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Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor

Primary Purpose

Influenza, Solid Carcinoma

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Influenza vaccination

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, vaccine, solid carcinoma, immune checkpoint, efficacy, safety

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immune checkpoint inhibitor

Cytotoxic chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Seroprotection rate

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

Secondary Outcome Measures

Seroconversion rate

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

Geometric mean titer of HI

Geometric mean titers of HI (haemagglutination inhibition) after vaccination

Injection-related adverse events

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

Immune-related adverse events

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

T-cell mediated immune response

The levels of intracellular cytokines measured by flow cytometry

Full Information

NCT ID

NCT03590808

First Posted

July 10, 2018

Last Updated

September 17, 2019

Sponsor

Seoul National University Hospital

Collaborators

Green Cross Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03590808

Brief Title

Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

December 21, 2018 (Actual)

Study Completion Date

May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

Green Cross Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Solid Carcinoma

Keywords

Influenza, vaccine, solid carcinoma, immune checkpoint, efficacy, safety

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Double center prospective case-control clinical trial

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

143 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immune checkpoint inhibitor

Arm Type

Experimental

Arm Description

Arm Title

Cytotoxic chemotherapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Influenza vaccination

Intervention Description

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

Primary Outcome Measure Information:

Title

Seroprotection rate

Description

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

Time Frame

21 to 35 days after vaccination

Secondary Outcome Measure Information:

Title

Seroconversion rate

Description

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

Time Frame

21 to 35 days after vaccination

Title

Geometric mean titer of HI

Description

Geometric mean titers of HI (haemagglutination inhibition) after vaccination

Time Frame

21 to 35 days after vaccination

Title

Injection-related adverse events

Description

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

Time Frame

21 to 35 days after vaccination

Title

Immune-related adverse events

Description

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

Time Frame

6 months after vaccination

Title

T-cell mediated immune response

Description

The levels of intracellular cytokines measured by flow cytometry

Time Frame

21 to 35 days after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wan Beom Park, M.D., PhD.

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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.

Citations:

PubMed Identifier

29320654

Citation

Postow MA, Sidlow R, Hellmann MD. Immune-Related Adverse Events Associated with Immune Checkpoint Blockade. N Engl J Med. 2018 Jan 11;378(2):158-168. doi: 10.1056/NEJMra1703481. No abstract available.

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Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor

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