NCT03590808已完成不适用
Efficacy and Safety of Influenza Vaccine in Cancer Patients Receiving Immune Checkpoint Inhibitor
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- Seroprotection rate
研究概览
简要总结
The purpose of this study is to elucidate efficacy and safety of influenza vaccine in cancer patients receiving immune checkpoint inhibitor.
详细描述
- 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Immune checkpoint inhibitor
Experimental
Solid cancer patients who receiving immune checkpoint inhibitor patients
will be undergone "Influenza vaccination" using purified inactivated influenza virus antigen (Green Cross Corp.) 0.5 mL IM once
干预措施: Influenza vaccination (Biological)
Cytotoxic chemotherapy
Active Comparator
Solid cancer patients who receiving conventional cytotoxic chemotherapy
will be undergone "Influenza vaccination" using purified inactivated influenza virus antigen (Green Cross Corp.) 0.5 mL IM once
干预措施: Influenza vaccination (Biological)
结局指标
主要结局
Seroprotection rate
时间窗: 21 to 35 days after vaccination
The percentage of vaccine recipients with a serum haemagglutination inhibition(HI) titre ≥40 post vaccination (21-28 days)
次要结局
- Seroconversion rate(21 to 35 days after vaccination)
- Geometric mean titer of HI(21 to 35 days after vaccination)
- Injection-related adverse events(21 to 35 days after vaccination)
- T-cell mediated immune response(21 to 35 days after vaccination)
- Immune-related adverse events(6 months after vaccination)
研究者
Wan Beom Park
Professor
Seoul National University Hospital
研究点 (2)
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