Flu Infection at UPHS
ConditionInfluenza Human
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
influenza virus infection
Other interventionParticipants with active influenza virus infection will be enrolled in this study.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
2 yearsSecondary outcomes
1
Differences in binding antibodies against historical and contemporary influenza virus strains in individuals following influenza virus infection
The investigators will compare binding 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.
Time frame
2 years2
Characterize B cell responses to influenza following influenza virus infection
Influenza specific B cells will be identified in PBMC samples and their specificity and functionality to different influenza virus strains will be assessed to understand how influenza infection influences the generation of memory and de novo immune responses.
Time frame
2 years3
Characterize T cell responses to influenza following influenza virus infection
T cells specific to influenza will be identified in PBMC samples and their specificity and functionality to different influenza virus strains will be assessed to understand how influenza infection influences the generation of memory and de novo immune responses.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Stanford University
Collaborator
Source ClinicalTrials.gov