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Latest Results Spur Intensified Effort Toward HIV Vaccine

Monday, February 24, 2003

Today’s announcement by VaxGen Inc. of the results of the first study to test how well a vaccine prevents infection from the AIDS virus in high-risk volunteers is spurring an intensified effort among University of Rochester researchers to test this and other potential AIDS vaccines.

 Early today, VaxGen announced that a vaccine tested in 5,400 volunteers at 59 sites in North America and Europe, including 62 volunteers in the Rochester area, was not effective in preventing infection overall. However, the findings come with a surprising twist – the study suggests that the vaccine may be able to offer some protection to Black and Asian volunteers who participated.

The results are galvanizing the determination of researchers to move the development of variations of this vaccine and other potential HIV vaccines along as quickly as possible.

“We can’t let up now,” says Michael Keefer, M.D., associate professor of medicine, who directs the HIV Vaccine Unit at the University of Rochester Medical Center. “We continue to learn about HIV at an incredible pace, and today’s announcement adds another piece to the puzzle, as well as perhaps an important clue in the intriguing findings in African-American volunteers. We will build on these results to move forward and test more vaccines in an effort to protect more people from this devastating disease.

“It’s an urgent need – every six seconds on average somewhere in the world, another person is infected with HIV. The finding that African Americans were protected in part by this vaccine is heartening, since that population makes up a large percentage of newly infected individuals in the United States. Since we’re about to begin a new study that targets the form of HIV prevalent in Africa, we’re especially hopeful that these findings can some day be extended to Blacks in Africa, where the need for an effective preventive HIV vaccine is even greater.”

 Nearly all of the dozens of HIV vaccine studies done in people so far have focused on their safety and their ability to provoke an immune response as measured in laboratory tests. The VaxGen study is the first to look at how well a vaccine actually works at preventing people at high risk from getting HIV; the vaccine candidate, AIDSVAX, was the first in the world to reach this stage of testing.

HIV attacks the immune system, leaving the body vulnerable to infections that most people fight off routinely. Every day, about 15,000 people worldwide are infected with HIV. The disease has infected about 42 million people globally, including about 1 million people in the United States; more than 90 percent of those infected live in Africa and other developing regions of the world.

Volunteers in Rochester have played a substantial role in helping researchers learn more about vaccines since such studies began 15 years ago. Local residents have taken part in more than three dozen studies that have helped doctors learn more about what will ultimately constitute an effective HIV vaccine. Nearly 700 volunteers from Rochester have participated, a rate of volunteering that is among the highest of any region in the world. Previously 109 volunteers from Rochester participated in earlier studies to assess the safety of the VaxGen vaccine.

The University’s HIV vaccine unit is currently testing four potential HIV vaccines and is about to begin evaluating six more – all potential HIV vaccines are synthetic and cannot cause infection. For these 10 studies, a total of more than 100 volunteers is needed locally. Volunteers should be between the ages of 18 and 50, in good health, and not infected with HIV.

“Volunteers are typically healthy people who want to do something to stop the AIDS pandemic,” says Keefer. “Oftentimes our volunteers are friends or family members of people who have been affected by the disease. Sometimes they’re simply people who want to play a role in solving this awful problem and help future generations.

“The participation of such volunteers is crucial. Without them, efforts to develop a vaccine to stop the spread of AIDS would grind to a halt. Today’s results demonstrate that now is the time to renew our efforts to put an end to this disease.”

The University’s HIV vaccine unit is one of 25 sites worldwide that make up the global HIV Vaccine Trials Network, or HVTN, run by the National Institute of Allergy and Infectious Diseases. Rochester is one of only four sites nationwide that has been working on a vaccine since the first units were created in 1988, and it serves as a model for a sister site in Rio de Janeiro.

 “There’s been an explosion in our knowledge about the virus in the 20 years we’ve known about it,” says Keefer. “Vaccine development takes years, and the results we’re hearing about today have their inception in technology that is more than 10 years old. It’s an ongoing process, and we’ve learned a lot over this time. Fortunately there are many new ideas that we are testing right now and will be for years to come.”

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