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Biosafety lab advances H1N1 vaccine testing

Unbeknownst to many, nestled on the edge of Duke’s Medical Campus is a high-security lab that houses numerous contagious viruses.

The Regional Biocontainment Laboratory on LaSalle Street near Erwin Road was the first of 13 of its kind in the country. It focuses on medical countermeasures—vaccines, drugs and diagnostics—in response to biological threats. The RBL ranks at Biosafety Level 3 on a scale of 4, meaning that it can handle hazardous microbes. The lab houses research animals and deals with airborne microbes, including influenza, tuberculosis, the plague and the West Nile virus.

The National Institute of Allergy and Infectious Diseases, an organization that is part of the National Institutes of Health, funded the lab’s construction in December 2006. Since then, the lab has conducted research for the NIH in accordance with objectives outlined by the NIAID Biodefense Network, a system that supports the research and development of vaccines against pathogens.

With the recent outbreak of swine flu, RBL’s influenza sector found that only one dose of the vaccine is necessary to protect people from the H1N1 virus. In addition, the scientific community has accepted the lab’s publication detailing the virus’ behavior in animals and prevention strategies after exposure to the virus, said Dr. Richard Frothingham, RBL director.

Elizabeth Ramsburg, a faculty member of the Laboratory of Vaccine Vector Immunology, said the lab also aims to improve the effectiveness of existing vaccines.

“We are involved in one project that directly addresses the novel H1N1 virus, the goal of which is to develop rapid diagnostics that would determine who is sick, before they get sick,” Ramsburg said.

But the RBL does not have a direct role in manufacturing the vaccine. The World Health Organization determines the appropriate strains to make vaccines for, Ramsburg said. She calls the RBL a “basic research lab” that looks into how well the H1N1 vaccine functions.

Part of what makes the lab unique is its size, Frothingham said.

There are eight BSL3 laboratories equipped with high-tech equipment such as two BSL3 aerosol exposure chambers for whole-body or nose-only experiments.

Frothingham said the lab is equipped with “state-of-the-art controls” that go beyond the usual standards. For example, the lab not only directly exhausts air out of the building without recirculation, but also filters the air with High Efficiency Particulate Air filters. Lab workers wear protective gear such as Tyvek suits, which are full-body plastic suits with masks and personal respirators. In addition, each individual experiment is conducted in a separate, sealed room.

All researchers must go through a rigorous safety training program before working in high containment areas, Director of Operations Scott Alderman wrote in an e-mail. Researchers must learn about numerous safety measures such as donning and doffing personal protective equipment, safety cabinet operation, proper handling of sharp objects and proper response to emergency situations.

The lab floor is made of seamless epoxy, and the walls are painted with the same material so that the surfaces remain sealed. In addition to the epoxy, the lab structure also uses stainless steel to make the facilities easier to clean.

Unlike the movie “Airborne,” large masked suits are not needed to enter the general lab to protect from contamination—just plain blue booties—as the RBL is extremely sanitary, Alderman said.

“There is a misconception by some that as soon as you walk into a BSL3 laboratory, you are immediately exposed to infectious microbes,” he said. “This is simply not the case. I would argue that the bench tops, floors and ceilings in the RBL’s BSL3 laboratories are some of the cleanest surfaces on Duke’s campus.”

The lab’s animals are also insulated from possible infections. They are kept in carefully sealed cages—separate from humans and each other—and their air supply is cleaned by HEPA filters.

The lab does not specifically deal with the possibility of bioterrorism, but aims to improve human health, Frothingham said.

But Alderman noted that the RBL does, in fact, handle research related to biological threats.

“It was built to support research activities necessary for the development of better drugs, diagnostics and vaccines to protect the general population from emerging infectious diseases and biological threats,” Alderman said.

The lab, however, may have been inspired by issues surrounding bioterrorism.

Tommy Thompson, then NIH Health and Human Services Secretary, announced in 2003 that the NIH would provide $350 million worth of grants for the next five years to establish eight Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research across the United States. These multidisciplinary centers were considered a key element in HHS’s strategic plan for biodefense research.

“We have moved with unprecedented speed and determination to prepare for a bioterror attack or any other public health crisis since the terrorist attacks of 2001,” Thompson said in a statement Sept. 4, 2003. “These new grants add to this effort and will not only better prepare us for a bioterrorism attack, but will also enhance our ability to deal with any public health crisis, such as SARS and West Nile virus.”

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