Rockwood Clinic PS, of Spokane, is participating in a clinical study of a vaccine for the H1N1 flu virus, commonly referred to as swine flu, to determine what dose would allow the maximum number of American children to be treated most effectively to combat the H1N1 virus in the coming flu season.
The study, being conducted by a pharmaceutical company that is making the vaccine, is focused on pediatric patients, says Stefan Shipman, an operations specialist at Rockwood Clinic. The vaccine is one of about a half-dozen vaccines being produced by different companies in preparation for the coming flu season, he says.
Shipman says the company that made the vaccine Rockwood is testing, which he declined to name before Rockwood is listed officially as a clinical site for the trial, is seeking to determine whether one dose or two of the vaccine would provide the most effective protection against the virus for patients.
All of the about 40 patients Rockwood expects to enroll in the study will receive two doses of the H1N1 vaccine at different times, as well as a dose of the standard flu vaccine. Other study locations will administer one dose of the vaccine to their patients. Rockwood Clinic planned to begin enrolling patients in the study at the end of August, and will take blood samples from the participants monthly. If they develop the flu, however, blood testing would begin immediately to gauge their response to the H1N1 vaccine, he says.
Shipman says Rockwood routinely participates in flu vaccine trials, since the vaccines change a little each year as the seasonal flu strain changes. In part because of the high interest in preventing the spread of H1N1, the current study is being handled a little differently, in that information from it will be sent to the U.S. Food and Drug Administration weekly during the study, rather than compiled at the end of the trial, he says.