Clinical trial NCT03590808: Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitor
Official title: Efficacy and Safety of Influenza Vaccine in Cancer Patients Receiving Immune Checkpoint Inhibitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Solid Carcinoma
Keywords: Influenza
vaccine
solid carcinoma
immune checkpoint
efficacy
safety
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Green Cross Corporation
First posted: 2018-07-18
Enrollment: 143
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double center prospective case-control clinical trial
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Seroprotection rate
timeFrame: 21 to 35 days after vaccination
Secondary outcomes:
measure: Seroconversion rate
timeFrame: 21 to 35 days after vaccination
measure: Geometric mean titer of HI
timeFrame: 21 to 35 days after vaccination
measure: Injection-related adverse events
timeFrame: 21 to 35 days after vaccination
measure: Immune-related adverse events
timeFrame: 6 months after vaccination
measure: T-cell mediated immune response
timeFrame: 21 to 35 days after vaccination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Wan Beom Park, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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