Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor

Not Applicable

Completed

• Conditions: Solid Carcinoma; Influenza
• Interventions: Biological: Influenza vaccination

• Registration Number: NCT03590808
• Lead Sponsor: Seoul National University Hospital

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).

Study Timeline

• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-07-10
• Study First Posted: 2018-07-18
• Study Start: 2018-09-01
• Primary Completion: 2018-12-21
• Study Completion: 2019-05-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immune checkpoint inhibitor	Influenza vaccination	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
Cytotoxic chemotherapy	Influenza vaccination	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

Primary Outcome Measures

Name	Time	Method
Seroprotection rate	21 to 35 days after vaccination	The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days)

Secondary Outcome Measures

Name	Time	Method
Seroconversion rate	21 to 35 days after vaccination	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	21 to 35 days after vaccination	Geometric mean titers of HI (haemagglutination inhibition) after vaccination
Injection-related adverse events	21 to 35 days after vaccination	The proportion of patients who experienced local or systemic adverse events related to vaccination
T-cell mediated immune response	21 to 35 days after vaccination	The levels of intracellular cytokines measured by flow cytometry
Immune-related adverse events	6 months after vaccination	The proportion of patients who experienced immune checkpoint inhibitor induced immune-related adverse events

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of