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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
143
Purified inactivated influenza virus antigen (Green Cross Corp) 0.5 mL once IM
Seoul National University Hospital
Seoul, South Korea
Seroprotection rate
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
Seroconversion rate
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
Geometric mean titer of HI
Geometric mean titers of HI (haemagglutination inhibition) after vaccination
Time frame: 21 to 35 days after vaccination
Injection-related adverse events
The proportion of patients who experienced local or systemic adverse events related to vaccination
Time frame: 21 to 35 days after vaccination
Immune-related adverse events
The proportion of patients who experienced immune checkpoint inhibitor induced immune-related adverse events
Time frame: 6 months after vaccination
T-cell mediated immune response
The levels of intracellular cytokines measured by flow cytometry
Time frame: 21 to 35 days after vaccination
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