Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Melanoma

Influenza, Human

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Vaccines

Subjects will receive one dose of seasonal quadrivalent inactivated influenza vaccine intramuscularly for standard of care for prevention of influenza infection.

One dose of quadrivalent inactivated influenza vaccine

Inactivated influenza vaccine

E. John Wherry, PhD

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.

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.

Flu Vaccine Responses in the Setting of Melanoma Treatment

Influenza Vaccine Responses in the Setting of Melanoma Treatment

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.

University of Pennsylvania

Symptoms and General Pathology

Communicable Diseases

Respiratory Tract Infections

Orthomyxoviridae Infections

Virus Diseases

RNA Virus Infections

Respiratory Tract Diseases

FluMist is a live attenuated intranasal influenza vaccine

FluMist

Silvana Carr, MD

Eligible research subjects will be randomized to receive either FluMist or inactivated influenza vaccine then stratified by age and necessity to receive either one or two immunizations. Subjects requiring one immunization will be immunized at Day 0. Subjects requiring two immunizations will be immunized at Day 0 and Day 28. Subjects will be observed for 30 minutes following vaccination and given a diary card to record symptoms after each vaccination.

The secondary objectives of this study are to:

1. Describe the safety of FluMist and inactivated influenza vaccine.
2. Describe the incidence and duration of viral replication following immunization with FluMist.
3. To examine the association between immunization response (seroconversion or seroprotection) and baseline clinical factors (age, type of malignancy, absolute neutrophil count, absolute lymphocyte count, serum IgA, IgG and IgM levels).

A Study of a Live Intranasal Influenza Vaccine in Children With Cancer

A Pilot Study of Flumist, a Live Attenuated Intranasal Influenza Vaccine, and Inactivated Influenza Vaccine in Children With Cancer

To examine the association between immunization response (seroconversion or seroprotection) and baseline clinical factors (age, type of malignancy, absolute neutrophil count, absolute lymphocyte count, serum IgA, IgG and IgM levels).

Describe the safety of FluMist and inactivated influenza vaccine.

Describe the incidence and duration of viral replication following immunization with FluMist.

St. Jude Children's Research Hospital

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Leukemia

Leukemia, Lymphoid

Lymphoma, T-Cell

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Mantle Cell Lymphoma

Follicular Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Immunologic Factors

Patients will be vaccinated with an FDA approved seasonal inactivated influenza vaccine

Given seasonal inactivated influenza vaccine IM

Inactivated Influenza Vaccine

Andres Chang, MD, PhD

Michael Churnetski

Mike Churnetski

Vanessa Smith

This clinical trial evaluates the influenza virus vaccination in evaluating human immune response in patients with lymphoma. Evaluating immune response may increase the understanding of how the immune system changes when patients receive treatment for lymphomas by looking at the antibody levels and the level of the different cells that make up the immune system over time compared to those without lymphoma.

PRIMARY OBJECTIVE:

I. To determine the seroprotection and seroconversion rates after influenza or SARS-CoV2 vaccination in patients with lymphoma receiving active treatment or in follow up observation.

SECONDARY OBJECTIVES:

I. To characterize virus-specific plasmablasts and memory B cells after vaccination in patients with lymphoma receiving active treatment or in follow up observation.

II. To investigate the longevity of viral-specific humoral immunity to influenza virus in patients with lymphoma receiving active treatment or in follow up observation.

III. To assess the timing and strength of the peak immune response to vaccination.

IV. To assess the effect of different lymphomas and treatment modalities in the immune response to vaccination.

OUTLINE:

Patients receive seasonal inactivated influenza vaccine intramuscularly (IM) at day 0.

After completion of study treatment, patients are followed up at days 7, 28, 90, 180, and 365.

Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma

Rates of seroprotection will be calculated for each patient group, and 95% exact binomial confidence intervals will be estimated using the Clopper-Pearson method.

Seroconversion is defined as the percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \> 1:40 or a pre-vaccination HI titer \> 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer (day 0, 28). Rates of seroconversion will be calculated for each patient group, and 95% exact binomial confidence intervals will be estimated using the Clopper-Pearson method.

Assessments will be performed at baseline (time of enrollment), day 7 after first dose of SARS-CoV2 vaccine, day of second dose of vaccine, day 8 after second dose of vaccine, and days 90, 180, and 365.

Assessments will be performed after each dose of SARS-CoV2 booster vaccine.

For serum antibody responses directed against the vaccine epitopes, endpoint IgG titers after vaccination at each time point will be determined.

PBs responses against influenza or SARS-CoV2 will be determined by direct ex vivo enzyme-linked immunospot (ELISPOT). Changes in the PB population will be measured to assess the timing and strength of the peak immune response to vaccination.

The frequency of hemagglutinin (HA)-specific immunoglobulin G (IgG)-secreting MBCs per total IgG-secreting cells after vaccination will be determined. Changes in the MBC population will be measured to assess the timing and strength of the peak immune response to vaccination.

Hemagglutination inhibition assays will be used to assess the timing and strength of the peak immune response to vaccination.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Flu Vaccine Responses in the Setting of Melanoma Treatment	NCT03315975	Viral Vaccines	Inactivated inf...	18 Years -	University of Pennsylvania
A Study of a Live Intranasal Influenza Vaccine in Children With Cancer	NCT00906750	Cancer	FluMist Inactivated inf...	2 Years - 21 Years	St. Jude Children's Research Hospital
A Study of a Live Intranasal Influenza Vaccine in Children With Cancer	NCT00906750	Cancer	FluMist Inactivated inf...	2 Years - 21 Years	St. Jude Children's Research Hospital
Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma	NCT03501576	Chronic Lymphoc... Diffuse Large B... Follicular Lymp... Mantle Cell Lym... Mature T-Cell a...	Inactivated Inf...	18 Years -	Emory University

Spots Global Cancer Trial Database for inactivated influenza vaccine