( s. Though perhaps controversial such a...)Secret of smallpox's success may lead to bioterror cure

Jacob's current attempt to develop a post-exposure smallpox vaccine is also not with its challenges. Because of the extreme dangerousness of the smallpox virus, the effectiveness of the vaccine cannot actually be tested through clinical trials on humans. Instead, the vaccine is tested on mice and other animal models, using viruses closely related to smallpox that are lethal to those animals.

"We're testing with vaccinia and mousepox in lab mice, and in dormice with monkeypox. These are good model systems ?if we can protect against mousepox in mice, then we have a high level of certainty that the vaccine will be able to protect against smallpox in humans," Jacobs said.

"Since you can't test in people, the FDA's animal efficacy rule applies. If you can show efficacy in several animal models, then you can presume efficacy in humans, if it is for a disease that you can't ethically expose people to in trial. The vaccine will go through safety studies in humans, though."

Because of the importance of the research for national security, Jacob's work is on a fast-track, with the studies projected to yield a usable vaccine virus within eighteen months. At that point, the virus will go to a commercial manufacturer, who will be responsible for developing and then producing a complete nasal-delivery vaccine. If all is successful, a large number of doses will then be produced and put into storage for possible use in case of emergency, in accordance with the procedures of Project Bioshield.

Though the final product may take a while to be produced and, one hopes, may never have to be used, Jacobs has a feeling now of years of research coming to fruition.

"This is the result of work that we have been doing for 15 years now and I think we are really very close to producing some really impo
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Source:Arizona State University