RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-07

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05108818

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Scott Hensley, PhD

CONTACT

215-573-3756

hensley@pennmedicine.upenn.edu

Elizabeth Drapeau, PhD

CONTACT

215-573-3756

elizabeth.troisi@pennmedicine.upenn.edu

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-07

Study Completion Date2027-04

Study Record Updates

Study Start Date2021-10-07

Study Completion Date2027-04

Terms related to this study

Additional Relevant MeSH Terms

Influenza, Human