Screening Volunteers for Influenza Challenge Studies
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|ClinicalTrials.gov Identifier: NCT01386424|
Recruitment Status : Recruiting
First Posted : July 1, 2011
Last Update Posted : April 19, 2018
- 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|
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|
|Official Title:||Screening for LID Clinical Studies Unit Healthy Volunteer Protocols|
|Study Start Date :||June 30, 2011|
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT01386424
|Contact: Holly A Baus, R.N.||(301) email@example.com|
|Contact: Matthew J Memoli, M.D.||(301) firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Matthew J Memoli, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|