Screening Volunteers for Clinical Trials
Background: - 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.
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- Accepts Healthy Volunteers
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
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
- Study Type
- Observational Model
- Time Perspective
- NCT ID
- National Institute of Allergy and Infectious Diseases (NIAID)
Study ContactIngelise Gordon, R.N.
The purpose of this study is to screen potential study subjects to determine if they are eligible for clinical trials of investigational products conducted by the Vaccine Research Center (VRC), NIAID, NIH. Educational materials on the investigational products and protocols will be reviewed with and provided to subjects during participation in the screening protocol. Approximately 4,000 adults, ages 18-70 years, will be enrolled.