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Screening of Volunteers for Influenza Human Challenge Studies


N/A
18 Years
50 Years
Open (Enrolling)
Both
Influenza, Human

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Trial Information

Screening of Volunteers for Influenza Human Challenge Studies


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.

Inclusion Criteria


- 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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Matthew J Memoli, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Allergy and Infectious Diseases (NIAID)

Authority:

United States: Federal Government

Study ID:

110183

NCT ID:

NCT01386424

Start Date:

June 2011

Completion Date:

Related Keywords:

  • Influenza, Human
  • Influenza
  • Human
  • Challenge Study
  • Healthy Volunteer
  • HV
  • Influenza, Human

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892