Viral Vaccines
Conditions
Keywords
Influenza vaccine
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.
Interventions
BIOLOGICALInactivated influenza vaccine
One dose of quadrivalent inactivated influenza vaccine
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed