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

NCT00068926 | Completed

• 2 other identifiers: 03028503-I-0285
• Study Type: observational
• Target: 958
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

Biodefense; Prevention; Emergent; Virus; Immune Response; Healthy Volunteer; HV

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 70 years of age
• Available to participate for the planned duration of the investigational vaccine study for which the screening is being done (vaccine studies may require 6 months to 18 months of clinic visits).
• Able and willing to complete the informed consent process.
• Agree to have blood stored for future studies of the vaccine, the immune system, and/or other medical conditions.

You may not qualify if:

• Known to be infected with HIV, syphilis, tuberculosis, hepatitis B or hepatitis C.
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Clinical Alliance for Research and Education - Infectious Diseases, LLC

Annandale, Virginia, 22003, United States

Location

Related Publications (1)

• Fauci AS. Infectious diseases: considerations for the 21st century. Clin Infect Dis. 2001 Mar 1;32(5):675-85. doi: 10.1086/319235. Epub 2001 Feb 23.

  PMID: 11229834 BACKGROUND

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 11, 2003
• First Posted: September 11, 2003
• Study Start: September 3, 2003
• Study Completion: June 29, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-06-29

Locations

US (2)