Screening Volunteers for Clinical Trials

NCT01375530 | Recruiting

• 2 other identifiers: 11016411-I-0164
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 4

Brief Summary

Background: \- The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health needs healthy volunteers for vaccine clinical trials. This is a screening study that is used to identify healthy volunteers who may be eligible to participate in other clinical trials at the Vaccine Research Center that evaluate investigational vaccines, monoclonal antibodies, and injection devices. The VRC conducts studies that will allow researchers to better understand the immune system and how vaccines and monoclonal antibodies work. Objectives: \- To screen healthy volunteers for clinical trials at the NIAID VRC. Eligibility: \- Healthy people between 18 and 60 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 healthy volunteers to participate in clinical trials is an ongoing process.
• Volunteers will be asked about their medical history, including sexual activity and drug use, and a detailed physical exam will be performed.
• Blood and urine samples may be collected, and possibly other tests as needed to evaluate the volunteer's health status.
• Volunteers will not receive any investigational product in this screening protocol....

Conditions

Screening

Keywords

Prevention; Vaccine; Immunity; Evaluate; Screen

Outcome Measures

Primary Outcomes (1)

• To screen subjects for their eligibility to participate in clinical trials.

  Duration of subject participation is variable, and may last from a few weeks to several months for each subject.

  Ongoing

Study Arms (1)

1

Healthy adults 18 - 60 years old

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

You may qualify if:

• Age: 18 years of age or older
• 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

You may not qualify if:

• 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 (4)

Emory University

Atlanta, Georgia, 30030, United States

COMPLETED

Univ of MD School of Medicine Center for Vaccine Development & Global Health

Baltimore, Maryland, 21201-1595, United States

ACTIVE NOT RECRUITING

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

University of Pennsylvania-UPenn

Philadelphia, Pennsylvania, 19104-6056, United States

COMPLETED

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Lasonji A Holman, C.R.N.P.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VRC Recruitment

CONTACT

(866) 833-5433; vrcrecruitment@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 17, 2011
• Study Start: August 16, 2011
• Last Updated: May 1, 2026

Record last verified: 2026-03-17

Locations

US (4)