VRC 300: Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases
Completed
Conditions studied: Healthy
In brief
This protocol will screen healthy normal volunteers for participation in studies of vaccines under development at NIAID's Vaccine Research Center. Of interest are vaccines for: * Newly identified infectious diseases such as SARS. * Infectious diseases of concern as possible bioweapons, such as smallpox and Ebola virus * Emerging infectious diseases that are more widespread geographically than in the past, such as West Nile virus * For preventing diseases such as tuberculosis and malaria. Healthy normal volunteers between 18 and 70 years of age may be eligible for this protocol. Screening begins about 1 to 6 months before the start of the vaccine study. Participants will have a physical examination and health history, including questions about sexual activity and drug use. Over the course of the screening visits, participants will be asked to give urine and blood samples to test for various infections and other medical problems. Women capable of getting pregnant will be given a pregnancy test. Women who are pregnant or breastfeeding will not be enrolled in the study. At the end of the screening, participants will be informed about which vaccines are currently being tested in clinical trials for which they may be eligible. Once participants enroll in a vaccine study, their participation in the screening protocol ends.
Key facts
- Study ID
- NCT00068926
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 958
- Starts
- 2003-09-03
- Expected to finish
- 2011-06-29
- Last updated by the study team
- 2017-07-02
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Known to be infected with HIV, syphilis, tuberculosis, hepatitis B or hepatitis C.
- A condition in which repeated blood draws or injections pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.
- A 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.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
- Clinical Alliance for Research and Education - Infectious Diseases, LLC — Annandale, Virginia, United States
Full record on ClinicalTrials.gov
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