Volunteer Screening for Vaccine and Antivirals Clinical Trials
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 2/7/2019 |
| Start Date: | May 15, 2012 |
| Contact: | Krista S Gangler, R.N. |
| Email: | krista.gangler@nih.gov |
| Phone: | (301) 761-6437 |
Screening of Volunteers for Clinical Trials of Investigational and Licensed Vaccines, Antiviral Products, or Live Virus Challenge Studies
Background:
- Vaccines and antiviral therapies are critical for preventing and treating viral diseases.
Testing these vaccines and drugs often requires healthy volunteers. To ensure that volunteers
are healthy and eligible to participate in these studies, they will be screened before the
start of the study. This screening may involve a medical history, physical exam, and blood
test. Other samples may also be collected. This study will help identify volunteers who are
eligible to participate in vaccine or antiviral therapy trials.
Objectives:
- To screen volunteers for clinical trials of vaccines or drugs to treat or prevent virus
infections.
Eligibility:
- Healthy volunteers at least 18 years of age.
Design:
- Screening may begin several months before the start of the clinical trial. Participants
may come to the National Institutes of Health clinic one or more times.
- Participants may be screened with a physical exam and medical history. Blood samples
will be collected. Other samples may also be collected, including urine, nasal wash,
nasal swab, or stool samples. All samples will be stored for reference by the study
researchers.
- Vaccines and antiviral therapies are critical for preventing and treating viral diseases.
Testing these vaccines and drugs often requires healthy volunteers. To ensure that volunteers
are healthy and eligible to participate in these studies, they will be screened before the
start of the study. This screening may involve a medical history, physical exam, and blood
test. Other samples may also be collected. This study will help identify volunteers who are
eligible to participate in vaccine or antiviral therapy trials.
Objectives:
- To screen volunteers for clinical trials of vaccines or drugs to treat or prevent virus
infections.
Eligibility:
- Healthy volunteers at least 18 years of age.
Design:
- Screening may begin several months before the start of the clinical trial. Participants
may come to the National Institutes of Health clinic one or more times.
- Participants may be screened with a physical exam and medical history. Blood samples
will be collected. Other samples may also be collected, including urine, nasal wash,
nasal swab, or stool samples. All samples will be stored for reference by the study
researchers.
Vaccines and antiviral therapies are critical for prevention and treatment of viral diseases.
Testing of vaccines, antiviral medications, or live virus challenge studies in volunteers may
requires knowing whether the subject has been previously infected by the virus. We will
recruit healthy persons for this study and screen them for their eligibility to participate
in clinical trials of investigational vaccines or antiviral products, investigational studies
of licensed products, or live virus challenge studies. In most cases this will involve a
medical history, physical examination, and obtaining blood to test for antibodies to the
virus being studied in a vaccine or antiviral therapy trial or live virus challenge study. In
some cases blood may be tested for viral DNA or RNA and urine, stool, saliva or nasal wash or
secretions may be tested for viruses or antibodies to the virus. Additional testing, such as
an electrocardiogram (EKG), chest radiograph (CXR), pulmonary function tests (PFTs), and
collection of cervicovaginal secretions may be done. Blood samples will also be stored for
future research. This study should help us to identify a group of volunteers that will be
eligible, based on testing for their prior exposure to viruses, to participate in vaccine or
antiviral therapy trials, or live virus challenge studies, .conducted by the Laboratory of
Infectious Diseases, NIAID at the NIH Clinical Center.
Testing of vaccines, antiviral medications, or live virus challenge studies in volunteers may
requires knowing whether the subject has been previously infected by the virus. We will
recruit healthy persons for this study and screen them for their eligibility to participate
in clinical trials of investigational vaccines or antiviral products, investigational studies
of licensed products, or live virus challenge studies. In most cases this will involve a
medical history, physical examination, and obtaining blood to test for antibodies to the
virus being studied in a vaccine or antiviral therapy trial or live virus challenge study. In
some cases blood may be tested for viral DNA or RNA and urine, stool, saliva or nasal wash or
secretions may be tested for viruses or antibodies to the virus. Additional testing, such as
an electrocardiogram (EKG), chest radiograph (CXR), pulmonary function tests (PFTs), and
collection of cervicovaginal secretions may be done. Blood samples will also be stored for
future research. This study should help us to identify a group of volunteers that will be
eligible, based on testing for their prior exposure to viruses, to participate in vaccine or
antiviral therapy trials, or live virus challenge studies, .conducted by the Laboratory of
Infectious Diseases, NIAID at the NIH Clinical Center.
- INCLUSION CRITERIA:
1. Age: 18 years of age or older
2. Available to participate for the planned duration of the clinical trial for which
the screening is being done
3. Able and willing to complete the informed consent process
4. Agree to have blood and/or urine, stool, nasal wash samples, or cervicovaginal
secretion 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.
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 illicit 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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