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Protocol 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
Gender: Male & Female
Min Age: 18
Max Age: 50

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Influenza;
Human;
Challenge Study;
Healthy Volunteer

Recruitment Keyword(s)

Healthy Volunteer;
HV

Condition(s)

Influenza, Human

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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.

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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


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Citations:

Anderson MJ, Heath RB. Cell mediated immunity in experimental influenza and parainfluenza infection. Dev Biol Stand. 1977 Jun 1-3;39:379-83.

Brown TA, Murphy BR, Radl J, Haaijman JJ, Mestecky J. Subclass distribution and molecular form of immunoglobulin A hemagglutinin antibodies in sera and nasal secretions after experimental secondary infection with influenza A virus in humans. J Clin Microbiol. 1985 Aug;22(2):259-64.

Carrat F, Vergu E, Ferguson NM, Lemaitre M, Cauchemez S, Leach S, Valleron AJ. Time lines of infection and disease in human influenza: a review of volunteer challenge studies. Am J Epidemiol. 2008 Apr 1;167(7):775-85. Epub 2008 Jan 29.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Matthew J. Memoli, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
BG 33 RM 3E19A.4
33 NORTH DR
BETHESDA MD 20814
(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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