Explore the NIHProtocol Details
Screening of Volunteers for Influenza Human Challenge Studies
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
11-I-0183 |
Sponsoring Institute |
National Institute of Allergy and Infectious Diseases (NIAID) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Special Instructions |
Currently Not Provided |
Keywords |
Influenza; |
Recruitment Keyword(s) |
Healthy Volunteer; |
Condition(s) |
Influenza, Human |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
- 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.
Eligibility
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
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information: |
| Matthew J. Memoli, M.D. National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health BG 33 RM 3E19A4 MSC 3203 33 NORTH DR BETHESDA MD 20892-3203 (301) 443-5971 mm982v@nih.gov |
Rani S. Athota National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health Building 15F1 Room 100 9000 Rockville Pike Bethesda, Maryland 20892 (301) 594-0803 rani.athota@nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT01386424
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