Flu Vaccine Responses in the Setting of Melanoma Treatment

Phase 4

Active, not recruiting

• Conditions: Viral Vaccines
• Interventions: Biological: Inactivated influenza vaccine

• Registration Number: NCT03315975
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-10-16
• Study Start: 2017-10-20
• Study First Posted: 2017-10-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Influenza vaccination cohort	Inactivated influenza vaccine	Subjects will receive one dose of seasonal quadrivalent inactivated influenza vaccine intramuscularly for standard of care for prevention of influenza infection.

Primary Outcome Measures

Name	Time	Method
Neutralizing antibody response	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States