Explore the NIHProtocol Details
VRC 500:Screening of Volunteers for Clinical Trials of Investigational Products and Licensed Products Evaluated for Research Purposes
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
11-I-0164 |
Sponsoring Institute |
National Institute of Allergy and Infectious Diseases (NIAID) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Special Instructions |
Currently Not Provided |
Keywords |
Prevention; |
Recruitment Keyword(s) |
Healthy Volunteer; |
Condition(s) |
Human Volunteers |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
- The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health needs healthy volunteers for vaccine clinical trials. These trials will allow researchers to study vaccines and injection devices. These studies will also allow researchers to understand the immune system and how vaccines work. In this protocol, researchers will screen healthy volunteers for these future trials.
Objectives:
- To screen healthy volunteers for clinical trials at the NIAID.
Eligibility:
- Healthy people between 18 and 70 years of age. They must be available to take part in clinical trials and be able to provide blood for research studies.
Design:
- Screening for a clinical trial may begin several months before the vaccine clinical trial begins.
- Volunteers will be screened with a physical exam and medical history. They may also answer questions about sexual activity and drug use.
- Volunteers will provide blood samples and possibly urine samples. They may have other tests as needed for the study.
- Volunteers will not receive any treatment in this screening trial.
Eligibility
INCLUSION CRITERIA:
Age: 18-70 years of age
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 have blood and/or tissue samples collected and stored for future studies of investigational products, the immune system, and/or other medical conditions
EXCLUSION CRITERIA:
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
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Barney S. Graham, M.D. National Institute of Allergy and Infectious Diseases (NIAID) |
Ingelise Gordon, R.N. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health Building 10 Room 12S253 10 Center Drive Bethesda, Maryland 20892 (301) 451-8715 vaccines@nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT01375530
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