Volunteer Screening for Vaccine and Antivirals Clinical Trials
- Vaccines and antiviral therapies are critical for preventing and treating viral diseases. Testing these vaccines and drugs often requires healthy volunteers. To ensure that volunteers are healthy and eligible to participate in these studies, they will be screened before the start of the study. This screening may involve a medical history, physical exam, and blood test. Other samples may also be collected. This study will help identify volunteers who are eligible to participate in vaccine or antiviral therapy trials.
- To screen volunteers for clinical trials of vaccines or drugs to treat or prevent virus infections.
- Healthy volunteers at least 18 years of age.
- Screening may begin several months before the start of the clinical trial. Participants may come to the National Institutes of Health clinic one or more times.
- Participants may be screened with a physical exam and medical history. Blood samples will be collected. Other samples may also be collected, including urine, nasal wash, or stool samples. All samples will be stored for reference by the study researchers....
|Study Design:||Time Perspective: Prospective|
|Official Title:||Screening of Volunteers for Clinical Trials of Investigational and Licensed Vaccines, Antiviral Products, or Live Virus Challenge Studies|
- To screen subjects for their eligibility to participate in clinical trials of investigational or licensed vaccines, antiviral products, or live virus challenge studies being evaluated for research purposes. [ Time Frame: Every patient contact ] [ Designated as safety issue: No ]
|Study Start Date:||April 2012|
Vaccines and antiviral therapies are critical for prevention and treatment of viral diseases. Testing of vaccines and antiviral medications in volunteers may require 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. 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. In some cases blood may be tested for viral DNA or RNA and urine, stool, or nasal wash may be tested for viruses. Blood 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593709
|Contact: Jenny Ahn||(301) firstname.lastname@example.org|
|Contact: Jeffrey I Cohen, M.D.||email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Jeffrey I Cohen, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|