Immunogenicity of a Trivalent Influenza Vaccine in Patients With Chronic Kidney Disease Undergoing Hemodialysis: MF59-adjuvanted Versus Non-adjuvanted Vaccines
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 174
- 主要终点
- Seroprotection rate (A/H1N1, A/H3N2, B)
研究概览
简要总结
During the 2013-2014 influenza season, CKD patients undergoing HD participated in the study. The patients were randomized into two groups (MF59-adjuvanted vaccine group or non-adjuvanted vaccine group) and were immunized with the respective vaccine. Sera were collected prior to vaccination and at 1and 6 months post vaccination. Levels of hemagglutination inhibition (HI) antibodies were measured.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic kidney disease patients undergoing hemodialysis
- •Who have given written informed consent at the time of enrollment
排除标准
- •Recipients of influenza vaccine of 2013-2014 season before the study
- •History of egg allergy
结局指标
主要结局
Seroprotection rate (A/H1N1, A/H3N2, B)
时间窗: 1 month after vaccination
the proportion of participants with a HI titer level of ≥1:40
Seroconversion rate (A/H1N1, A/H3N2, B)
时间窗: Change of titer from pre-vaccination to 1 month after vaccination
the percentage of subjects with either a pre-vaccination HI titer ≥1:10 and a ≥4-fold increase in 1 month after vaccination HI antibody titer from pre-vaccination or pre-vaccination HI titer \<1:10 and a 1 month after vaccination HI titer of ≥1:40
GMT fold change (A/H1N1, A/H3N2, B)
时间窗: Change of GMT from pre-vaccination to 1 month after vaccination
GMT ratio of the 1 month after vaccination titer to pre-vaccination titer
次要结局
- Seroprotection rate (A/H1N1, A/H3N2, B)(6 months after vaccination)
- Seroconversion rate (A/H1N1, A/H3N2, B)(Change of titer from pre-vaccination to 6 months after vaccination)
- GMT fold change (A/H1N1, A/H3N2, B)(Change of GMT from pre-vaccination to 6 months after vaccination)
研究者
Hee Jin Cheong
MD, PhD
Korea University Guro Hospital