Children offered $40 for swine flu clinical trial

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FYIhttp://www.cnn.com/2009/HEALTH/08/20/h1n1.flu.kids.trial/index.html

Kids roll up sleeves for H1N1 clinical trialStory HighlightsNational Institutes of Health has specific H1N1 vaccine trials for children

People 6 months to 24 years at high risk of developing H1N1 complications

Studies compare H1N1 and seasonal shots, look at dosage

Doctor: Data gathered will be crucial for proving vaccine safe for kids

By Val Willingham

CNN Medical producerFREDERICK, Maryland (CNN)

-- Andrew Stein, 10, and his brother, Nathan, 7, are having a typical

end-of-summer vacation: hanging out at the pool, visiting their

grandparents and waiting for the beginning of school.But this

week they're doing something most of their classmates will never do.

The Stein brothers will be testing the new vaccine to prevent swine flu.Because

the younger population, from 6 months to 24 years, is at high risk of

developing complications from the H1N1 virus, the National Institutes

of Health is conducting a clinical trial specifically to make sure the

vaccine is safe for children. Vaccine developers hope to get the doses

out by mid-October, before the flu season really shifts into high gear.Although

both boys dislike needles, they are willing to make the sacrifice. "One

boy that I knew at our school died from a type of the flu," said

Andrew, frowning. "So I wanted to prevent that as much as I could."The

boys, who live in the suburbs between Baltimore, Maryland, and

Washington, got their first inoculations at the vaccine satellite

office in Frederick, Maryland. The trial is being conducted by the

University of Maryland School of Medicine, one of 11 institutions

across the country holding pediatric trials. Researchers will test the

boys' blood, have them keep journals and make sure they have no severe

reactions after each vaccine.The pediatric studies are divided

into two groups within the United States. Half the sites will be

comparing reactions between the H1N1

shot and the seasonal influenza vaccines on kids; the others will be

looking at the effectiveness of a two-dose vaccine. The Steins are

enrolled in the dosage trial.The data are crucial for developing

a safe vaccine, said Dr. Karen Kotloff, who heads both the pediatric

and adult trials at Maryland. "The purpose of the studies we are doing

is to try to collect information that will help to inform policymakers

about the best way to give the pandemic H1N1 flu vaccine," she said.

"Whether we need one or two doses and what strength we need."Before

they received their shots, both boys, along with their parents, Christy

and Eric Stein, got an explanation of the procedure and were warned

about possible complications. Nancy Wymer, who coordinates the study,

says the boys will receive two inoculations over six weeks and will

continue to check in periodically over the following six months.Dr. Sanjay Gupta reports on the H1N1 clinical trial »Neither

brother gave more than a grimace as he rolled up his sleeve and took a

shot for science. Andrew Stein said it was no big deal. "It was in and

out, in a couple of seconds."Why would parents have their

children be part of such a trial? Most say to help other children.

Christy Stein was involved in a pediatric trial for the swine flu

vaccine in 1976 and understands what her sons are going through. But

she also believes it's good for the country's public health. "I trust

the people who are running the study," she said. "And I'm not concerned

about it at all."The studies are based on other influenza trials

in the past. Many parents have already volunteered their children but

openings still exist. Children 6 months to 35 months are needed,

Kotloff said. "Like with any shot, children may have a sore arm. Your

arm can be red...There might be some fever or achiness, but the

symptoms go away in a couple of days."There can be allergic

reactions, mostly rashes, but in some rare circumstances there can be

severe allergic reactions," she added. "Each volunteer is informed

about these possibilities, so it's up to the parents to make that

choice."The 11 main sites across the U.S, in nine states, are currently recruiting children for the vaccine trials. The two-dose vaccine tests

are being conducted at the University of Maryland Baltimore; Duke

University in Durham, North Carolina; Children's Mercy Hospital in

Kansas City, Missouri; Children's Hospital and Regional Medical Center

in Seattle, Washington; and Vanderbilt University in Nashville,

Tennessee.And the trial comparing H1N1 and seasonal flu vaccines

is at Hope Clinic, Emory University in Atlanta, Georgia; St. Louis

University in Missouri; the University of Iowa in Iowa City; Cincinnati

Children's Hospital Medical Center in Cincinnati, Ohio; Baylor College

of Medicine in Houston, Texas; and the University of Texas Medical

Branch in Galveston.Each location has a Web site to sign up if more children are needed.Andrew

and Nathan are doing fine. They will keep a diary on how they feel and

what, if any, reactions they have. Each was rewarded with a $40 gift

card for his trouble. And even after being stuck with a couple of

needles, Nathan Stein says it was worth it."Not just for the gift card," he said, "but for being able to help other kids."All AboutSwine Flu