Flu Infection at UPHS

NCT ID: NCT06807840

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-27
• Study Completion Date: 2026-09-30

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.

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.

Conditions

Influenza Human

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

influenza virus infection

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Aged 18 years and older

4. Influenza positive test result performed within the University of Pennsylvania Health System

Exclusion Criteria

1. Known latex allergy

2. 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

3. Pregnancy due to the volume of blood collected in this study

4. Treatment with immunoglobulin or another blood product within the 3 months prior to enrollment in this study

5. 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)

6. 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

7. Intends to donate blood during the study period

8. A known human immunodeficiency virus, hepatitis B, or hepatitis C infection

9. 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

10. Prolonged inpatient hospitalization that disrupts or interferes with study procedures.

11. Weigh less than 110lbs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Scott Hensley, PhD

Role: CONTACT

hensley@pennmedicine.upenn.edu

215-573-3756

Elizabeth Drapeau, PhD

Role: CONTACT

elizabeth.troisi@pennmedicine.upenn.edu

215-573-3756

Facility Contacts

Tachianna Griffiths

Role: primary

Other Identifiers

75N93021C00015-P00012-9999-1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

857436

Identifier Type: -

Identifier Source: org_study_id