This study is currently recruiting participants.
Number
15-I-0154
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Enrolling by Invitation Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
Yes
Population Exclusion(s)
Non-English Speaking;Children
Keywords
Influenza Like Infection (ILI); Longitudinal Observation; Flu; Immunity; Natural History; Natural History
Recruitment Keyword(s)
None
Condition(s)
Post Influenza
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Allergy and Infectious Diseases
- Influenza is a common viral infection. But it can be deadly for some people. Researchers want to learn more about how the body fights this virus. They want to study this in people who have recently been infected with influenza. They hope this can help them create more effective influenza vaccines.
Objective:
- To learn about long-term changes in the body s immune system after influenza infection.
Eligibility:
- People who have completed a previous LID Clinical Studies Unit influenza challenge study and are willing to have samples stored for future research.
Design:
- Eligible participants will be asked to visit the clinic every 3 months for 2 years.
- During each visit, participants will have blood drawn from an arm vein using a needle and a syringe.
- Participants will have a medical history and physical exam and vital signs performed. This will include blood pressure, heart rate, breathing rate, temperature, weight, and finger-measured blood oxygen. They will answer questions about any medicines taken and possible recent illnesses.
- If participants have symptoms of influenza, they may have a sample taken from the nose. A small <TAB>amount of salt water will be sprayed into the nostril with a squeezable container. The salt water will then run out of the nose and into the container. Or the inside of the nose will be wiped with a swab that is
similar to a Q-tip.
- Participants will complete a health questionnaire once a month on a secure website. Participants may also give their responses over the telephone.
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INCLUSION CRITERIA: 1. Completion of participation in an LID Clinical Studies Unit influenza challenge study or current or prior participation in an LID natural history study. 2. Willing to have samples stored for future research. CO-ENROLLMENT GUIDELINES: Participants may be co-enrolled in other research studies. This will be addressed on a case-by-case basis with the approval of the principal investigator (PI) or associate investigator. If a participant enrolls in another influenza challenge study, the participant will be removed from this study. The participant can re-enroll in this study after completion of the influenza challenge study and will be followed for two years following completion of the most recent influenza challenge study. EXCLUSION CRITERIA: Any condition or event that, in the PI s opinion, may substantially increase the risk associated with study participation or compromise the study s scientific objectives. Conditions that exclude a subject are considered to be unlikely, but an example would include a newly diagnosed medical condition that may alter a participant s immune system and make it unsafe to obtain scheduled blood samples for research purposes.
1. Completion of participation in an LID Clinical Studies Unit influenza challenge study or current or prior participation in an LID natural history study.
2. Willing to have samples stored for future research.
CO-ENROLLMENT GUIDELINES:
Participants may be co-enrolled in other research studies. This will be addressed on a case-by-case basis with the approval of the principal investigator (PI) or associate investigator.
If a participant enrolls in another influenza challenge study, the participant will be removed from this study. The participant can re-enroll in this study after completion of the influenza challenge study and will be followed for two years following completion of the most recent influenza challenge study.
EXCLUSION CRITERIA:
Any condition or event that, in the PI s opinion, may substantially increase the risk associated with study participation or compromise the study s scientific objectives. Conditions that exclude a subject are considered to be unlikely, but an example would include a newly diagnosed medical condition that may alter a participant s immune system and make it unsafe to obtain scheduled blood samples for research purposes.
Principal Investigator
Referral Contact
For more information: