WASHINGTON – A Maryland biomedical research company said Tuesday that the Food and Drug Administration has cleared the way for human trials to begin on an HIV vaccine it helped develop.
Kensington-based Advanced BioSciences Laboratories developed a protein that — when used in conjunction with a vaccine based on the DNA of five different strains of HIV — allows the body to develop antibodies to the virus that causes AIDS.
The vaccine was created by the University of Massachusetts. It takes the unusual approach of attacking several types of HIV at once, said Dr. Jeff Kennedy, who will be directing the clinical trials for the university.
“No one, up to this point, has ever tried to induce a broad immune response, where the immune response is handed a shotgun instead of an M-16,” Kennedy said. “The traditional methods of creating a vaccine weren’t going to work. . . . We needed to try the next level of vaccine development.”
One advantage of the shotgun approach is that it should counter the virus’s ability to evolve quickly, Kennedy said.
Last year, about 3 million people died of AIDS worldwide, according to the Centers for Disease Control and Prevention, and there are about 40 million people living with HIV today. The latest figures for Maryland show that 1,854 people died of AIDS in the state during 2002, according to Kaiser Family Foundation.
The experiments — expected to begin in April — will take place at the University of Massachusetts in Worcester, Mass., which has already begun to seek volunteers, Kennedy said.
The first phase of human trials will include 36 people who will each take three doses of the DNA element of the vaccine and two doses of the protein during a 12-month period, according to CytRx Corp. of Los Angeles, which would hold commercial rights to the vaccine.
The partnership between CytRx, Advanced BioSciences Laboratories and the university is one of four funded by a $70 million National Institute of Allergy and Infectious Diseases project that works with private companies to develop a vaccine for HIV.
Dr. Stuart Shapiro, of the institute, said he expects about a dozen HIV vaccines to be introduced into clinical trials this year, signaling a new approach for the institute in which it is trying several vaccines instead of a handful.
“The good news is that we are priming the pump,” Shapiro said. “The NIH (National Institutes of Health) has really been an organization that funds basic research. With this . . . we are preparing to promote products.”
Shapiro said that DNA vaccines could be a great benefit to the industry. Because the vaccines are very similar to each other, he said, it should make it easier for companies to get into the business.
“In the future, if the DNA vaccines work for HIV, people may shift to using those for all diseases,” Shapiro said.
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