Screening Volunteers for Influenza Challenge Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01386424
Recruitment Status : Recruiting
First Posted : July 1, 2011
Last Update Posted : April 19, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief Summary:


- 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.


- To screen healthy volunteers for future influenza challenge studies.


  • Healthy people between the ages of 18 and 65 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.


  • 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.

Condition or disease
Influenza, Human

Detailed Description:

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.

While initially the protocol was designed to screen participants for influenza challenge studies, we have expanded our scope of research to include emerging and re-emerging infectious diseases.The primary goal of this study is to collect and store serum and RNA samples and obtain clinical and laboratory data from volunteers to determine in advance if they are potentially eligible to participate in future clinical studies. To accomplish this objective, up to 5000 participants will be enrolled in this protocol at the NIH Clinical Center clinic or day hospital in order to maintain a pool of participants who have been evaluated and can be screened for future LID Clinical Studies protocols.

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
Study Start Date : June 30, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Primary Outcome Measures :
  1. The primary goal of this study is to collect and store serum and RNAsamples and obtain clinical and laboratory data from volunteers todetermine in advance if they are potentially eligible to participate infuture LID CSU protocols. [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

    1. Greater than or equal to 18 and less than or equal to 65 years old, and have no significant health abnormalities
    2. Willing to consider taking part in a future LID Clinical Studies Unit healthy volunteer study
    3. A female participant 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 spceific 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 participant's entry into the study and is the sole sexual partner for the female participant; 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.

4. Willing to have samples stored for future research


  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. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01386424

Contact: Holly A Baus, R.N. (301) 761-6800
Contact: Matthew J Memoli, M.D. (301) 443-5971

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 Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Matthew J Memoli, M.D. National Institute of Allergy and Infectious Diseases (NIAID)

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT01386424     History of Changes
Other Study ID Numbers: 110183
First Posted: July 1, 2011    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: January 3, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Challenge Study
Healthy Volunteer

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases