May 7, 2004

New anthrax vaccine in clinical trial at Vanderbilt

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Kathryn Edwards, M.D.

New anthrax vaccine in clinical trial at Vanderbilt

A new vaccine to protect against anthrax infections will undergo clinical trial testing at Vanderbilt University Medical Center and up to 11 other national sites in an effort to determine correct dosing formulas.

The clinical trial is designed to determine the best formulation to induce the most robust immune response.

Anthrax is a disease caused by a naturally occurring bacterium, but it can be deadly and has been used as a weapon of bioterrorism. The current anthrax vaccination, Anthrax Vaccine Adsorbed (AVA), must be given six times over 18 months with yearly booster shots.

The vaccine tested at Vanderbilt is the recombinant protective antigen 102 (rPA102) and is made from a genetically engineered single protein designed to produce a protective antigen involved in the pathogens of anthrax. The vaccine cannot cause anthrax. No one in the trial will be exposed to anthrax.

In a previous phase one trial of rPA102, with 100 participants, no serious side effects were reported.

At least 50 volunteers are needed from the Nashville area. Military personnel or emergency first responders are not eligible to participate. A total of 480 participants will be recruited nationally in an approximate six week time period. Volunteers must be healthy; with no previous exposure to anthrax or the vaccine in the past; they must have no history of a malignancy, immunodeficiency, or autoimmune disease; and no history of chemotherapy within the last five years and not currently be participating in another research study.

Kathryn Edwards, M.D., professor of Pediatrics and vice chair for Pediatric Research in Pediatric Infectious Disease, serves as the principal investigator for the study, funded by the National Institutes of Health by a grant from the makers of the vaccine, VaxGen, Inc.

“We’ll be studying eight different dosing formulations to determine which dosing level would be most beneficial, Edwards said.”

The vaccine, which could be approved by the FDA within a year, showed great promise over the current method of anthrax vaccination. Future trials of the vaccine will test the body’s immune response to AVA versus rPA102, according to Edwards.

“Participants have thus far have shown to have far fewer side effects or reactions,” she explained.

Volunteers who participate could earn up to $600, receiving $50 for each visit to the clinic. There are a total of 14 visits required over the next year, with most of those visits occurring in the first eight weeks of the study. Blood is drawn on all visits but two, and the vaccine is administered on visits two and seven. Volunteers will be compensated for their time and travel.

“You might experience some redness around the vaccination site, and possible muscle soreness at the vaccination site,” explained Debbie Hunter, R.N., who is coordinating the study with Edwards. “There is also the possibility of headache and fatigue, which are generally mild and require no treatment.”

Hunter cautioned that because the study is testing dosing levels, it is unknown if the vaccine will protect against anthrax infection, which is why emergency first responders are excluded from the study.

For more information about the study, contact Hunter at 322-2757.