Flu Vaccine Responses in the Setting of Melanoma Treatment

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)

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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