August 21, 2009

Study set to test pediatric H1N1 influenza vaccine

Study set to test pediatric H1N1 influenza vaccine

When the first Vanderbilt Vaccine Research Program (VVRP) adult H1N1 vaccine trial wrapped up enrollment this week, a pediatric study was given the go-ahead to begin.

Recruitment for the pediatric H1N1 influenza vaccine trials at Vanderbilt has been progressing well since it was announced two weeks ago. More than 100 parents contacted the VVRP within the first week to inquire about the trial and many of them have signed up their children.

“Parents have been asking questions such as the ages of children who are eligible, whether children with stable but chronic medical conditions can be enrolled, how many shots are needed and how many blood samples will be collected,” said Kathryn Edwards, M.D., professor of Pediatrics and director of the VVRP.

The research will be conducted by three members of the Division of Pediatric Infectious Diseases at Vanderbilt: Edwards, Buddy Creech, M.D., M.P.H., assistant professor, and Natasha Halasa, M.D., M.P.H., assistant professor, and Todd Callahan, M.D., M.P.H., assistant professor of Adolescent Medicine. The goal is to enroll 120 children divided equally into three age groups; six months to 3 years, 3 to 9 years, and 9 to 17 years.

All children participating will receive the two H1N1 vaccine doses separated by three weeks.

Half will receive the usual dose usually given to older children each year (15 micrograms) and the other half will receive a larger dose (30 micrograms). Children 10 and older will be asked to provide five blood samples over the course of the six-week study while younger children will be asked for three samples. Subjects will be paid for their participation.

To help accommodate school and work schedules, the team will be available in the evening.

The study will evaluate the safety and immune responses to the two different vaccine doses. The information will be important to determine which dose children should receive when the vaccine becomes available to the general population in October.

“The novel swine H1N1 virus is circulating right now in Nashville, with a few cases reported each week. We expect that when the cold weather comes around and when schools are in full swing, that the cases will increase,” Edwards said.

For more information, call 322-2730 or send an e-mail with “pediatric H1N1” in the subject line to