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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT02242968

Collaborator

(none)

1,000

Enrollment

Location

24.1

Anticipated Duration (Months)

41.4

Patients Per Site Per Month

Study Details

Study Description

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 65.

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.

Condition or Disease	Intervention/Treatment	Phase
Vaccines Antiviral Agents Immunologic Factors Physiological Effects of Drugs Anti-Infective 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. This study should 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 26, 2022

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Healthy Volunteers Male and Female healthy volunteers between aged 18 and 65 years.

Outcome Measures

Primary Outcome Measures

To develop a pool of subject eligible to participate in clinical trials of investigational or licensed vaccines or antiviral products. [Within one year from enrollment of each individual.]
A pool of subjects qualified to participate in clinical trials.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

INCLUSION CRITERIA:

Age: 18-65 years of age
Available to participate for the planned duration of at least one clinical trial for which screening is being done
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 process
Agree to participate in procedures, such as electrocardiogram or pulmonary function tests, as needed for the clinical trial screening process
Do not have plans to become pregnant while on this study
Able to provide a complete 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
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
Use of recreational drugs or alcohol dependency or abuse