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

NCT ID: NCT05108818

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-07
• Study Completion Date: 2028-03-31

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.

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.

Conditions

Influenza, Human

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Influenza vaccination

Adults will receive a seasonal, inactivated, quadrivalent influenza vaccine administered intramuscularly at a dose of 15 ug of HA per component, as approved by the FDA.

Group Type: EXPERIMENTAL

Seasonal influenza vaccine

Intervention Type: BIOLOGICAL

The seasonal influenza vaccine is administered intramuscularly at a dose of 15 ug of HA per component, as approved by the FDA.

Interventions

Seasonal influenza vaccine

The seasonal influenza vaccine is administered intramuscularly at a dose of 15 ug of HA per component, as approved by the FDA.

Intervention Type: BIOLOGICAL

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

The Scripps Research Institute

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Scott Hensley, PhD

Role: CONTACT

Phone: 215-573-3756

Email: hensley@pennmedicine.upenn.edu

Elizabeth Drapeau, PhD

Role: CONTACT

Phone: 215-573-3756

Email: elizabeth.troisi@pennmedicine.upenn.edu

Facility Contacts

Elizabeth Drapeau, PhD

Role: primary

Scott Hensley, PhD

Role: backup

Other Identifiers

21-0033

Identifier Type: OTHER

Identifier Source: secondary_id

75N93021C00015

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Institutional Funds

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

849398

Identifier Type: -

Identifier Source: org_study_id