Screening of Volunteers for Clinical Trials of Investigational or Licensed Vaccines or Antiviral … (NCT02242968) | Clinical Trial Compass
CompletedNot Applicable
Screening of Volunteers for Clinical Trials of Investigational or Licensed Vaccines or Antiviral Products
United States9 participantsStarted 2023-04-24
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To develop a pool of subject eligible to participate in clinical trials of investigational or licensed vaccines or antiviral products.
Timeframe: Within one year from enrollment of each individual.
Trial details
NCT IDNCT02242968
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)