine.

Those phases will take three to four years and will use only volunteers who are not high-risk for getting HIV, Robinson said.

Then, the trials would move into testing volunteers who are at a high risk for contracting HIV.

Researchers say there is an acute need for a vaccine.

"There is a tremendous urgency because there are 14,000 to 16,000 new infections a day, so every day we're stalling, that's a lot of infections," Robinson said. "In the United States, people have reasonable access to drugs so with drugs they can survive for another 25 years, but if you are in Africa, there are countries where the life expectancy is now 39 years."

There are about 1 million people infected with HIV in the United States and an estimated 40 million people living with HIV/AIDS worldwide. More than 3 million people died from AIDS in 2005 alone, according to the World Health Organization.

"It's everywhere and it's continuing to increase," Hildebrand said. "Drug treatment programs -- while they prolong life and make people a little bit more comfortable -- are not a long-term solution. A vaccine that prevents the clinical disease is the only real solution."

© 2006 Atlanta Business Chronicle


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Kiera

TRIBE Member
Wow, that sounds promising. It would be nice if we could finally find a cure for this horrific disease. Then we could move on and find cures for other diseases.
 

KillaLadY

TRIBE Member
Umm, they are already doing this at my clinic since last fall.

It's not a cure, it has two purposes:

~ may help in prevention of aquiring the virus
~ if virus is aquired, then monitor patient to see if she/he's a slow-progressor.

Interesting stuff, especially since we ran into a lot of ETHIC problems (our posters, the way this vaccine approaches the community, etc etc)
 
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