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NCT05108818 | RECRUITING | Influenza, Human

Characterization of Humoral and Cellular Immune Responses Elicited by Influenza Vaccination in Healthy Adults
Sponsor:

University of Pennsylvania

Brief Summary:

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.

Condition or disease

Influenza, Human

Intervention/treatment

Seasonal influenza vaccine

Phase

PHASE4

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 700 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : Characterization of Humoral and Cellular Immune Responses Elicited by Influenza Vaccination in Healthy Adults
Actual Study Start Date : 2021-10-07
Estimated Primary Completion Date : 2027-04-01
Estimated Study Completion Date : 2028-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • 1. Provision of signed and dated informed consent form
  • 2. Stated willingness to comply with all study procedures and availability for all study visits
  • 3. Aged 18 years and older
  • 4. In good health based on self-reported medical conditions via an online survey
Exclusion Criteria
  • 1. Known allergic reactions to components of the study vaccine
  • 2. Known latex allergy
  • 3. History of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines
  • 4. History of GBS within 6 weeks of receipt of a previous influenza vaccine
  • 5. 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
  • 6. Treatment with immunoglobulin or another blood product within the 3 months prior to enrollment in this study
  • 7. Active 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)
  • 8. Long-term (greater than 2 weeks) usage of oral or parenteral steroids, or high-dose inhaled steroids
  • 9. Administration of an influenza vaccine within 2 months prior to enrollment
  • 10. Known acute or chronic medical condition that, in the opinion of the investigator or appropriate sub-investigator, would render vaccination unsafe or would interfere with the evaluation of responses
  • 11. Participation in a study that involves an experimental agent or having received an experimental agent (other than a COVID-19 vaccine) within 1 month prior to enrollment or expecting to receive another experimental agent during the study period
  • 12. Intends to donate blood during the study period
  • 13. 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
  • 14. Pregnancy
  • 15. Known human immunodeficiency virus, hepatitis B, or hepatitis C infection
  • 16. Any condition that the principal investigator believes may interfere with successful completion of the study
Characterization of Humoral and Cellular Immune Responses Elicited by Influenza Vaccination in Healthy Adults

Location Details

NCT05108818

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Locations

RECRUITING

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104