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Flu Vaccine Responses in the Setting of Melanoma Treatment

Primary Purpose

Viral Vaccines

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Inactivated influenza vaccine
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Viral Vaccines focused on measuring Influenza vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adults capable of providing consent
  • have a diagnosis of locally advanced or metastatic melanoma

Exclusion Criteria:

  • are allergic to influenza vaccination
  • have received influenza vaccination within the past 6 months
  • require prednisone, methotrexate, or other immunosuppressing medications
  • have HIV infection
  • have a history of solid organ or bone marrow transplant
  • require combination immunotherapy
  • are on other studies requiring blood draws that might exceed 450 mL total during the period of the influenza vaccine study

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Influenza vaccination cohort

Arm Description

Subjects will receive one dose of seasonal quadrivalent inactivated influenza vaccine intramuscularly for standard of care for prevention of influenza infection.

Outcomes

Primary Outcome Measures

Neutralizing antibody response
The neutralizing antibody titer will be assessed by measurement of the hemagglutinin-inhibition titer before and after influenza vaccination in order to determine the seroconversion rate. The late blood draw may occur between days 21-42 following vaccination.

Secondary Outcome Measures

Full Information

First Posted
October 16, 2017
Last Updated
September 19, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03315975
Brief Title
Flu Vaccine Responses in the Setting of Melanoma Treatment
Official Title
Influenza Vaccine Responses in the Setting of Melanoma Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Influenza vaccination is indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. We are conducting a prospective unblinded study of influenza vaccine recipients.
Detailed Description
Influenza vaccination is indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. In particular, immune responses following influenza vaccination have not been studied in the setting of advanced melanoma and in the context of various anti-tumor treatments. In this study, we will look at the immune response of subjects receiving vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Vaccines
Keywords
Influenza vaccine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Influenza vaccination cohort
Arm Type
Experimental
Arm Description
Subjects will receive one dose of seasonal quadrivalent inactivated influenza vaccine intramuscularly for standard of care for prevention of influenza infection.
Intervention Type
Biological
Intervention Name(s)
Inactivated influenza vaccine
Intervention Description
One dose of quadrivalent inactivated influenza vaccine
Primary Outcome Measure Information:
Title
Neutralizing antibody response
Description
The neutralizing antibody titer will be assessed by measurement of the hemagglutinin-inhibition titer before and after influenza vaccination in order to determine the seroconversion rate. The late blood draw may occur between days 21-42 following vaccination.
Time Frame
21-42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adults capable of providing consent have a diagnosis of locally advanced or metastatic melanoma Exclusion Criteria: are allergic to influenza vaccination have received influenza vaccination within the past 6 months require prednisone, methotrexate, or other immunosuppressing medications have HIV infection have a history of solid organ or bone marrow transplant require combination immunotherapy are on other studies requiring blood draws that might exceed 450 mL total during the period of the influenza vaccine study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E. John Wherry, PhD
Organizational Affiliation
University of Pennsyvlania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Flu Vaccine Responses in the Setting of Melanoma Treatment

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