Healthy Clinical Trial
Official title:
VRC 300: Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases
Verified date | June 29, 2011 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 958 |
Est. completion date | June 29, 2011 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
- INCLUSION CRITERIA: Age: 18 to 70 years of age Available to participate for the planned duration of the investigational vaccine study for which the screening is being done (vaccine studies may require 6 months to 18 months of clinic visits). Able and willing to complete the informed consent process. Agree to have blood stored for future studies of the vaccine, the immune system, and/or other medical conditions. EXCLUSION CRITERIA: 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. |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Alliance for Research and Education - Infectious Diseases, LLC | Annandale | Virginia |
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Fauci AS. Infectious diseases: considerations for the 21st century. Clin Infect Dis. 2001 Mar 1;32(5):675-85. Epub 2001 Feb 23. — View Citation
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