New anthrax vaccine in clinical trial at Vanderbilt

by Jerry Jones

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

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.