Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Volunteer Screening for Vaccine and Antivirals Clinical Trials

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT01593709
First received: May 5, 2012
Last updated: August 31, 2016
Last verified: May 2016

May 5, 2012
August 31, 2016
April 2012
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To screen subjects for their eligibility to participate in clinical trials of investigational or licensed vaccines, antiviral products, or live virus challenge studies being evaluated for research purposes. [ Time Frame: Every patient contact ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01593709 on ClinicalTrials.gov Archive Site
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Volunteer Screening for Vaccine and Antivirals Clinical Trials
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 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. In some cases blood may be tested for viral DNA or RNA and urine, stool, or nasal wash, or nasal swab may be tested for viruses. Additional testing, such as an electrocardiogram (EKG), 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.
Observational
Time Perspective: Prospective
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Healthy Volunteer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
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  • 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
Both
18 Years to 99 Years   (Adult, Senior)
Yes
Contact: Jenny Ahn (301) 435-4799 jenny.ahn@nih.gov
Contact: Jeffrey I Cohen, M.D. jcohen@niaid.nih.gov
United States
 
NCT01593709
120121, 12-I-0121
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Jeffrey I Cohen, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP