VCU tests H1NI vaccine

VCU Health Systems is currently testing a new vaccine to combat the H1N1 virus. As of Friday morning, VCU had tested the vaccine on 53 children.

“We’re looking at different doses of the vaccine to see what the minimum dose is to produce a good immune system response,” Dr. Linda Meloy said. Meloy is the primary investigator of VCU’s children’s study and a professor of pediatrics. “We don’t want to give anybody any extra viral particles than they need.”

VCU is conducting two different studies of the vaccine; one on children between the ages of 3 and 9, and one on people more than 65 years of age. The trial began Sept. 12 and will run until the vaccine is tested on 1,500 children nationally, Meloy said. VCU is one of 30 sites nationwide that are conducting the study.

The vaccine that VCU is testing was created by Novartis Vaccines and Diagnostics Limited, a Switzerland based company. According to Novartis’ Web site, it is the world’s largest vaccine manufacturer and the second-largest supplier of flu vaccines in the United States.

The Web site went on to state that in Novartis’ first trial of the vaccine there was strong immune response in 80 percent of subjects after one dose, and more than 90 percent after two doses.

Meloy currently gives two shots to the arm, but said that part of what the study is trying to learn is whether only one dose of the shot is sufficient. She said the vaccine was first tested on animals and then on humans in Europe.

Because the vaccine was held two weeks longer than expected by the U.S. Food and Drug Administration, it made it harder for Meloy to test children because of school being back in session.

“Part of our problem was school,” Meloy said. “You can imagine, in this age group, none of the 5 and 6-year-olds want to miss school, and we don’t want them to miss school too.”

To compensate for this, the study has also been testing the vaccine at night and on weekends.

An FDA press release stated that the “H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose.” The FDA also stated the most common side effect to the injection is soreness at the injection site, and that additional side effects may include mild fever, body aches and fatigue.

Meloy said that so far she has yet to see any major reports of side-effects, and that so far all subjects are doing fine.

“We’re giving good care,” Meloy said. “We’re checking their blood levels, there is no placebo. Everyone gets some viral particles, so it’s not a placebo.”