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Enrolling by invitationNCT02511002Updated Sep 22, 2026

Long-term Observation of Hemagglutinin and Neuraminidase Inhibition Antibody Titers After Influenza Challenge

An observational study in Post Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 120 Years
Sex
All
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Study summary

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.
Read the detailed description

Circulating anti-influenza antibodies are an important factor in predicting clinical illness and severity in those infected with influenza. Specific antibodies against influenza include proteins targeting hemagglutinin (HA) and neuraminidase (NA). Lifelong immunity does not occur with influenza, either from natural infection or from vaccination. Due to the antigenic variation of Influenza A, individuals may become infected multiple times with the same subtype of influenza and even with the same strain. In the setting of natural infection and vaccination, antibody titer levels can persist initially, but then wane over time.

In our previous challenge studies, measurements of antibody responses have been focused solely on the acute infection period up to 2 months after initial infection. Long-term changes in immunity have not been investigated. The challenge setting gives us the unique ability to follow individuals from a specific, known and well-characterized exposure/illness to measure long-term changes in antibody titers from a pre-exposure baseline. This study could offer unique insight into how anti-influenza antibody titers change over time naturally and in response to other infections and life events. This type of controlled study has never been done and we believe monitoring titers long-term will help us better understand protective correlates of influenza.

In this natural history study, we will follow individuals who have undergone influenza challenge or have been naturally infected with influenza to evaluate changes in anti-influenza antibody titers over a 2-year period. Subjects will be followed for symptoms of influenza-like illness (ILI) and other changes in clinical status through quarterly clinical evaluations with blood draws. Monthly questionnaires will be used to follow subjects in between visits.

02

Conditions studied

  • Post Influenza

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Keywords

  • Natural History
  • Longitudinal Observation
  • Influenza Like Infection (ILI)
  • Immunity
  • Flu
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's planned enrollment of 200 is below the median of 300 across 305 observational studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy volunteers after influenza challenge and patients after natural influenza infection

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.

    1. 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

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)

Groups and cohorts

  • 1

    Post influenza infection

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What researchers measure

Primary outcomes

  1. To characterize the timing of peak antibody response to hemagglutinin (HA) and neuraminidase (NA) post influenza challenge or after natural infection To evaluate the long-term variability of hemagglutinin inhibition (HAI) and neuraminidase inhib...

    Trend of HAI titer over multiple time points Trend of NAI titer over multiple time points

    Time frame: 2 years

Secondary outcomes

  1. To correlate changes in clinical status such as influenza-like illness (ILI) or vaccinations with changes in antibody titers and other immune measures

    Change in HAI titer before and after change in clinical status Change in NAI titer before and after change in clinical status

    Time frame: 2 years

07

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
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References and documents

Publications

  • 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. PubMed 25121712 ↗
  • 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. PubMed 19453440 ↗
  • Cox RJ. Correlates of protection to influenza virus, where do we go from here? Hum Vaccin Immunother. 2013 Feb;9(2):405-8. doi: 10.4161/hv.22908. Epub 2013 Jan 4. PubMed 23291930 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02511002
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Jul 29, 2015
Start date
Jul 17, 2015
Primary completion
May 12, 2027 (estimated)
Completion
May 12, 2027 (estimated)
Last update
Sep 22, 2026

Study contacts

Alison Han, M.D.
principal investigator · National Institute of Allergy and Infectious Diseases (NIAID)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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