Volunteer Screening for Vaccine and Antivirals Clinical Trials

Vaccines and antiviral therapies are critical for prevention and treatment of viral diseases. Testing of vaccines, antiviral medications, or live virus challenge studies in volunteers may requires knowing whether the subject has been previously infected by the virus. We will recruit healthy persons for this study and screen them for their eligibility to participate in clinical trials of investigational vaccines or antiviral products, investigational studies of licensed products, or live virus challenge studies. In most cases this will involve a medical history, physical examination, and obtaining blood to test for antibodies to the virus being studied in a vaccine or antiviral therapy trial or live virus challenge study. In some cases blood may be tested for viral DNA or RNA and urine, stool, saliva, nasal swab, or nasopharyngeal wash secretions may be tested for viruses or antibodies to the virus. Additional testing, such as an electrocardiogram (EKG), chest radiograph (CXR), and pulmonary function tests (PFTs) may be done. Samples will also be stored for future research. This study should help us to identify a group of volunteers that will be eligible, based on testing for their prior exposure to viruses, to participate in vaccine or antiviral therapy trials, or live virus challenge studies, .conducted by the Laboratory of Infectious Diseases, NIAID at the NIH Clinical Center.

• INCLUSION CRITERIA:

• Age: 18 years of age or older
• Available to participate for the planned duration of the clinical trial for which the screening is being done
• Able and willing to complete the informed consent process
• Agree to participate in proceduresas needed for the clinical trial screening process.

Exclusion criteria

• A known condition that requires active medical intervention or monitoring to avert serious danger to the participant s health or well-being
• Known to be pregnant or breast-feeding, or planning to become pregnant in the near future
• Use of a medication that significantly alters the immune system within the past 6 months or anticipated within the next year (e.g. immunoglobulin, systemic corticosteroids > prednisone equivalent of 10 mg/kg/day)
• Any other condition that in the opinion of the investigator would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study
• Abuse of illicit drugs, alcohol abuse, or alcohol dependency within the last 6 months
• Known to be infected with HIV or Hepatitis B and/or C.