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

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.

Study Overview

• Status: Completed
• Conditions: Physiological Effects of Drugs; Anti-Infective Agents; Vaccines; Immunologic Factors; Antiviral Agents

Detailed Description

Vaccines and antiviral therapies are critical for prevention and treatment of viral diseases. Among other things, testing of vaccines or antiviral medications requires knowing whether the prospective subject has been previously infected by the virus to be studied. We will recruit healthy persons for this study and screen them for their eligibility to potentially participate in clinical trials of investigational or licensed vaccines or antiviral products. In most cases this will involve a medical history, physical examination, and obtaining blood to test for past exposure to one or more viruses being studied in ongoing and upcoming vaccine or antiviral therapy trials. In some cases, blood may be tested for viral DNA or RNA and urine, stool, nasal swab, or nasal wash may be tested for viruses. Additional testing, such as an electrocardiogram (EKG) and pulmonary function tests (PFTs) may also be done. In a subset of volunteers not screening for enrollment in a clinical trial but willing to donate a small volume of blood, nasal swab, throat swab, and/or urine in support of research assay development, no additional testing is anticipated. Overall, this study should 1) help us to identify a group of healthy volunteers who will be eligible, based on testing for their prior exposure to viruses, to participate in vaccine or antiviral therapy trials, and 2) allow for ready procurement of biological specimens from healthy volunteers to facilitate rapid research assay development.

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

• INCLUSION CRITERIA:
• 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

EXCLUSION CRITERIA:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy Volunteers; Male and Female healthy volunteers between aged 18 and 65 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Richard T Davey, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2023
• Primary Completion (Actual): May 15, 2025
• Study Completion (Actual): May 15, 2025

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: September 16, 2014
• First Posted (Estimated): September 17, 2014

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Blood Draw; Licensed Vaccines; Investigational Vaccines; Eligibility Screening
• Other Study ID Numbers: 140194; 14-I-0194

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No