Volunteer Screening for Vaccine and Antivirals Clinical Trials

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease
Healthy Volunteer

Detailed Description:

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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	1000 participants
Observational Model:	Other
Time Perspective:	Prospective
Official Title:	Screening of Volunteers for Clinical Trials of Investigational and Licensed Vaccines, Antiviral Products, or Live Virus Challenge Studies
Study Start Date :	May 15, 2012

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

• 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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Krista S Gangler, R.N.	(301) 761-6437	krista.gangler@nih.gov
Contact: Jeffrey I Cohen, M.D.		jcohen@niaid.nih.gov

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:	Jeffrey I Cohen, M.D.	National Institute of Allergy and Infectious Diseases (NIAID)

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

NIH Clinical Center Detailed Web Page 

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT01593709 History of Changes
Other Study ID Numbers:	120121; 12-I-0121
First Posted:	May 8, 2012
Last Update Posted:	April 4, 2018
Last Verified:	March 27, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):

Healthy Volunteers

Additional relevant MeSH terms:

Antiviral Agents; Anti-Infective Agents