Protocol Details
Long-Term Observation of Hemagglutinin and Neuraminidase Inhibition Antibody Titers After Influenza Challenge
This study is currently recruiting participants.
Summary
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: 120 Years |
Referral Letter Required | Yes |
Population Exclusion(s) | Non-English Speaking;
Children |
Keywords | Natural History;
Longitudinal Observation;
Influenza Like Infection (ILI);
Immunity;
Flu |
Recruitment Keyword(s) | None |
Condition(s) | Post Influenza |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Institute of Allergy and Infectious Diseases |
Background:
- 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 or current or prior participation in an LID natural history 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 and a nasal sample.
- 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 an additional sample taken from the nose.
- Participants will complete a health questionnaire once a month on a secure website. Participants may also give their responses over the telephone.
Eligibility
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.
Citations:
Grohskopf LA, Olsen SJ, Sokolow LZ, Bresee JS, Cox NJ, Broder KR, Karron RA, Walter EB; Centers for Disease Control and Prevention. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP) -- United States, 2014-15 influenza season. MMWR Morb Mortal Wkly Rep. 2014 Aug 15;63(32):691-7. Thompson WW, Weintraub E, Dhankhar P, Cheng PY, Brammer L, Meltzer MI, Bresee JS, Shay DK. Estimates of US influenza-associated deaths made using four different methods. Influenza Other Respir Viruses. 2009 Jan;3(1):37-49. doi: 10.1111/j.1750-2659.2009.00073.x. Cox RJ. Correlates of protection to influenza virus, where do we go from here? Hum Vaccin Immunother. 2013 Feb;9(2):405-8. Epub 2013 Jan 4.
Contacts:
Clinical Trials Number:
NCT02511002