Colorado kids in flu trial
A group of Colorado children will be among the first in the world to test a swine-flu vaccine as part of a global effort to mass produce an immunization by mid-October.
A Denver physician is beginning a clinical trial this week for Novartis, one of several drug manufacturers racing to make a vaccine for the H1N1 virus.
The world’s leading producers of the seasonal flu vaccine — changed yearly to target the most threatening strains — are using the same technology to create an H1N1 immunization. The seasonal flu vaccine, in the making since late winter, will not protect against swine flu.
About 100 Colorado children ages 3 to 8 are expected to participate in a clinical trial led by Denver immunologist Dr. Isaac Melamed of IMMUNOe 1st International Research Centers in Thornton.
Melamed said he thinks he will find enough children for the study within a few days, given that many parents are eager to have their children protected from the virus. Because the vaccine was developed in the same way as the seasonal flu shot, medical experts foresee no problems.
The research center canceled other projects for the next month to focus on H1N1.
The Denver study is part of a larger clinical trial at about 30 sites in the United States and Mexico. A handful of other drug companies under contract with the federal government also have set up trials, using the “seed virus” from the Centers for Disease Control and Prevention in Atlanta.
The federal government has ordered 195 million doses, about 45 million of which are expected to be ready in October. It could take until late November before a significant number of people are protected against the virus, though.
That is because people will need two shots about three weeks apart. It will take up to two weeks after the second shot for immunity to take effect, health officials said.
“Everybody’s expectation is the vaccine will be safe,” said Dr. Matthew F. Daley, a professor at the University of Colorado Denver and pediatrician at Children’s Hospital.
Vaccine technology is much safer today than it was in 1976, when a government immunization program against swine flu was linked to neurological side effects, he said.
“The technology is much more refined — only what needs to be in the vaccine is in the vaccine,” Daley said. “It’s a little like comparing the safety of cars in 2009, with air bags and everything, to the safety of cars in the ’70s.”
Swine-flu cases in Colorado have resulted in 62 hospitalizations and one death, according to the state health department. The virus was first confirmed in the state in April.
Public-health departments across the state are making plans to distribute the vaccine at schools and health fairs to those who the CDC determines are most susceptible to the virus, mainly pregnant women and people between the ages of 6 months and 24 years.
The virus was responsible for 28 flu outbreaks at summer camps in Colorado, and as schools opened last month, health officials were asking parents to keep sick kids at home. About 50 college students in Boulder have tested “probable” for the flu.
About 209,500 people worldwide have caught swine flu and at least have 2,185 died from it, according to the World Health Organization.
The vaccination part of the study is likely to last only a couple of days, Melamed said. Doctors will follow up with the children throughout the next year. Families who participate are not paid but can receive compensation for time and travel.
By Jennifer Brown
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