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Immune Checkpoint Inhibitors

Vaccines

Solid cancer patients who receiving immune checkpoint inhibitor patients

will be undergone "Influenza vaccination" using purified inactivated influenza virus antigen (Green Cross Corp.) 0.5 mL IM once

Solid cancer patients who receiving conventional cytotoxic chemotherapy

will be undergone "Influenza vaccination" using purified inactivated influenza virus antigen (Green Cross Corp.) 0.5 mL IM once

Purified inactivated influenza virus antigen (Green Cross Corp) 0.5 mL once IM

Influenza vaccination

Wan Beom Park, M.D., PhD.

The purpose of this study is to elucidate efficacy and safety of influenza vaccine in cancer patients receiving immune checkpoint inhibitor.

* Solid cancer patients receiving immune checkpoint inhibitor or cytotoxic chemotherapy will be recruited 1:2 manner in two hospitals. Target numbers are 48 and 95, respectively.
* All the participants will be vaccinated for influenza during their chemotherapy when they meet inclusion criteria.
* All the participants will be asked if they have any contraindication for influenza vaccine by a physician before vaccination.
* Hemagglutination inhibition Ab titre at pre-vaccination and post-vaccination (21-35 days after vaccination) will be examined in all participants to examine seroprotection rates, seroconversion rates, and changes in geometric mean titer.
* And they will be monitored for any vaccination-related adverse reaction or immune-related adverse events after 2-4 days(via phone call), and till 6 months after vaccination (when they visit oncology clinics).

Double center prospective case-control clinical trial

Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor

Efficacy and Safety of Influenza Vaccine in Cancer Patients Receiving Immune Checkpoint Inhibitor

We are not planning to share IPDs publically, but de-identified individual participant data for all outcome measures could be shared with other researchers under their request.

The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days)

Seroconversion rate is defined as the percentage of vaccine recipients with a fourfold increase or more in post-vaccination HI titre

Geometric mean titers of HI (haemagglutination inhibition) after vaccination

The proportion of patients who experienced local or systemic adverse events related to vaccination

The proportion of patients who experienced immune checkpoint inhibitor induced immune-related adverse events

The levels of intracellular cytokines measured by flow cytometry

Green Cross Corporation

Seoul National University Hospital

Professor

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

B-cell Lymphoma

Group A: Trivalent subvirion vaccine - standard inactivated influenza vaccine by intramuscular injection.

Group B: Trivalent rHA0 vaccine 15 μg per rHA0 (total 45 μg rHA0)

Group C: Trivalent rHA0 vaccine 45 μg per rHA0 (total 135 μg rHA0)

Group D: Trivalent rHA0 vaccine 135 μg per rHA0 (total 405 μg rHA0)

Receive either standard inactivated influenza vaccine or one of three doses of the experimental vaccine, vaccine dose 15, 45 or 135 μg HA per virus, intramuscular injection.

Trivalent Baculovirus-expressed Influenza HA vaccine

Amar Safdar, MD

Primary Objective:

To assess the trend in immunogenic response across patients administered either licensed trivalent inactivated influenza vaccine (TIV) or one of three doses (15, 45 or 135 μg) of trivalent recombinant baculovirus expressed hemagglutinin vaccines. Immunogenic response is defined as a 4-fold or greater increase in serum antibody.

Secondary Objective:

To determine the safety and tolerability of 3 doses (15 μg HA per virus, 45 μg HA per virus, and 135 μg HA per virus) of recombinant baculovirus-expressed HA vaccine in patients with non-Hodgkin's B-cell lymphoma.

Influenza is a common respiratory infection caused by viruses. Standard influenza vaccines may not be as effective at protecting cancer patients as the general population from getting influenza. New technology has been developed that allows stronger (and hopefully more effective) influenza vaccines to be developed. This research study will test an experimental influenza vaccine.

If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to receive either standard inactivated influenza vaccine or one of three doses of the experimental vaccine. You will have an equal chance of being assigned to any of the four treatment groups. Neither your physician, the study doctor, or you will know which vaccine or dose you received. In case of an emergency, the study doctor can find out which vaccine and dose you received.

Before the injection is given, a blood test will be taken to measure your antibodies (substances that fight infection). About two teaspoons of blood will be taken for this blood test. The vaccine will be given as a one time injection in the arm. After you are given the injection, you will be observed for 20 minutes in the clinic before you are sent home. Everyone taking part in this study will be asked to keep a symptom diary and temperature log for 1 week after the injection. After 7 days, you will return for review of the diary and any symptoms you may have had.

At 4 and 8 weeks after the influenza vaccine is given, most patients will have a blood test to learn the amount of immunity against the influenza virus they have developed. About two teaspoons of blood will be required for this test. A few patients may not be eligible for the eight week blood collection and will be instructed by the study nurse about future visits to UTMDACC. Six months after you have received the vaccine, you will be contacted by one of the study personnel to ask you if you had any serious side effects that might be from the study vaccine. Once you have received this follow-up telephone call, your participation in this study will be completed.

This is an investigational study. The standard vaccine used in this study is FDA approved and commercially available. The experimental vaccine is authorized for use in research only. About 100 patients will take part in this study. All will be enrolled at UTMDACC.

This protocol is partially funded by a research contract from the National Institutes of Health (NIH) to Baylor College of Medicine.

Influenza Vaccination in Patients Receiving Antineoplastic Therapy for Non-Hodgkin's Lymphoma

Evaluation of the Reactogenicity and Immunogenicity of Different Doses of Trivalent Baculovirus-expressed Influenza HA Vaccine in Adults With Non-Hodgkin's B-cell Lymphoma: A Phase II, Double-Blind Pilot Study - Version 4

National Institutes of Health (NIH)

M.D. Anderson Cancer Center

Lymphoma, Non-Hodgkin

Antirheumatic Agents

Rituximab

Patients who received rituximab last dose 3-6 months before influenza vaccination will be the "early group".

Patients who received rituximab last dose 9-12 months before influenza vaccination will be the "late group".

Healthy individuals will be receive vaccination with influenza vaccine and will serve as controls.

influenza vaccination with influenza vaccine

Minke AE Rab, Drs.

The purpose of this study is to compare the number of responders to vaccination with the influenza virus vaccine at different time points after last dose of rituximab in patients with lymphoma. Secondly to study the immune-response to vaccination with influenza virus vaccine, after treatment with rituximab in relation to the reconstitution of immune-function.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor	NCT03590808	Influenza Solid Carcinoma	Influenza vacci...	20 Years -	Seoul National University Hospital
Influenza Vaccination in Patients Receiving Antineoplastic Therapy for Non-Hodgkin's Lymphoma	NCT00307710	Lymphoma	Trivalent Bacul...	18 Years -	M.D. Anderson Cancer Center
Response to Influenza Vaccination in Lymphoma Patients Treated With Rituximab	NCT01707628	Non-Hodgkin Lym...	influenza vacci...	18 Years -	St. Antonius Hospital

Spots Global Cancer Trial Database for influenza vaccination