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Recruiting NCT06807840

Flu Infection at UPHS

Observational Influenza Human

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: influenza virus infection.
Who it may be relevant to
Registry conditions: Influenza Human. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluating Immune Imprinting in the Context of Influenza Virus Infections

Overview

Cellular and humoral immune responses in individuals with active influenza infection will be assessed. Each year, up to 50 participants will be enrolled. The investigators hypothesize that influenza infection will elicit mostly memory immune responses rather than de novo immune responses to infection.

Detailed description

Using samples collected from individuals after influenza virus vaccination, the investigators have shown that immune cells primed by previous influenza exposures are recruited to produce antibodies against newer viral strains. The investigators previous work indicate that the majority of the immune cells that respond to influenza vaccination are from the memory compartment, suggesting that 'immune imprinting' greatly affects the specificity of antibodies elicited by influenza vaccines. It remains less clear how prior influenza virus exposures impact immunity elicited by influenza virus infections. Compared to vaccinated individuals, it is more difficult to enroll influenza virus infected patients and track their immune responses over time. Viral antigens can persist for longer amounts of time following influenza virus infections relative to influenza vaccinations. It is therefore possible that influenza virus infections more efficiently prime de novo immune responses compared to influenza virus vaccinations. In this study, the investigators will longitudinally collect serum, PBMC, and respiratory samples from influenza virus-infected individuals from the University of Pennsylvania Health System characterize the cellular and humoral immune responses elicited by influenza virus infections.

Interventions

  • Other influenza virus infection
    Participants with active influenza virus infection will be enrolled in this study.

Primary outcome measures

  • Effect of influenza virus infection on neutralizing antibody titers to contemporary and historical influenza virus strains [Time frame: 2 years]
Secondary outcome measures (3)
  • Differences in binding antibodies against historical and contemporary influenza virus strains in individuals following influenza virus infection [Time frame: 2 years]
  • Characterize B cell responses to influenza following influenza virus infection [Time frame: 2 years]
  • Characterize T cell responses to influenza following influenza virus infection [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Aged 18 years and older
  • Influenza positive test result performed within the University of Pennsylvania Health System

Exclusion criteria

  • Known latex allergy
  • Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months
  • Pregnancy due to the volume of blood collected in this study
  • Treatment with immunoglobulin or another blood product within the 3 months prior to enrollment in this study
  • Any neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy ("active" is defined as having received treatment within the past 5 years)
  • Known acute or chronic medical condition that, in the opinion of the investigator or appropriate sub-investigator, would interfere with the evaluation of immune responses
  • Intends to donate blood during the study period
  • A known human immunodeficiency virus, hepatitis B, or hepatitis C infection
  • Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
  • Prolonged inpatient hospitalization that disrupts or interferes with study procedures.
  • Weigh less than 110lbs

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Penn Presbyterian Medical Center — Philadelphia

Identifiers

NCT: NCT06807840 · 857436 · 75N93021C00015-P00012-9999-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗