On Tuesday, Atlanta-based GeoVax Labs Inc. said it is seeking approval from the Food and Drug Administration to begin a Phase II human trial of its experimental HIV/AIDS vaccine this fall. The trial will be conducted by the National Institutes of Health among 225 healthy volunteers in South Africa and the United States, with support from the HIV Vaccine Trials Network.
The objective is to "further evaluate the safety and immunogenicity of the GeoVax preventative vaccine," said Robert McNally, the biotechnology firm's president and CEO. In addition, GeoVax will evaluate another therapeutic vaccine candidate, he said, that could help HIV patients reduce the amount of drugs they need to control the virus.
In two symptomatic monkeys with simian immunodeficiency virus, the monkey version of GeoVax's vaccine "kept the viral load in check," McNally said. "There was a 100-times reduction in the viral load on one animal and a thousand-times reduction in the second animal," he said. "Those given our vaccine, it slows down or reduces the viral load of the infection. This is significant because it is suppressing AIDS in monkeys, and that's what we are trying to do in people."
Based on those results, "planning for a therapeutic trial in infected and drug-treated humans" has begun, said McNally. "The intent of therapeutic vaccination is for the vaccine to control HIV virus levels in infected individuals to very low levels, thus blocking the development of AIDS," he said.
The monkey study is good news, but also just "one tiny step along the way," said Mitchell Warren, executive director of the nonprofit AIDS Vaccine Advocacy Coalition.
07/09/08
GEORGIA: AIDS Researchers Want Human Test of Vaccine
Source: Atlanta Journal-Constitution:: Bill Hendrick; Courtesy of the CDC National Center for HIV, STD, and TB Prevention