Testing begins on experimental flu vaccine for children

On one of his last days of summer vacation, Hunter Sears would have preferred to still be in bed at 10 a.m., or maybe just settling in for a few good hours of television.

So why, exactly, was the 13-year-old Anne Arundel County boy sitting in his Annapolis pediatrician's office yesterday, his orange T-shirt rolled up to his shoulder as a nurse first took blood from his arm and then gave him a shot he didn't need to get?

Hunter was pediatric volunteer No.1 of an expected 600 nationwide for an experimental vaccine against the H1N1 influenza virus, a new strain of flu that appeared in April and which officials fear will be widespread come fall. But before a mass vaccination can be rolled out - one that could involve hundreds of millions of inoculations - hundreds of adults and children have volunteered for clinical trials to test the vaccine's safety.

Officials with the University of Maryland, Baltimore, which is running the trials, strongly believe the vaccine is harmless.

"There really is no scientific rationale to believe it is going to be unsafe," said Dr. Wilbur Chen, a flu researcher at the at Maryland's Center for Vaccine Development, who was handling some of the trial paperwork yesterday. "The vaccine is being manufactured in exactly the same way as the seasonal flu vaccine," which is approved for children 6 months and older.

Still, the vaccine is considered experimental, not yet approved by the Food and Drug Administration and could have unknown risks; that's why it is being tested on a small group first.

While being on the cutting edge of something unproven might be frightening for some parents, especially when the trial starts with babies as young as 6 months old, many have lined up to put their kids' arms out to further science. Besides, some said, if there's a shortage of vaccine coupled with a severe swine flu outbreak, they won't have to worry. Their children will already be protected - and they won't have to miss school and sports.

"If it works, then we have a leg up," said Kate Houley, an Annapolis mother who signed up her three boys - ages 7, 10 and 11 - for the trial. "If it doesn't, it doesn't. And these guys don't really mind shots."

Researchers have only had difficulty recruiting one group of children: those ages 6 months to 3 years; about 20 are needed locally. Some parents might be more reluctant to give babies and toddlers an unproven vaccine, researchers said. And parents of such young children might already be overburdened with doctors' appointments, and unwilling to participate in a trial that would require an extra three (as well as taking the child's temperature daily).

A total of 600 children will be enrolled by Maryland and five other sites around the country to test the pediatric vaccine. For years, little medical research was done on children due to worries about what might happen to them. But this put them at a disadvantage, as doctors were left without guidance as to how much of a certain medication, for example, a sick child should receive.

Dr. Holly Taylor, who is on the faculty at the Johns Hopkins Berman Institute of Bioethics, said many factors have to be considered when determining whether something should be tested on children, but the risk to the child should be as small as possible, and there should be a benefit to the child and to children at-large.

"We're always more careful when we conduct research with children," she said. "We learned a long time ago that kids are not mini-adults and might have different kinds of responses" to medications or vaccines than adults.

On Tuesday, the National Institute of Allergy and Infectious Diseases said it had reviewed enough data from adult trials of the H1N1 vaccine that began two weeks ago to determine there were "no safety concerns in those trials that would preclude trials from proceeding in children."

The children being tested in Maryland will receive vaccines at three sites: pediatric practices in Annapolis, Frederick and at the University of Maryland, Baltimore. They will get either 15 or 30 micrograms per shot and two doses spaced three weeks apart. Older children will have their blood drawn over five separate visits. For their trouble, the children will receive $40 Target gift cards at each visit - not a small carrot, several said.

"The purpose of these tests, yes, are to assess whether there are any safety issues or reactions to these vaccinations," Chen said. "Our real scientific question is what are the best doses of vaccine to use for these vaccines because we have a limited supply and the government wants to know how to use this best come October."

Officials had planned to have 120 million doses available in October, but factory problems have cut that estimate to 45 million doses. Chen expects to start a trial next month that would add a substance called an adjuvant to the vaccine, which is designed to boost the effectiveness of the inoculation. That could mean smaller doses of vaccine would be needed for each person and more people could ultimately be vaccinated. But the adjuvant has not been approved for use in the United States as it has been in Europe and Chen worries it could be controversial.

In the exam room, with 11-year-old Ethan waiting for his shot, Houley said even though the H1N1 vaccine is technically experimental, she doesn't see it that way. "It's not like if you have cancer or something and you're going through an experimental drug trial - that's experimental," she said. "This is a flu vaccine. I didn't think about it ... as a huge risk. If I did, I wouldn't be here with my kids."

Hunter Sears was there because of his grandmother, Gladys Sears, who has worked at Annapolis Pediatrics for 46 years. In 1976, when there was a different swine flu outbreak, she got vaccinated. The next day, the government canceled the vaccination campaign, in part because it appeared to be making some people sick. That didn't color her opinion of whether her grandson should enroll in the study.

"After years of working here, I don't worry about things like that," she said. "Some people have to be guinea pigs."

Research nurse Linda Wadsworth, who gave the H1N1 vaccine to adult subjects last week, had new concerns with the kids. Would they cry? More importantly, which bandages did they want: multicolored, animal print or Nemo?

Hunter, with his sandy mop-top practically covering his eyes, looked away as nurse Tamekah Godfrey slipped the needle into his bicep. He didn't react when she was done.

After a bit, he asked: "You already put it in?"

"Yeah," answered another nurse, Kathy Cantrell. "You did great."