New NIH center focuses on finding an AIDS vaccine

Although HIV is the priority, the Vaccine Research Center is also looking at smallpox, West Nile virus and Ebola.

By Susan J. Landers, AMNews staff. April 7, 2003.

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Washington -- If new labs with the latest equipment operated by an assembly of top-notch scientists and backed by federal funds can make a difference in the fight against the AIDS virus, the National Institutes of Health Vaccine Research Center stands ready.

It is the first facility at NIH dedicated solely to vaccine research and production and, for now at least, is focusing its formidable resources on the development of an AIDS vaccine. As a result, it is uniquely positioned to take a promising vaccine candidate from basic research through preparation of a vaccine and animal testing and on to clinical trials in people.

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The six-story center opened in September 2000 and, within its first year, had launched an AIDS vaccine trial -- a rapid pace by anyone's measure. Described as a cross between a biotechnology company and an academic organization, its quest is a vital one as approximately 40,000 Americans and untold thousands more around the world continue to become infected with the virus each year.

"There are no other centers like this center where there is a group of scientists together in one building whose major focus is the development of an AIDS vaccine," said Gary J. Nabel, MD, PhD, director of the facility, which is formally known as the Dale and Betty Bumpers Vaccine Research Center.

Dr. Nabel is also a hands-on researcher who heads up the center's virology lab, just down the hall from his small office on the fourth floor. He has another, much larger first-floor office, with a yellow and blue Keith Haring sculpture just outside. But he doesn't spend much time there, said Abe Mittelman, MPH, associate director for management and operations at the center, preferring instead to be closer to the action.

The VRC was established by NIH to respond to a goal set by former President Bill Clinton in 1997 to develop an AIDS vaccine within 10 years. It is officially a part of the National Institute of Allergy and Infectious Diseases. And, although many believe the 10-year time frame is a bit tight in light of all that is being learned about the elusive virus, Dr. Nabel views it as a yardstick in considering whether researchers are on the right track.

"I do think by 2007 we should know if we have candidates that look viable and whether [a vaccine] is going to be something that is going to make a significant difference in this viral pandemic," Dr. Nabel said.

If the vaccine course seems promising, an all-out effort will be made to bring successful candidates to the marketplace as fast as possible, he said. "And if not, we need to start looking at other measures to prevent transmission, whether they be more acute drug treatment, more education, more emphasis on types of behavioral modifications that could reduce transmission. Obviously we need to keep a full-court press on any possible way to reduce transmission of this disease."

The singular goal to combat HIV was set well before Sept. 11, 2001, and the fears of a bioterrorist attack that have developed since. The center's role has expanded to include studies evaluating a safer smallpox vaccine, Dr. Nabel said. Work also is being done on a West Nile virus vaccine, and Dr. Nabel is continuing to work on a vaccine for the Ebola virus that he began as a professor at the University of Michigan in Ann Arbor.

The center also may have a role in the Bush administration's proposed Project BioShield. That project is intended to join researchers, medical experts and the industry to focus on medical countermeasures to dangerous biological and chemical agents. The proposal recently gained approval from the Senate Health, Education, Labor and Pensions Committee.

Meanwhile, the VRC continues to focus on an AIDS vaccine, with clinical tests under way on a vaccine that is directed at the three most common HIV subtypes, or clades.

Those three clades account for more than 90% of cases worldwide, Dr. Nabel said. "We call it our global vaccine candidate."

The candidate is a DNA vaccine that incorporates parts of four HIV genes. Three of the components are modified versions of HIV genes called "gag," "pol" and "nef," taken from clade B, the subtype that predominates in Europe and North America. The fourth vaccine component is derived from an HIV gene called "env."

The env gene codes for a protein on the outer coat of the virus that allows it to recognize and attach to human cells. Center scientists are the first to combine modified env from clades A and C, which are the most common in Africa, as well as from clade B.

While the gene fragments have been shown to stimulate an immune response, they cannot cause infection, Dr. Nabel said.

The vaccine is now in a phase I trial to determine its safety. So far, it has gone well, Dr. Nabel said.

A key player

The center is extremely important in the fight against AIDS, said Jeffrey Laurence, MD, professor of medicine at Cornell Medical College and senior scientist at the American Foundation for AIDS Research. Two decades into the battle to defeat the disease, nothing simple has worked, he said.

Dr. Laurence referred to the recently concluded VaxGen phase III trial as one of several failed efforts. He looks to the VRC as being well-positioned to provide a type of centralized authority that could, perhaps, prioritize future phase III AIDS vaccine trials so a generous pool of volunteers will continue to be available.

He fears that the VaxGen trial so dashed the hopes of participants that they will be unwilling to participate in future trials.

Pat Fast, MD, PhD, medical director of the International AIDS Vaccine Initiative, praised the center's ability to focus so closely on vaccine development. "They have the proper kind of facilities and the freedom and a mission, and they go for it. That's an excellent thing."

The center has a lot going for it, agreed Kenneth Mayer, MD, professor of medicine and community health at Brown University. It has access to cutting-edge basic science research funded through the NIH intramural program and, unlike private firms that depend on making a profit, its federal funding source allows the center the freedom to pursue innovative research that gives no promise of short-term payoff.

"I think it helps stimulate the field even more than if you just leave vaccine development to the private industry and academic labs outside of the NIH," said Dr. Mayer.

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