150 volunteers roll up sleeves for test of avian flu vaccine

April 05, 2005|By Michael Stroh | Michael Stroh,SUN STAFF

It was, in part, the tombstones that drew him.

As he rolled up his sleeve yesterday to receive one of the first doses of a new experimental flu vaccine, Vic Maslanka recalled the cemetery where he mowed grass as a child. Many of the headstones bore the same date: 1918.

His parents later explained the significance. It was the year the Spanish flu arrived and killed tens of millions around the globe. Two of the names on the tombstones, Maslanka discovered, were those of relatives.

So when he heard that the University of Maryland School of Medicine was preparing to test a vaccine designed to stop avian flu - a potential successor to that killer virus of 1918 - Maslanka quickly signed on.

"This was personal," says the 48-year-old Monrovia engineer.

Maslanka is one of 150 adult volunteers taking part in the study at three U.S. sites funded by the National Institutes of Health. The goal: to see whether the new vaccine is safe and, just as important, whether it triggers an immune response.

First isolated from South African terns in 1961, the virus has mostly been a problem for Asian farmers, who each year watch it wipe out millions of chickens and other commercial fowl.

But in 1997, it claimed its first human fatality, a 3-year-old Hong Kong boy. Since then, the toll has grown slowly but steadily. In the past 14 months, the virus has sickened 69 people and killed 46, mostly in Vietnam and Thailand, according to the World Health Organization.

But it's not a death count that has scientists spooked. About 70 percent of people infected with avian flu die from it. The mortality rate for the Spanish flu, by comparison, was less than 3 percent. The fear is that if natural genetic mutations make the virus more capable of being transmitted from person to person, it could ravage the globe.

"Nobody has the crystal ball," says Bruce Gellin, director of the U.S. National Vaccine Program Office. "But this is a virus that shows it's got the ability to be lethal in people."

U.S. officials are taking no chances. On Friday, President Bush signed an executive order adding avian flu to the U.S. quarantine list, which includes cholera, diphtheria, plague, smallpox and yellow fever.

Health agencies also are turning to vaccines to prevent the spread of the virus. Last fall, the government paid $13 million for 2 million doses of a new avian flu vaccine made by Sanofi Pasteur of Swiftwater, Pa.

The new experimental vaccine, scientists say, is nearly identical to the flu shot that millions of people get each year, with one important exception.

The key ingredient in the standard shot is hemagglutinin, a protein jutting from the surface of the influenza virus that allows it to latch onto cells. There are 15 known types of hemagglutinin, designated H1 to H15.

The standard flu shot is a cocktail of three hemagglutinin proteins. The new experimental vaccine will contain one - H5.

"What we don't know is what the strength of those shots should be," says Linda Lambert, who heads the influenza division at the National Institutes of Health. That's the question scientists at Maryland and the other two test sites - the University of Rochester and the University of California, Los Angeles - will try to answer.

The standard flu shot contains 45 micrograms of hemagglutinin. "Could you get away with half as much, do you need three times as much?" says Lambert. "Nobody knows."

To find out, doctors at the test sites will inject volunteers with one of four different concentrations of vaccine or a saltwater placebo. A month later, volunteers will return for a second shot, since people who have never been exposed to influenza typically require two shots to boost antibody production.

During the first phase of the study, expected to last seven months, researchers will draw blood from the volunteers to measure levels of antibodies against the H5 bird-flu protein.

The call for volunteers drew subjects with a variety of motives. For Paul Martin, 30, a lab technician at the Baltimore Veterans Administration Medical Center, it was the offer of $530 cash, which he plans to spend on a surfing trip.

Others felt like Ann Ashby, 58, of St. Michaels, who wanted to do something to help fight avian flu. "It's a vary scary possibility," she said.

Ashby and fellow volunteers know they risk rare but potentially serious side effects from the vaccine, including anaphylaxis, a sudden and severe allergic reaction that can result in death. The reaction occurs in one per million doses, says James Campbell, the pediatric infectious disease specialist overseeing the vaccine trial at Maryland.

After receiving her shot, Ashby was taken across the hall into a waiting room, where she sat for 30 minutes while a nurse watched her for reactions.

Because the avian flu vaccine is made with killed virus, Campbell says, it cannot give someone the disease. But volunteers might experience side effects such as headaches, muscle pains and a slight fever.

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