Screening Volunteers for Influenza Challenge Studies
|First Received Date ICMJE||June 30, 2011|
|Last Updated Date||April 21, 2017|
|Start Date ICMJE||June 1, 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The primary goal of this study is to collect and store serum and PBMCsamples and obtain clinical and laboratory data from volunteers todetermine in advance if they are potentially eligible to participate infuture influenza challenge and... [ Time Frame: 1 year ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01386424 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Screening Volunteers for Influenza Challenge Studies|
|Official Title ICMJE||Screening of Volunteers for Influenza Human Challenge and Vaccine Studies|
- 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.
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 and/or vaccine 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 influenza challenge studies.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Influenza, Human|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||5000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
5. Willing to have samples stored for future research
NOTE: Inclusion criteria 3 is applicable for participants that go on to participate in influenza challenge studies, but may not be applicable for other future studies. Documentation will be provided in CRIMSON.
NOTE: Exclusion criteria 2 and 3 are applicable for participants that go on to participate in influenza challenge studies, but may not be applicable for other future challenge studies. Documentation will be provided in CRIMSON.
|Ages||18 Years to 65 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01386424|
|Other Study ID Numbers ICMJE||110183
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institute of Allergy and Infectious Diseases (NIAID)|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 10, 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP