anthrax_03A0113

OSU Will Use Non-Human Primates to Test Anthrax Vaccine

OSU received $103,330 from Vical, a company working on a new safer and more effective vaccine against Anthrax, October 2003 and the protocol to use 60 rhesus monkeys has been approved by the ILACUC, 2003A0113 Vaccine Research.

Some background from Wired News - for the entire article click on the link.
A Step Closer for Anthrax Vaccine
By Kristen Philipkoski
Story location: http://www.wired.com/news/technology/0,1282,57971,00.html

An alternative to the only approved vaccine for anthrax is one step closer to being tested on humans after successfully protecting rabbits from the effects of the bioterror agent.

Unlike most vaccines, which are a modified version of the infectious agent, the new vaccine is made of DNA. It's being developed by Vical, a vaccine producer in San Diego.

Government personnel are currently vaccinated with a product made by Bioport, which has generated controversy over whether it's safe and effective. Vical hopes its vaccine will progress speedily through the FDA approval process because of the possibility that it might be safer, cheaper and more effective.

"Our vaccine is a beautiful vaccine because it does not use a pathogen at all," said Vijay Samant, Vical's president and CEO.

Instead of the pathogen in question (in this case, anthrax), Vical's vaccine contains the gene sequence that produces certain proteins found in the infectious agent. ---------------

Because researchers can't ethically infect humans with anthrax to test a vaccine, they have to rely on animal studies, for which the FDA has instituted a "two-animal rule."

The rule requires that the vaccine be proven effective and safe in tests on two animal species before being used on humans. Vical has seen positive results from tests of its vaccine on rabbits and mice. -------------

No DNA vaccines have yet been approved by the FDA, and Vical's could be the first. It would also be the first vaccine approved using the two-animal rule.

DNA vaccines take an opposite approach to developing immunity in recipients than do regular vaccines. Whereas conventional vaccines contain the largest amount of a pathogen possible without making a person sick, DNA vaccines contain DNA sequences that produce the smallest amount of proteins from a pathogen that are required to instigate an immune reaction.

Vical's anthrax vaccine contains DNA that produces two proteins found in anthrax.

"That creates a tremendous logistical burden on the military to keep track of who's got the vaccine and when," said Raymond Zilinskas, director of the chemical and biological weapons nonproliferation program at the Monterey Institute of International Studies. "So if you can cut that down to two or three doses, that would save an enormous amount of money."

Vical hopes to make the process less onerous by reducing the dosage to just two injections.

But Zilinskas was concerned that if the FDA approves the vaccine under the two-animal rule, the vaccine would be tested on rabbits and mice but not primates, which are more similar biologically to humans.

Well it looks as like three animals will be used to test the vaccine. Battelle is also involved with this project and from past experiments will probably supply OSU with the non-human primates.