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. 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
🗓️ Study Start (Actual) 16 August 2011
🗓️ Primary Completion (Estimated) N/A
✅ Study Completion (Estimated) N/A
👥 Enrollment (Estimated) 4000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Atlanta, Georgia, United States
📍 Baltimore, Maryland, United States
📍 Bethesda, Maryland, United States
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 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

    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
Ages Eligible for Study: 18 Years to 60 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 June 2011
  • First Submitted that Met QC Criteria 16 June 2011
  • First Posted 17 June 2011

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 June 2024
  • Last Update Posted 25 June 2024
  • Last Verified 21 May 2024