Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor
- Conditions
- Solid CarcinomaInfluenza
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 143
- 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.
- 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
- 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
Seoul National University Hospital🇰🇷Seoul, Korea, Republic of