Baylor Awarded $3 Million for Nasal Spray Flu Vaccine Study in Texas

A nasal spray influenza vaccine will be given to 15,000 children in Temple, Texas, to test whether this approach can reduce flu throughout a community.

With a $3 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), researchers at Baylor College of Medicine, Scott and White Hospital and Clinic in Temple, and the Texas Department of Health hope to determine whether vaccinating preschool- and school-age children with the nasal spray can also help protect adults from the flu.

"School kids are the most likely to spread influenza, so they are the most strategic group for immunization," says Dr. W. Paul Glezen, epidemiologist at Baylor's Influenza Research Center and principal investigator for the study, which begins Aug. 17.

"If the nasal spray flu vaccine is effective in our study participants, they will be less likely to spread influenza to their parents, which means fewer adults should be exposed to flu viruses," Dr. Glezen says.

FluMist' was submitted for approval to the Food and Drug Administration in June. In a study of 1,602 children conducted at Baylor and Houston-area Kelsey-Seybold clinics and nine other U.S. sites, the vaccine was highly effective at preventing not just the flu but also ear infections. According to a study published in the May 14 New England Journal of Medicine, the nasal spray flu vaccine provided 93 percent protection against the flu and 98 percent protection against influenza-associated otitis media, an ear infection.

"Since the vaccine is a fine mist that is sprayed into the nostrils, many children who fear the pain of a shot might be more inclined to get vaccinated this way," says Dr. Pedro A. Piedra, a Baylor pediatrician who co-authored the New England Journal of Medicine paper. He is a co-principal investigator for the Baylor research in Temple, expected to be the largest study of its kind.

For each of the next three years, approximately 15,000 healthy children between the ages of 18 months and 18 years will be enrolled in the study at the Scott and White Hospital and Clinic in Temple. All participants will receive FluMist'.

Throughout flu season, which usually lasts from November through March, researchers will keep track of health care visits at participating clinics in the Temple area. They will compare the number of flu-related clinic visits with the number in Austin, Texas, a city of comparable size, where the nasal spray flu vaccine is not available.

FluMist' was developed by Aviron, a biotechnology company in Mountain View, Calif., in a cooperative research agreement with the National Institutes of Health's NIAID.

Influenza affects as many as 50 million people a year in the United States. Most children have had the flu two or three times by the age of 5. Each year, more than 20,000 people, most of them elderly, die from influenza and its complications. Yearly flu-related medical costs are estimated to exceed $4 billion.

- GEORGE KOVACIK

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©2006 Texas Medical Center

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