Flu Vaccine Responses in the Setting of Melanoma Treatment

Viral Vaccines Clinical Trial

Official title:

Influenza Vaccine Responses in the Setting of Melanoma Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03315975
• Other study ID #: 826207
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 20, 2017
• Est. completion date: July 1, 2024

Study information

• Verified date: September 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Viral Vaccines

Intervention

Biological:
• Inactivated influenza vaccine
One dose of quadrivalent inactivated influenza vaccine

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neutralizing antibody response	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.	21-42 days