Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor

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

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).

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