Vaccine Reduces Ear Infections, Czech Researchers Say

But more proof is needed that the inoculation works, a U.S. expert adds

FRIDAY, March 3, 2006 (HealthDay News) -- Czech researchers are reporting a successful trial of a vaccine for acute otitis media, the inner ear condition that is the most common bacterial infection in children.

The incidence of ear problems among young children given the vaccine was a third lower than for those who didn't receive it, said doctors at the University of Defence in Prague.

The vaccine contains proteins from 11 different strains of the bacterium Streptococcus pneumoniae that are also attached to a protein derived from another infectious agent, Haemophilus influenzae. The vaccine thus protects against the two main causes of middle ear infection, the report said.

The study included nearly 4,700 infants ages 3 to 15 months who were followed until the end of the second year of life. Half got the vaccine and half were given a hepatitis A vaccine to serve as a control group.

The researchers said there were 333 cases of acute otitis media in the group that received the ear infection vaccine vs. 499 in the control group.

The findings appear in the March 4 issue of The Lancet.

The vaccine "is currently being tested in ongoing Phase 3 clinical trials," according to a statement by drug maker GlaxoSmithKline, which plans to market the shot as Streptorix. Phase 3 trials include the final set of tests needed to seek approval for marketing a pharmaceutical product.

"It is the company's intention to file regulatory applications in 2007 in Europe," the statement said. "We are in discussions with FDA [the U.S. Food and Drug Administration] to determine a timeline for filing a biologics license application in the United States."

The study results are "very exciting" but still preliminary, said Dr. Allan S. Lieberthal, a pediatrician at Kaiser Permanente in California and co-chairman of the American Academy of Pediatrics' and American Academy of Family Physicians' subcommittee on the management of acute otitis media.

Lieberthal said he was cautious because of the criteria used in the study to define acute otitis media. He was a member of the committee that drew up criteria to distinguish the ear infection from a condition called otitis media with effusion, which is accumulation of fluid in the middle ear caused by a temporary blockage and usually clears up by itself. Acute otitis media, by contrast, often requires antibiotic treatment, with an estimated five million such prescriptions written in the United States each year.

While the committee criteria required onset of symptoms within 48 hours, the Czech study accepted cases diagnosed as late as 14 days afterward, Lieberthal said. In addition, the study did not require signs of inflammation, another criterion set by the committee.

"If this is reproduced in other studies and the vaccine is safe, it would suggest that the vaccine would decrease infection by those bacteria and possibly result in a reduction of acute otitis media," Lieberthal said. "But before you say 'this is an acute otitis media vaccine,' you have to do studies using a better definition of acute otitis media."

Still, Lieberthal's caution was coupled with enthusiasm. The trial results "strongly suggest" that the vaccine protects against infection, and "I think it is a very important vaccine," he said.

More information

To learn more about otitis media, visit the U.S. National Library of Medicine.

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