Harbor-UCLA unit will test anthrax vaccine VaxGen hopes for contract with nation's bioterrorism protection program.

By Lee Peterson
Daily Breeze
October 31st, 2004

A local vaccine research center is testing a new-generation anthrax vaccine hoped to be safer and easier to use than a version the U.S. military has been ordered to stop forcing on its troops.

Ten to 12 sites around the United States are testing the dosage requirements and safety of an experimental anthrax vaccine made by VaxGen, a Brisbane, Calif., company that hopes to sign a deal this week to provide 75 million doses to the federal government for its bioterrorism protection program. The doses would be given to civilians, if needed.

Anthrax attacks in the mail in the fall of 2001 killed five people and made at least 17 others ill.

VaxGen is waiting to hear about the contract to supply the government with the vaccine. The company last year received an $80 million grant from the National Institute of Allergy and Infectious Diseases to develop the new anthrax vaccine. VaxGen has received more than $100 million in grants to work on the vaccine.

One of the study sites working with VaxGen is the UCLA Center for Vaccine Research, at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center near Torrance. Of the roughly 500 subjects in the clinical trial nationally, 45 local residents are participating.

A federal judge last week ruled that the Defense Department must stop its mandatory vaccination program because the Food and Drug Administration improperly approved the vaccine made by BioPort for general use, The Washington Post reported.

While BioPort has defended its vaccine as safe and effective, some service members have refused the vaccine, which is given in a series of six injections over 18 months, and produces immunity to the anthrax bacteria.

It's hoped that the VaxGen version can be given in only three injections. The trial that LA Biomed is participating in involves testing the response to two doses.

Susan Partridge, associate director of the UCLA Vaccine Research Center, said the trial started locally in May, and there were no problems signing up the 45 healthy subjects. If there are more local residents who are interested, she said the center anticipates conducting additional clinical trials with the same vaccine, starting in spring 2005.

The VaxGen version is known as a "recombinant protective antigen," and is supposed to be less prone to side effects because it is made from a single, purified protein, its makers have said. It's hoped that the new vaccine could be used both as a preventive measure given before any exposure to anthrax, and as a post-exposure treatment.

"It's a national priority to develop a safer and easier-to-administer anthrax vaccine both for the military and the general public," said Dr. Joel Ward, director of the UCLA Vaccine Research Center. So far, he said the center has seen no untoward effects in local subjects who have been vaccinated.