Influenza, Solid Carcinoma
Conditions
Keywords
Influenza, vaccine, solid carcinoma, immune checkpoint, efficacy, safety
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).
Interventions
BIOLOGICALInfluenza vaccination
Purified inactivated influenza virus antigen (Green Cross Corp) 0.5 mL once IM
Sponsors
Green Cross Corporation
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Double center prospective case-control clinical trial
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Immune-related adverse events | 6 months after vaccination | The proportion of patients who experienced immune checkpoint inhibitor induced immune-related adverse events |
| T-cell mediated immune response | 21 to 35 days after vaccination | The levels of intracellular cytokines measured by flow cytometry |
Countries
South Korea
Outcome results
None listed