Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor

Seoul National University

Status: Completed

Conditions: Influenza; Solid Carcinoma

Treatments: Biological: Influenza vaccination

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03590808

1806-088-951

Details and patient eligibility

About

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

Full 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).

Enrollment: 143 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

143 participants in 2 patient groups

Immune checkpoint inhibitor

Experimental group

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

Treatment:

Biological: Influenza vaccination

Cytotoxic chemotherapy

Active Comparator group

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

Treatment:

Biological: Influenza vaccination