VRC 300: Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases

Status:	Archived
Conditions:	Healthy Studies, Infectious Disease
Therapuetic Areas:	Immunology / Infectious Diseases, Other
Healthy:	No
Age Range:	Any
Updated:	7/1/2011

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.

STUDY DESIGN: The purpose of the study is to screen potential study volunteers to determine
if they are eligible for infectious disease vaccine clinical trials being sponsored by the
Vaccine Research Center (VRC) at the NIH Clinical Center. All work will be conducted by the
VRC Clinic of the National Institutes of Health or IRB-approved extramural sites that are
collaborating with the VRC Clinic. Educational materials on vaccines will be reviewed with
and provided to subjects before enrollment into the study.

SUBJECTS: Approximately 3,000 healthy adults; age 18-70 years.

STUDY DURATION: Duration of 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 vaccine study, is found to be ineligible for all vaccine studies or declines to
participate in any vaccine studies.

STUDY EVALUATIONS: Evaluations usually include history, physical examinations and
laboratory tests. Only those evaluations needed to determine eligibility for a particular
study will be done. Evaluations other than those described in this protocol may be done if
necessary for eligibility for a study. Blood will also be collected for storage.

We found this trial at

sites

National Institutes of Health Clinical Center

9000 Rockville Pike
Bethesda, Maryland 20892

301-496-2563