March 26, 2003

Wanted: Volunteers for Anthrax Vaccine - Should You Roll Up Your Sleeve?

The Wall Street Journal
By Greg Bluestein

Government Offers Injections To Civilians via Clinical Trials;
WORRIED ABOUT ANOTHER round of anthrax letters if terrorists strike again?

The more than 200,000 troops in the Persian Gulf don't need to worry about getting a vaccine to fend off the deadly bacteria. They and other high-risk people, from Centers for Disease Control and Prevention officials to some veterinarians, can receive injections administered in an six-shot sequence over a year and a half, plus regular boosters.

But there is an option for the rest of us. In a government-sponsored clinical trial, five major hospitals around the country are recruiting civilian volunteers for a test of the vaccine. The goal is to figure out how many shots are required, and where they should be administered in the arm, in order for the vaccine to be more effective.

Yet curiously, even as the war against Iraq heightens the threat of a biological attack, recruiters are struggling to find enough volunteers to roll up their sleeves. "I'll be honest with you. I thought after putting our ads out, we'd be swarmed," says Col. Janiine Babcock, a lead investigator at the Army's Walter Reed Institute of Research in Silver Spring, Md. Her hospital, along with Emory University, the University of Alabama-Birmingham, the Mayo Clinic and Baylor College of Medicine, is rounding up a total of 1,560 volunteers for the 43-month study.

Researchers are looking for people age 18 to 61 years old, in good health.
Volunteers must be willing to receive six injections of the vaccine over a period of 18 months, followed by two years of clinical visits and booster shots. Depending on which clinic administers the shots, participants can be paid up to $2,000.

Some are volunteering for the money, while others hope to get protection from the potentially deadly disease. Others are doing it as a show of patriotism.

"The men and women over there are doing a lot for us and it seemed to be a minimal thing that we could help them with," says Kay Vydareny, who is participating in the trial. Her son is in the U.S. Army in the Persian Gulf region.

Without vaccination or powerful antibiotics, anthrax can be fatal after entering the body's respiratory system, infecting lymph tissues in the chest with toxins that attack cells. But the only way for the general public to get protection is to take part in the clinical trial.

One possible deterrent to signing up: Participants aren't guaranteed that
they'll get protection from the deadly bacteria. One-sixth of them will be
given a saltwater placebo, while others will be given different doses to determine if fewer than eight injections are adequate. Some shots will be given in muscle as opposed to under the skin to see if the typical side effects of redness or irritation are lessened.

So who would be willing to weather multiple injections, keep a diary, have blood regularly drawn, meet with doctors for 26 study visits, and possibly suffer from side effects like soreness, itching, redness and swelling, among others?

While the health risks for volunteers are minimal, the final decision may boil down to how concerned you are of an anthrax attack. Says 47-year-old Angel Candelario, minutes after his third injection, "You have no idea what a good feeling I have. It gives me a little relief, a lot of confidence, that something's in my body, just in case. Even if I just got the placebo."

Scientists insist the risks are minimal. Among the side effects: pain, swelling and, less frequently, headaches and more severe reactions. Brad Perkins, CDC's principal investigator of the anthrax trial, says these possibilities are "very much in line" with other vaccines routinely given to adults. Col. Babcock says trial volunteers have suffered no serious reactions so far.

The anthrax vaccine test actually predates the fatal anthrax mailings of the fall of 2001, just after the Sept. 11 terrorist attacks on the U.S. In 1999, Congress provided $20 million for the CDC to oversee trials designed to improve the existing vaccine, AVA, which the Food and Drug Administration approved 33 years ago.

Research on AVA gained momentum after the deadly 2001 attacks, for which no suspect has been implicated. That string of mailings killed five people from Florida to New England, sickened more than a dozen others, and panicked Americans nationwide. While anthrax spores don't spread easily through air -- health officials worry more about contagious viruses such as smallpox -- government officials do fear that terrorists are stockpiling the bacteria.

Since 1998, more than 800,000 soldiers have received the vaccinations, as have other at-risk Americans. After the 2001 mailings, 10,000 congressional staffers and mailroom workers were offered the vaccine, but fewer than 100 chose to receive them -- a harbinger, perhaps, of the dearth of volunteers for the current study.

Yet for 23-year-old Sami Hamed, whose daily duties include opening mail for Rep. Raul Grijalva, a Texas Democrat, joining the trial made sense. "It didn't bug me too much, but with all these news stories of anthrax here and there, you can never be too safe," he says.

Col. Babcock expects to reach full capacity at her clinic in two months; nationwide, researchers still hope to sign up 400 more participants by July. But it has been tough going finding enough volunteers lately. Plastering a few bulletin boards with ads is usually enough for most studies, she says, but she has already spent $75,000 -- more than double the allotted budget -- for ads in places such as the Washington Post and Roll Call, a periodical read by congressional staffers and lobbyists on Capitol Hill.

For now, the AVA vaccine is the only option. The biotech company Human Genome Sciences Inc. says it has developed a potentially more effective drug called ABthrax that could protect against and treat exposure to anthrax, but it is still in development.