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Screening Volunteers for Influenza Challenge Studies

This study is currently recruiting participants.
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01386424
First received: June 30, 2011
Last updated: March 14, 2014
Last verified: March 2014

June 30, 2011
March 14, 2014
June 2011
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Complete list of historical versions of study NCT01386424 on ClinicalTrials.gov Archive Site
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Screening Volunteers for Influenza Challenge Studies
Screening of Volunteers for Influenza Human Challenge Studies

Background:

- Influenza (the flu) is highly infectious and contagious. It causes considerable illness in the United States each year. The most severely affected are the very young, sick, and elderly. Researchers want to find healthy volunteers for influenza "challenge studies." In these studies, doctors expose a person to a flu virus. Then they study the flu through the body's natural healing process. This information will help to find better ways to prevent the flu. It may also improve the treatment of people who get the flu.

Objectives:

- To screen healthy volunteers for future influenza challenge studies.

Eligibility:

  • Healthy people between the ages of 18 and 50 who do not routinely smoke.
  • People who share the same apartment or house with people at least 65 years of age or children under age 5 will not be eligible.
  • People who share living quarters with nursing home residents, people with chronic or acute medical conditions, or people with cancer or a compromised immune system are also ineligible.

Design:

  • The 3- to 5-hour screening exam includes the following:
  • Medical history and physical exam
  • Standard blood tests including pregnancy and HIV tests
  • Standard urine drug testing
  • Electrocardiogram (ECG) to test heart rhythm and function
  • Chest x-ray
  • Eligible volunteers are enrolled in the study for up to 1 year, until they take part in a virus challenge study, or are found to be ineligible to participate.
  • Volunteers may withdraw from the study pool at any time.

The high morbidity and mortality associated with both pandemic and seasonal influenza and the anticipation for future influenza pandemics puts influenza front and center in infectious disease research. Because the natural history and pathogenesis of human influenza has not been well characterized and cannot be adequately studied in animal models or with current in vitro techniques, important questions about influenza pathogenesis can only be approached through human challenge studies.

Previous human challenge studies have addressed some aspects of the natural history by evaluating the timing of viral replication, shedding, clinical symptoms, and innate and adaptive immune responses. Although these studies have provided important information, all but one was performed prior to 1990. Without exception, these studies had limitations due to the scope of the study and/or the scientific techniques available at that time.

The primary goal of this study is to collect and store serum and PBMC samples and obtain clinical and laboratory data from volunteers to determine in advance if they are potentially eligible to participate in future influenza challenge studies. To accomplish this objective, up to 1000 subjects will be enrolled in this protocol at the NIH Clinical Center clinic or day hospital in order to maintain a pool of subjects who have been evaluated and can be screened for future influenza challenge studies.

Observational
Time Perspective: Prospective
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Influenza, Human
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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. Greater than or equal to 18 and less than or equal to 50 years old, and have no significant health abnormalities
    2. Willing to consider taking part in a future influenza challenge study
    3. Non-habitual smoker (habitual smokers are persons who smoke more than 4 cigarettes or other tobacco products on a weekly basis) and agree to not use tobacco products during participation in any future influenza challenge study
    4. A female subject is eligible for this study if she is any of the following:
  • Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are post-menopausal, as defined by no menses in greater than or equal to 1 year)
  • Of childbearing potential but agrees to practice effective contraception or abstinence (from heterosexual sex) for 4 weeks prior to enrolling into a specific challenge study and during the study.

NOTE: Acceptable methods of contraception may include one or more of the following: 1) male partner who is sterile prior to the female subject s entry into the study and is the sole sexual partner for the female subject; 2) implants of levonorgestrel; 3) injectable progestogen;, 4) an intrauterine device with a documented failure rate of less than 1percent; 5) oral contraceptives; or 6) double barrier methods including diaphragm or condom with a spermicide.

5. Willing to have samples stored for future research

EXCLUSION CRITERIA:

  1. Self-reported history of any significant medical condition including but not limited to:

    • Chronic pulmonary disease (such as asthma, emphysema)
    • Chronic cardiovascular disease (cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects)
    • Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (diabetes mellitus, renal dysfunction, hemoglobinopathies)
    • Immunosuppression or cancer
    • Neurological and neuro-developmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures)
    • Drug and/or alcohol dependency and/or abuse
  2. Individuals with close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to:

    Persons 65 years of age or older

    Children less than 5 years of age

    Residents of nursing homes

    Close contacts of any age with significant chronic medical conditions such as:

    • Chronic pulmonary disease (e.g. asthma)
    • Chronic cardiovascular disease (e.g. cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects)
    • Neurological and neuro-developmental conditions (e.g. cerebral palsy, epilepsy, stroke, seizures, etc.)
    • Contacts who require medical follow-up or hospitalization during the past 5 years because of chronic disease (e.g. diabetes mellitus, renal dysfunction, hemoglobinopathies)
    • Immunosuppression or cancer
    • Children and teenagers who are receiving long-term aspirin therapy
    • Women who are pregnant or trying to become pregnant or are breast feeding
  3. Known allergy to any of the following:

    • Treatments for influenza (i.e., oseltamivir, nonsteroidals)
    • Antibiotics in two or more classes of antibiotics (i.e., beta-lactams, cephalosporins, fluoroquinolones or glycopeptides [e.g. vancomycin])
  4. Any condition that, in the judgment of the Principal Investigator, is a contraindication to protocol participation or impairs the volunteer s ability to give informed consent
Both
18 Years to 50 Years
Yes
Contact: Rani S Athota (301) 594-0803 rani.athota@nih.gov
Contact: Matthew J Memoli, M.D. (301) 443-5971 mm982v@nih.gov
United States
 
NCT01386424
110183, 11-I-0183
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National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Matthew J Memoli, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
March 2014

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