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Flu Vaccine Responses in the Setting of Melanoma Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03315975
Recruitment Status : Enrolling by invitation
First Posted : October 20, 2017
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment Phase
Viral Vaccines Biological: Inactivated influenza vaccine Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Influenza Vaccine Responses in the Setting of Melanoma Treatment
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Flu Flu Shot Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Influenza vaccination cohort
Subjects will receive one dose of seasonal quadrivalent inactivated influenza vaccine intramuscularly for standard of care for prevention of influenza infection.
 Biological: Inactivated influenza vaccine
One dose of quadrivalent inactivated influenza vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Neutralizing antibody response [ Time Frame: 21-42 days ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315975


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: E. John Wherry, PhD University of Pennsyvlania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03315975    
Other Study ID Numbers: 826207
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of Pennsylvania:
Influenza vaccine
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas