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

NCT05108818 | Recruiting Phase 4 FDA Drug

• 4 other identifiers: 84939821-003375N93021C00015Institutional Funds
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (1)

• Effect of year of birth on neutralizing antibody titers elicited by influenza vaccination

  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.

  7 years

Secondary Outcomes (6)

• Changes in serum HAI antibodies in individuals of different birth years following influenza vaccination

  7 years

• Differences in levels of HA stalk-binding antibodies in individuals of different birth years following influenza vaccination

  7 years

• Differences in levels of NA-binding antibodies in individuals of different birth years following influenza vaccination

  7 years

• Assessment of the frequency of circulating T follicular helper cell response to influenza vaccination in individuals of different birth years

  7 years

• Assessment of the functionality of circulating T follicular helper cell response to influenza vaccination in individuals of different birth years

  7 years

Study Arms (1)

Influenza vaccination

EXPERIMENTAL

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.

Biological: Seasonal influenza vaccine

Interventions

Seasonal influenza vaccine BIOLOGICAL

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

Influenza vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for all study visits
• Aged 18 years and older
• In good health based on self-reported medical conditions via an online survey

You may not qualify if:

• Known allergic reactions to components of the study vaccine
• Known latex allergy
• History of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines
• History of GBS within 6 weeks of receipt of a previous influenza vaccine
• 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
• Treatment with immunoglobulin or another blood product within the 3 months prior to enrollment in this study
• 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)
• Long-term (greater than 2 weeks) usage of oral or parenteral steroids, or high-dose inhaled steroids
• Administration of an influenza vaccine within 2 months prior to enrollment
• 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
• 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
• Intends to donate blood during the study period
• 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
• Pregnancy
• Known human immunodeficiency virus, hepatitis B, or hepatitis C infection

Sponsors & Collaborators

• Stanford University: collaborator
• University of Pennsylvania: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• The Scripps Research Institute: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Scott Hensley, PhD

CONTACT

215-573-3756; hensley@pennmedicine.upenn.edu

Elizabeth Drapeau, PhD

CONTACT

215-573-3756; elizabeth.troisi@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 5, 2021
• Study Start: October 7, 2021
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At publication
• Access Criteria: Per journal publication policy

Locations

US (1)