Randomized Controlled Trial to Compare Seroprotection Rate According to Timing of Influenza Vaccination in Adult Patients With Non-Hematologic Malignancies Receiving Scheduled Cytotoxic Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Seroprotection rate
研究概览
简要总结
The purpose of this study is to determine the timing of influenza vaccination to induce higher antibody response in adult patients with non-hematologic malignancies receiving scheduled cytotoxic chemotherapy.
详细描述
The participants will be stratified by the age (cut off; 60 years old) and last year influenza vaccination, and block-randomized to 2 groups; Day 1 vaccination group and Day 11 vaccination group.
Day 1 group will be vaccinated at Day 1, when the cycle of chemotherapy begins. Day 11 group will get the vaccine at Day 11, 10 days after chemotherapy begins.
As the rate of completion of study in the Day 11 group is anticipated lower than Day 1 group, we will assign the participants into Day 1: Day 11 with the different ratio; 4:5.
Hemagglutination inhibition Ab titre at pre-vaccination and post-vaccination (21-28 days after vaccination) will be examined in all participants.
All the participants will be asked if they have any contraindication for influenza vaccine by a physician before vaccination. And they will be monitored for any adverse reaction of the vaccination after 2-4 days(phone calling) and after 21-28 days (visiting the hospital).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Patients who receive the scheduled cytotoxic chemotherapy every 3 weeks because of solid cancer.
- •Specific definition of each term is like following:
- •The solid cancer includes various kinds of cancer except hematologic and lymphoid malignancies.
- •Cytotoxic chemotherapy includes adjuvant, neoadjuvant or palliative purpose of chemotherapy with the planned duration at least over 3 cycles every 3 weeks.
- •Targeted therapy drugs like as monoclonal antibody, tyrosine kinase inhibitor or oral chemotherapy drugs like as Xeloda are excluded.
- •Patients who did not receive the influenza vaccination yet in the current year.
- •Older than 19 years
- •Eastern Cooperative Oncology Group (ECOG) performance status is 0, 1, or 2
- •Cell blood count meets following criteria:
- •Neutrophile count ≥ 1.5 x 10^9/L
- •Platelet count ≥ 100 x 10^9/L
- •Hemoglobin ≥ 8 g/dL
- •Patients who can understand and agreed with the informed consents.
排除标准
- •Patients who have any contraindication for influenza vaccination.
- •Patients who are supposed to receive the last chemotherapy at the enrollment
- •Patients who receive simultaneous radiation therapy with cytotoxic chemotherapy
- •Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect)
- •Patients with HIV and low CD 4+ T cell count (< 500/uL)
- •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 supposed to get prophylactic G-CSF after chemotherapy
- •Patients who are suspected to have active infectious disease.
结局指标
主要结局
Seroprotection rate
时间窗: 21-28 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
- Geometric mean titre of HI(21-28 days after vaccination)
- Seroconversion factor(21-28 days after vaccination)
- Seroconversion rate(21-28 days after vaccination)
- Vaccine-related adverse events(within 28 days)
研究者
Wan Beom Park
Associate Professor
Seoul National University Hospital