University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Location contact
Elizabeth Drapeau, PhD
CONTACT
Scott Hensley, PhD
CONTACT
Scott Hensley, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05108818
Cellular and humoral immune responses before and after seasonal influenza vaccination will be assessed. Each year, up to 100 participants will be enrolled. To study age-specific differences in immune responses, participants with various years of birth will be enrolled. The investigators hypothesize that humans with different birth years will mount antibody and cellular responses of different specificities following seasonal influenza vaccination.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Elizabeth Drapeau, PhD
CONTACT
Scott Hensley, PhD
CONTACT
Scott Hensley, PhD
PRINCIPAL_INVESTIGATOR
The investigators and others have shown that the first influenza virus someone is exposed to leaves an immunological imprint that affects antibody responses to antigenically related influenza strains later in life. Year of birth can be used to predict influenza virus exposures during the first years of life. It is possible that immune responses to influenza vaccination later in life differ between people with different birth years, depending on what virus someone was "imprinted" with. This could result in birth year differences in antibody responses upon vaccination and vaccine effectiveness. However, the effect of year of birth on the specificity of humoral and cellular immune responses elicited by influenza vaccination has not been studied in depth. In this study, the investigators will measure influenza virus cellular and humoral immune responses in individuals of different birth years before and after influenza vaccination.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The seasonal influenza vaccine is administered intramuscularly at a dose of 15 ug of HA per component, as approved by the FDA.
Time frame: 7 years
Because year of birth can be used to predict the influenza viruses circulating during the first years of life, assessing antibody responses in individuals of different birth years is one way of determining how prior exposure affects immune responses to seasonal influenza vaccination and infection. The investigators will assess how antibody responses to seasonal influenza vaccination differ in individuals across multiple age groups. Baseline serum neutralizing antibodies to post-vaccination serum neutralizing antibodies against the influenza A (H1N1 and H3N2) and influenza B viral strains that are included in the quadrivalent influenza vaccine will be compared. The investigators will compare neutralizing antibody titers between groups of individuals with different birth years. Neutralizing antibody titers against the vaccine strains will be quantified by focus reduction neutralization test (FRNT) and data will be expressed as FRNT titer.
Time frame: 7 years
Baseline serum antibodies will be compared to those collected after vaccination to access changes in serum hemagglutination inhibition (HAI) antibodies that block virus binding to cells. Titer will be defined as the highest dilution resulting in complete inhibition of hemagglutination in the assay. The changes measured in HAI titer between pre and post vaccination will be compared among individuals of different birth years.
Time frame: 7 years
Baseline serum antibodies will be compared to post-vaccination serum antibodies to assess differences in levels (increase or decrease) of reactive antibodies to the HA stalk of influenza viruses. Serum antibody titers will be measured by ELISA using "headless" HA to quantify serum antibodies targeting the HA stalk. Antibody titers measured in pre and post vaccination sera will be compared among individuals of different birth years. Data will be expressed as ELISA relative units.
Time frame: 7 years
Baseline serum antibodies will be compared to post-vaccination serum antibodies to assess changes in levels (increase or decrease) of antibodies that inhibit NA activity (NA-binding antibodies) of different influenza viruses. NA activity will be measured via an enzyme-linked lectin assay (ELLA) and the amount of serum antibody present that inhibits NA activity of different influenza strains will be quantified. These titers measured in pre and post vaccination sera will be compared among individuals of different birth years. Data will be expressed as ELLA titer.
Time frame: 7 years
Circulating T follicular helper cells (cTfh) with be assessed among peripheral blood mononuclear cells (PBMCs) collected at baseline and after vaccination. Frequencies, defined by percent increase or decrease, will be measured by flow cytometry-based assays. Measurement of the frequencies of cTfh in response to influenza vaccination will be compared among individuals of different birth years to determine the effect of year of birth on cTfh responses following influenza vaccination.
Time frame: 7 years
Circulating T follicular helper cells (cTfh) with be assessed among peripheral blood mononuclear cells (PBMCs) collected at baseline and after vaccination. Functionality, defined by expression of specific cellular markers, will be measured by flow cytometry-based assays. Measurement of the functionality of cTfh in response to influenza vaccination will be compared among individuals of different birth years to determine the effect of year of birth on cTfh responses following influenza vaccination.
Time frame: 7 years
B cells will be assessed among PBMCs collected at baseline and after vaccination. Frequencies, defined by percent increase or decrease, and clonal expansion will be measured by flow cytometry-based and high-throughput DNA sequencing assays. These metrics will be compared among individuals of different birth years to determine the effect of year of birth on B cells responses following influenza vaccination.
Contact information is provided by the study sponsor or research team.
Elizabeth Drapeau, PhD
CONTACT
Scott Hensley, PhD
CONTACT
University of Pennsylvania
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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