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

Completed

• Conditions: Healthy

• Registration Number: NCT00068926
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-09-03
• Study First Submitted QC: 2003-09-10
• Study First Submitted: 2003-09-11
• Study First Posted: 2003-09-11
• Status Verified: 2011-06-29
• Study Completion: 2011-06-29
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 958

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States

Clinical Alliance for Research and Education - Infectious Diseases, LLC; 🇺🇸 Annandale, Virginia, United States