Protocol Details
VRC 500: Screening Volunteers for Clinical Trials of Investigational Products and Licensed Products Evaluated for Research Purposes
This study is currently recruiting participants.
Summary
Number |
11-I-0164 |
Sponsoring Institute |
National Institute of Allergy and Infectious Diseases (NIAID) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 60 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Keywords |
Prevention;
Vaccine;
Immunity;
Evaluate;
Screen |
Recruitment Keyword(s) |
None |
Condition(s) |
Screening |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute of Allergy and Infectious Diseases |
Background:
- The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health needs healthy volunteers for vaccine clinical trials. This is a screening study that is used to identify healthy volunteers who may be eligible to participate in other clinical trials at the Vaccine Research Center that evaluate investigational vaccines, monoclonal antibodies, and injection devices. The VRC conducts studies that will allow researchers to better understand the immune system and how vaccines and monoclonal antibodies work.
Objectives:
- To screen healthy volunteers for clinical trials at the NIAID VRC.
Eligibility:
- Healthy people between 18 and 60 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 healthy volunteers to participate in clinical trials is an ongoing process.
- Volunteers will be asked about their medical history, including sexual activity and drug use, and a detailed physical exam will be performed.
- Blood and urine samples may be collected, and possibly other tests as needed to evaluate the volunteer's health status.
- Volunteers will not receive any investigational product in this screening protocol.
Eligibility
INCLUSION CRITERIA:
Age: 18 years of age or older
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:
Not Provided
Contacts:
Clinical Trials Number:
NCT01375530