Flu Infection at UPHS

NCT06807840 | Recruiting

• 2 other identifiers: 85743675N93021C00015-P00012-9999-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza Human

Keywords

Flu Infection at UPHS

Outcome Measures

Primary Outcomes (1)

• Effect of influenza virus infection on neutralizing antibody titers to contemporary and historical influenza virus strains

  The investigators will compare neutralizing antibodies in sera, plasma, and nasal swab samples against the influenza strain that each participant is infected with as well as historical and recently circulating influenza virus strains. Antibody titers between different strains will be compared to understand if memory or de novo immune responses are generated following influenza infection based on inferred influenza exposure history.

  2 years

Secondary Outcomes (3)

• Differences in binding antibodies against historical and contemporary influenza virus strains in individuals following influenza virus infection

  2 years

• Characterize B cell responses to influenza following influenza virus infection

  2 years

• Characterize T cell responses to influenza following influenza virus infection

  2 years

Interventions

influenza virus infection OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 50 influenza virus-infected participants who have tested positive for influenza virus infection within the University of Pennsylvania Health System will be enrolled in the study. Potential candidates will be in the Emergency Department with influenza-like symptoms and will be eligible once the eligibility criteria are met.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Stanford University: collaborator

Study Sites (1)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Scott Hensley, PhD

CONTACT

215-573-3756; hensley@pennmedicine.upenn.edu

Elizabeth Drapeau, PhD

CONTACT

215-573-3756; elizabeth.troisi@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: January 27, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At publication
• Access Criteria: Per journal publication policy

Locations

US (1)