The University of Iowa is one of several centers in the United States participating in National Institutes of Health clinical studies of H1N1 influenza vaccines. UI Health Care is the lead site for one of these studies. The trial aims to help determine the right dosage of H1N1 vaccine and how many times the dosage should be administered. Dr. Patricia Winokur joins me now by phone to tell us more about the study. Dr. Winokur is an internal medicine specialist, associate dean for clinical research, and principal investigator of the study.
Why was Iowa chosen as a site for the H1N1 trial?
In 2007, The University of Iowa competed nationally to become one of the eight vaccine and treatment evaluation units that are sponsored by the NIH. We were awarded the contract—really—based on the fact that we have a history of being able to manage very large-scale clinical trials and still maintain a very high standard of accuracy as we run the trials; so we are now what’s considered one of the ‘go to’ sites for the government to help run very important trials that they need run in a very safe and efficient manner.
Who are you asking to participate in the study?
Right now we’re studying healthy adults who are 18 to 64 and 65 and older.
What are participants asked to do as part of the study?
Individuals who participate in the study will get two vaccinations over three weeks. They’ll have five face-to-face visits over six to seven weeks, and in that there’ll be five blood draws. After that, we’ll follow them with telephone calls up through month seven, and the reason for the telephone calls is to assess safety of the vaccine. So individuals will get either 15 micrograms of vaccine, or 30 micrograms of vaccine, and each will receive two doses of the vaccine—or two shots—three weeks apart.
How long will the study last?
Participants will be enrolled in the study for seven months.
How long are you going to be studying things overall for the entire study?
Actually, this is a very unusual trial because the data that we get from the trial is going to help the government decide how to vaccinate people this fall. So though people are going to be enrolled for seven months in this trial; we’re going to be collecting data almost in real time. Safety data will be entered every time we contact the patient (and that will be five visits in six weeks) and we’re drawing the bloods and sending them the same day that we’re drawing them and they’re going to be analyzed as quickly as possible at the central lab. We think that we’re going to have data within four to five weeks for the first shot, and then within seven to eight weeks after that second shot. So we’re getting data very quickly.
What is the goal of the study as far as vaccine dosage is concerned?
We’re hoping to understand whether people will need the regular dose of vaccine, which is 15 micrograms. We know in the past in other flu years where we have novel strains that sometimes we need a more potent vaccine and that’s why we’re looking at the 30 microgram dose. Most years we only need one shot to protect us. But, again, since this is such a novel virus that we’re seeing in the population, it may be this time we’re going to need two doses to get everyone’s immune system to the point that they’re protected.
Are you still looking for participants?
Right at this moment we have enough volunteers for the trial that we’re running today, but we anticipate having several other trials starting in the next few weeks. We’re going to be starting, hopefully, a trial on kids; and then we have another study that we’ll be starting in adults—again, in that 18 to 64 and 65-plus age range.
If someone wanted to learn more about participating—where should they start?
They should give us a call and the telephone number is 356-4848. |
