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HIV Vaccine to Begin Human Testing

HIV

This marks a major milestone in HIV/AIDS research.

According to the Baltimore Sun, an HIV/AIDS vaccine developed at the University of Maryland School of Medicine is entering the critical human testing stage.

Dr. Robert Gallo, who heads University of Maryland's Institute of Human Virology and helped discover HIV and developed the blood test to detect it, made the announcement Thursday.

"The results in monkeys are interesting, but they're not perfect," Gallo said. "If we keep just using monkeys, we're never going anywhere. We need for humans to respond."

Scientists at the institute began work on the vaccine 2 decades ago and have seen major breakthroughs in animal testing. UM's vaccine is just one of about 30 similar drugs in some stage of human testing.

The most recent breakthrough came from a 2009 study done in Thailand. There a drug protected one third of of patients against infection. That's not enough to support general use.

Even if the UM drug proves safe and effective, FDA approval is years away and would require more rounds of increasingly complex human trials.

The initial phase, which the institute is entering this month, will make sure the drug is safe for patients and will last about a year. Later rounds would test to see if the drug works as intended.

As of now, the drug is entering what the FDA calls a Phase I trial. 60 people will be enrolled initially and one third will get the drug.

UM's vaccine is designed to target parts of the surface proteins that the virus tries to hide. These parts are common to all strains of HIV.

"Our HIV/AIDS vaccine candidate is designed to bind to the virus at the moment of infection, when many different strains of HIV found around the world can be neutralized," Gallo said. "We believe this mechanism is a major prerequisite for an effective HIV preventive vaccine."

"Can I promise absolute success? No," said Gallo. "Do I hope it leads to a series of advances in the fields? Yes. And I think it will lead to some advances."

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