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Army Starts Clinical Testing of Ricin Vaccine

The U.S. Army Medical Research Institute of Infectious Diseases on Wednesday announced the beginning of a clinical evaluation of a potential vaccine against the biological agent ricin (see GSN, April 16, 2010).

The Phase 1 trial is intended to examine the safety of the ricin vaccine candidate and its capacity to produce an immune reaction from a limited pool of participants. Depending on the results of the Phase 1 trial, further testing could be conducted on an expanded number of people.

Two individuals have received the vaccine so far this month. Both study volunteers are doing fine, according to USAMRIID Clinical Research Department researchers.

There is presently no cure for exposure to ricin, a toxin derived from castor beans that can be deadly in very small doses. The commercial prevalence of castor beans around the world has increased biodefense experts' fears that ricin might become a tool of terrorism.

Following inhalation, ricin particles cause very strong respiratory problems that result in lung failure within three days. Ricin, if consumed, can produce strong gastrointestinal problems that result in "vascular collapse and death," according to a USAMRIID press release.

The Army institute has spent years seeking to create a ricin vaccine. This study is a key point in that program, according to senior research scientist Leonard Smith.

"In the recent past, [U.S. Defense Department] acquisition strategy involved USAMRIID's developing medical products to a specified maturity and then handing them off to another agency for advanced development," Smith said in provided remarks. "Now we have been able to do the initial production of the vaccine ... as well as the Phase 1 clinical trials, right here at USAMRIID. This early product evaluation in-house saves both time and money."

Previous testing demonstrated that the ricin vaccine candidate provided mice with comprehensive protection against deadly levels of aerosolized ricin. Additional studies were carried out using rabbits and primates, building up to the current Phase 1 testing on humans, Smith said.

The U.S. Food and Drug Administration has approved the vaccine candidate for investigational testing. In all, 30 participants would receive three vaccine doses in a roughly two-month time line (U.S. Army Medical Research Institute of Infectious Diseases release, April 13).

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