Volunteer Screening for Vaccine and Antivirals Clinical Trials

This study is currently recruiting participants.
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01593709
First received: May 5, 2012
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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, or stool samples. All samples will be stored for reference by the study researchers....

Condition
Healthy Volunteer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Screening of Volunteers for Clinical Trials of Investigational and Licensed Vaccines, Antiviral Products, or Live Virus Challenge Studies

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1000
Study Start Date: April 2012
Detailed Description:

Vaccines and antiviral therapies are critical for prevention and treatment of viral diseases. Testing of vaccines and antiviral medications in volunteers 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. 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 may be tested for viruses. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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, or nasal wash samples collected and stored for future studies of investigational products, the immune system, and/or infectious diseases

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593709

Contacts
Contact: Siu-Ping Turk, R.N. (301) 451-7661 sturk@cc.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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
NIAID Laboratory of Infectious Diseases
Investigators
Principal Investigator: Jeffrey I Cohen, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01593709     History of Changes
Other Study ID Numbers: 120121, 12-I-0121
Study First Received: May 5, 2012
Last Updated: March 26, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Healthy Volunteers

Additional relevant MeSH terms:
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014