Screening of Volunteers for Clinical Trials of Investigational or Licensed Vaccines or Antiviral Products
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/17/2019 |
| Start Date: | September 16, 2014 |
| End Date: | September 30, 2024 |
| Contact: | Jocelyn Voell, R.N. |
| Email: | jvoell@niaid.nih.gov |
| Phone: | (301) 435-7913 |
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.
- 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.
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.
Blood samples will also be stored for future research. 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.
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.
Blood samples will also be stored for future research. 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.
- INCLUSION CRITERIA:
1. Age: 18-65 years of age
2. Available to participate for the planned duration of at least one clinical trial
for which screening is being done
3. Able and willing to complete the informed consent process
4. Agree to have blood and/or urine, stool, nasal swab or wash samples collected and
stored for future studies of investigational or licensed products, the immune
system, and/or infectious diseases
5. Agree to participate in procedures, such as electrocardiogram or pulmonary
function tests, as needed for the clinical trial screening process
6. Do not have plans to become pregnant while on this study
7. Able to provide a complete medical history and other relevant personal
information as appropriate
EXCLUSION CRITERIA:
1. A condition that requires active medical intervention or monitoring to avert serious
danger to the participant s health or well-being
2. Known to be pregnant or breast-feeding
3. Receipt of immunoglobulin within the past 6 months or anticipated within the next year
4. 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
5. Use of recreational drugs or alcohol dependency or abuse
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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