Flu Vaccine Responses in the Setting of Melanoma Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-20

Study Completion Date

2026-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Viral Vaccines

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Influenza vaccination cohort

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

Group Type EXPERIMENTAL

Inactivated influenza vaccine

Intervention Type BIOLOGICAL

One dose of quadrivalent inactivated influenza vaccine

Interventions

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Inactivated influenza vaccine

One dose of quadrivalent inactivated influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No