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Volunteer Screening for Vaccine and Antivirals Clinical Trials

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01593709
Recruitment Status : Recruiting
First Posted : May 8, 2012
Last Update Posted : September 15, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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
Normal Physiology

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, nasal swab, or nasopharyngeal wash secretions may be tested for viruses or antibodies to the virus. Additional testing, such as an electrocardiogram (EKG), chest radiograph (CXR), and pulmonary function tests (PFTs) may be done. 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.

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Study Type : Observational
Estimated Enrollment : 2000 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
Actual Study Start Date : November 27, 2012

Group/Cohort
Cohort 1
Healthy adults; age 18 or older



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: At every patient contact. ]
    Eligibility will be determined.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers aged 18 or older.
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 participate in proceduresas needed for the clinical trial screening process.

EXCLUSION CRITERIA:

  1. A known 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, or planning to become pregnant in the near future
  3. Use of a medication that significantly alters the immune system within the past 6 months or anticipated within the next year (e.g. immunoglobulin, systemic corticosteroids > prednisone equivalent of 10 mg/kg/day)
  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. Abuse of illicit drugs, alcohol abuse, or alcohol dependency within the last 6 months
  6. Known to be infected with HIV or Hepatitis B and/or C.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593709


Contacts
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Contact: Kayla D Morgan (301) 761-5671 kayla.morgan@nih.gov
Contact: Jeffrey I Cohen, M.D. jcohen@niaid.nih.gov

Locations
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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
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Principal Investigator: Jeffrey I Cohen, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01593709    
Other Study ID Numbers: 120121
12-I-0121
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: September 15, 2020
Last Verified: June 5, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Anti-infective agents
ANTI-VIRAL AGENTS
Healthy Volunteers