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

Physiological Effects of Drugs Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT02242968
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Jocelyn Voell, R.N.
• Phone: (301) 435-7913
• Email: jvoell@niaid.nih.gov
• Status: Recruiting
• Start date: April 24, 2023
• Completion date: September 30, 2024