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.

Study Design:

The purpose of this study is to screen potential study volunteers to determine if they are eligible for clinical trials of investigational products conducted by the Vaccine Research Center (VRC), NIAID, NIH at the NIH Clinical Center. Educational materials on the investigational products and protocols will be reviewed with and provided to subjects during participation in the screening protocol.

Primary Objective:

To screen subjects for their eligibility to participate in clinical trials of investigational products or licensed products being evaluated for research purposes.

Subjects Study:

Approximately 3,000 adults; age 18-70 years

Evaluations:

Evaluations usually include medical history, physical examination and laboratory tests. Evaluations conducted may be limited to those needed to determine eligibility for the clinical trial(s) for which the subject is being screened and may be expanded to include protocol-specific eligibility assessments or assessments based on investigator judgment to assess the volunteer's health as necessary to determine eligibility for a clinical trial. Blood samples will also be collected and stored for future research.

Clinical Sites:

NIH Clinical Center including the Vaccine Evaluation Clinic and its satellite locations such as the VRC Mobile Clinical Trials Unit (MCTU).

Duration of Study Participation:

Duration of subject participation is variable, and may last from a few weeks to several months for each subject. Study participation is complete when the subject enrolls in a study of an investigational product, is found to be ineligible for any studies, or declines to participate in any clinical trials.

• 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