Department of Internal Medicine UI Smallpox Study Invites Adults Born After 1971  Patricia L. Winokur, M.D. Associate Professor Division of Infectious Diseases
7/12/2007 Adults born after 1971 who have never received a smallpox vaccine and are in overall good health are invited to participate in a smallpox vaccine study at the University of Iowa. The study will compare the effectiveness and safety of a new study vaccine called IMVAMUNE, an FDA-approved vaccine called Dryvax and certain combinations of the two vaccines. Individuals who are pregnant, allergic to eggs or have had severe reactions to a vaccine are not eligible to participate. People with eczema, heart conditions and high blood pressure also are not eligible. In addition, women of childbearing potential who participate must agree to use acceptable contraception and not become pregnant during the study. Participation involves eight to 12 visits over approximately one year to UI Hospitals and Clinics. An initial two-hour screening visit will determine who is eligible to participate. Participants then will be randomly assigned to one of five study groups. Some participants may be assigned to the group receiving placebo, a substance which does not contain any active vaccine. All participants will be asked to record their temperature and certain other information in a daily diary. The study will cover the cost of all vaccines/placebos, tests and exams. Compensation will be available to study participants. The study is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Approximately 215 participants will be enrolled at seven sites nationwide, including an expected 70 individuals at the UI. Patricia Winokur, M.D., UI associate professor of internal medicine, is the principal investigator for the UI site. For more information, call 319-384-7245 or 319-384-9569 between 8 a.m.
and 5 p.m. Monday through Friday or email geraldine-dull@uiowa.edu. |
