Children- Vaccine Trial

Old Vaccine Trial

3,000 Children (4-18 years old)

Johns Hopkins

WebMD Health News

May 15, 2000 (Boston) -- It's tick season, and that nasty little bug is out to get your kids. But researchers announced some encouraging news Monday in the fight against Lyme disease. For the first time, a vaccine has been shown to be safe and effective in protecting children 4-18 years of age from Lyme disease, a serious bacterial infection that may cause lifelong arthritis and a certain type of heart disease known as carditis.

This encouraging news was presented here at a joint meeting of the Pediatric Academic Societies and The American Academy of Pediatrics.

The disease, discovered in 1975, is caused by bites from deer ticks found mainly in the Northeast, Midwest, and coastal regions of the U.S., particularly in grassy or wooded areas.

Although anyone living in areas populated by deer ticks is susceptible to Lyme disease, vaccines have only been tested and approved for use in persons over age 15.

Called LYMErix, the agent may soon be administered by injection in the doctor's office to children 4 years of age and older. If approved by the FDA, the vaccine could protect thousands of young children whose only safeguards right now are insect repellent and protective measures.

Neal A. Halsey, MD, from Johns Hopkins School of Public Health in Baltimore, and colleagues administered three doses of the Lyme disease vaccine to more than 3,000 study participants (4-18 years of age) but found that just two doses offered effective protection.

Halsey and his team found only short-lived, minor side effects with the vaccine, including fever, fatigue, headache, and joint pain.

Ram Yogev, MD, tells WebMD that two doses is all children need to be protected. "We would save a lot of money and pain for the kids with two [doses] -- two would be effective," says Yogev, who is professor of pediatrics at Children's Memorial Hospital in Chicago.

In 1999, more than 1 million doses of LYMErix were distributed to persons ages 15-70 with no adverse side effects. The FDA will review the Lyme disease vaccine and the results of this study over the next several months to determine if the vaccine will be approved for use in children 4 years of age and older.

If it is approved for this population, Yogev says that awareness about who needs it and who doesn't will be essential. "It's a good vaccine, but it's not for everyone," he says. "Physicians and consumers need to be taught that there are certain states where it's important."

In the meantime -- with tick season in full force during the months of May, June, and July -- the CDC recommends parents take precautions to reduce the chances of their children being bitten by a tick. Avoid tick-infested areas; wear light-colored clothing; tuck pant legs into socks or boots; spray insect repellent containing DEET on clothes and exposed skin, avoiding the face; and walk in the center of trails to avoid overhanging grass and brush.

Lyme disease in early stages is usually marked by one or more of the following signs: fatigue, chills and fever, headache, muscle and joint pain, and a characteristic skin rash, apparent by its "bulls-eye" design.

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