Flu Vaccine Responses in the Setting of Melanoma Treatment

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University of Pennsylvania

Status and phase

Active, not recruiting
Phase 4

Conditions

Viral Vaccines

Treatments

Biological: Inactivated influenza vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT03315975
826207

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Influenza vaccination cohort
Experimental group
Description:
Subjects will receive one dose of seasonal quadrivalent inactivated influenza vaccine intramuscularly for standard of care for prevention of influenza infection.
Treatment:
Biological: Inactivated influenza vaccine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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