Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-05-30

Brief Summary

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

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Detailed Description

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* 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).

Conditions

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Influenza Solid Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Double center prospective case-control clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Immune checkpoint inhibitor

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

Group Type EXPERIMENTAL

Influenza vaccination

Intervention Type BIOLOGICAL

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

Cytotoxic chemotherapy

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

Group Type ACTIVE_COMPARATOR

Influenza vaccination

Intervention Type BIOLOGICAL

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

Interventions

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Influenza vaccination

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Solid cancer patients receiving immune checkpoint inhibitor or cytotoxic chemotherapeutic agent in Seoul National University Hospital or Seoul National University Bundang Hospital.
* Patients who was not vaccinated for influenza in 2018-2019 season
* ECOG performance status 0 or 1
* Patients who fulfilling following laboratory criteria Total bilirubin ≤ 1.5 x upper normal limit Aspartate transaminase, alanine transaminase ≤ 2.5 x upper normal limit Alkaline phosphatase ≤ 2.5 x upper normal limit Creatinine ≤ upper normal limit
* Patients who can understand and agreed with the informed consents.

Exclusion Criteria

* Patients having contraindication for influenza vaccination (e.g. egg allergy)
* Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect)
* Patients with HIV infection
* Patients with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine
* Patients who have transplanted organ and receive immunosuppressants
* Patients who are suspected to have active infection (e.g. pneumonia)
* Patients who receive targeted chemotherapeutic agent alone for cancer treatment
* Patients who could not receive cancer chemotherapy due to hematologic abnormality at the date of the participation

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No