Screening of Volunteers for Clinical Trials of Investigational or Licensed Vaccines or Antiviral Products

NCT02242968 | Completed

• 2 other identifiers: 14019414-I-0194
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Vaccines and antiviral therapies help prevent and treat diseases. Researchers need a group of healthy volunteers for clinical trials. Clinical trials are studies that test these vaccines and therapies in people. Objective: \- To screen volunteers for clinical trials for investigational or licensed vaccines or drugs to treat or prevent virus infections. Eligibility: \- Healthy adults age 18 or older. Design:

• Participants will be asked questions about their health history, including sexual activity and drug use. They will give blood samples. They may have a physical exam. They may give a urine sample.
• Participants may have the inside of their nose either swabbed or washed with some fluid. The fluid will be collected. They may give a stool sample.
• Participants may have an electrocardiogram. Soft, sticky patches will be attached to participants chest, arms, and legs. They will lie still on a table while the patches detect the heart s electrical signals. A machine will record these signals.
• Participants may have lung function tests. These tests measure the volume of air moving in and out of the lungs. Participants will forcibly blow air into a machine.
• Participants will be told if any tests show a medical problem.
• If a participant is eligible and decides to join an investigational clinical trial, researchers will explain the study and the risks involved. Participants will sign a separate consent for that clinical trial.

Conditions

Vaccines; Antiviral Agents; Immunologic Factors; Physiological Effects of Drugs; Anti-Infective Agents

Keywords

Licensed Vaccines; Blood Draw; Investigational Vaccines; Healthy Volunteers; Eligibility Screening

Outcome Measures

Primary Outcomes (1)

• To develop a pool of subject eligible to participate in clinical trials of investigational or licensed vaccines or antiviral products.

  A pool of subjects qualified to participate in clinical trials.

  Within one year from enrollment of each individual.

Study Arms (1)

Healthy Volunteers

Male and Female healthy volunteers between aged 18 and 65 years.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers, male or female ages 18-65.@@@

You may qualify if:

• Age: 18 or older
• Available to participate for the planned duration of at least one clinical trial for which screening is being done or to donate blood, nasal swab, throat swab, and/or urine in support of assay development
• Able and willing to complete the informed consent process
• Agree to have blood and/or urine, stool, nasal swab, or wash samples collected as needed for the clinical trial screening or sample donation process
• Agree to participate in procedures, such as electrocardiogram or pulmonary function tests, as may be needed for the clinical trial screening process
• Do not have plans to become pregnant while on this study
• Able to provide a medical history and other relevant personal information as appropriate

You may not qualify if:

• 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
• If planning to enroll in a clinical trial, the receipt of immunoglobulin within the past 6 months or anticipated within the next year
• Any other condition that in the opinion of the investigator would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study or a specimen donation.
• Use of recreational drugs or alcohol dependency or abuse

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Richard T Davey, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 17, 2014
• Study Start: April 24, 2023
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

US (1)