Safety and Immunogenicity of Influenza Vaccine Among HIV-infected Young Subjects: Conventional Vaccine Versus Intradermal Vaccine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 88
- 主要终点
- The proportion of participants with a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of <1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10
研究概览
简要总结
Several studies have shown poor immune response to conventional influenza vaccines in HIV-infected individuals. This study was conducted expecting the more potent immunogenicity of intradermal vaccine compared with conventional intramuscular vaccine in HIV-infected adults.
详细描述
During the 2011/2012 pre-influenza season, three vaccines were used in HIV-infected adults (18 to 60 years): inactivated intramuscular vaccine (Agripal), reduced-content intradermal vaccine (IDflu9μg) and standard-content intradermal vaccine (IDflu15μg). Serum hemagglutination-inhibiting (HI) antibodies and INF-γ ELISpot assay were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded for 7 days.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected individuals who were not immunized with 2011/2012 influenza vaccine
排除标准
- •known allergy to egg
- •presentation of any febrile illness ≥37.5°C on the day of vaccination
- •any history of hypersensitivity reaction to previous influenza vaccination
- •any other vaccinations within the past one month
- •use of immunosuppressive agent
- •recipient of blood product or immunoglobulins during the previous three months
- •any other conditions that might interfere with the study results
结局指标
主要结局
The proportion of participants with a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of <1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10
时间窗: Outcome measure was assessed at two points (baseline and 4 weeks after vaccination)
次要结局
- GMT ratio of the post-vaccination titer to pre-vaccination titer(Outcome measure was assessed at two points (baseline and 4 weeks after vaccination))
- Percentage of subjects with a post-vaccination titer ≥1:40(Outcome measure was assessed 4 weeks after vaccination)
研究者
Hee Jin Cheong
Professor
Korea University Guro Hospital