Screening of Volunteers for Clinical Trials of Investigational or Licensed Vaccines or Antiviral Products

Vaccines and antiviral therapies are critical for prevention and treatment of viral diseases. Among other things, testing of vaccines or antiviral medications requires knowing whether the prospective subject has been previously infected by the virus to be studied. We will recruit healthy persons for this study and screen them for their eligibility to potentially participate in clinical trials of investigational or licensed vaccines or antiviral products. In most cases this will involve a medical history, physical examination, and obtaining blood to test for past exposure to one or more viruses being studied in ongoing and upcoming vaccine or antiviral therapy trials. In some cases, blood may be tested for viral DNA or RNA and urine, stool, nasal swab, or nasal wash may be tested for viruses. Additional testing, such as an electrocardiogram (EKG) and pulmonary function tests (PFTs) may also be done. In a subset of volunteers not screening for enrollment in a clinical trial but willing to donate a small volume of blood, nasal swab, throat swab, and/or urine in support of research assay development, no additional testing is anticipated. Overall, this study should 1) help us to identify a group of healthy volunteers who will be eligible, based on testing for their prior exposure to viruses, to participate in vaccine or antiviral therapy trials, and 2) allow for ready procurement of biological specimens from healthy volunteers to facilitate rapid research assay development.