Study of Immune Responses to Influenza Vaccination

Better understanding of the immune responses to influenza vaccination is needed in order to understand situations of poor vaccine response. Adults will receive influenza vaccination and then have peripheral blood drawn at pre-defined intervals in order to study the lymphocyte responses.

Study Overview

• Status: Recruiting
• Conditions: Influenza Vaccination
• Intervention / Treatment: Biological: Influenza vaccination

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sokratis Apostolidis, MD; Phone Number: 267-584-6653; Email: sokratis.apostolidis@pennmedicine.upenn.edu
• Study Contact Backup: Name: E.John Wherry, PhD; Email: wherry@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Sokratis Apostolidis, MD; Phone Number: 267-584-6653; Email: sokratis.apostolidis@pennmedicine.upenn.edu
      • Principal Investigator: E. John Wherry, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Community-dwelling adults able to provide consent who need influenza vaccination for standard of care

Exclusion Criteria:

• febrile illness at time of vaccination
• active malignancy
• use of immunosuppressing medications
• blood donation in the past 60 days
• influenza vaccinated during the preceding 6 months
• allergic reactions to influenza vaccination

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Influenza vaccination cohort; Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care.	Biological: Influenza vaccination; Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Influenza neutralizing antibody titers	21-42 days

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: E.John Wherry, PhD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2017
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 820590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No