2024-511478-56-00招募中4 期
dTap booster vaccination of health care workers (HC dTap)
Varsinais-Suomen hyvinvointialue1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月24日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The percentage of study participants with PT-specific IgG antibody geometric mean concentration (GMC) ≥5 IU/mL 0-7 days pre-vaccination.
研究概览
简要总结
To study pertussis, diphtheria, and tetanus immunity in health care workers before their booster vaccination with dTap vaccine and the immunological response 4 weeks after the booster vaccination.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Working constantly with infants <12 months of age and thus requirement for dTap booster vaccination every 5 years
- •> 4 years from the previous dTap vaccination
- •Compliant with study procedures (2 visits with questionnaires, blood and MLF samples, planning to receive the dTap vaccine)
排除标准
- •Medical exempt not being able to be vaccinated (e.g. severe allergic reaction from some of the components in the vaccine)
结局指标
主要结局
The percentage of study participants with PT-specific IgG antibody geometric mean concentration (GMC) ≥5 IU/mL 0-7 days pre-vaccination.
The percentage of study participants with PT-specific IgG antibody geometric mean concentration (GMC) ≥5 IU/mL 0-7 days pre-vaccination.
次要结局
- PT-specific IgG antibody geometric mean concentration (GMC) 28 days after vaccination.
- The difference in FHA, PRN, and Fimbriae 2/3 IgG antibody GMCs pre- and 28 days post-vaccination.
- Pertussis antigen-specific plasma B-cell frequencies pre- and 28 days post-vaccination measured by ELISpot.
- Pertussis antigen-specific memory B-cell frequencies pre- and 28 days post-vaccination measured by ELISpot.
- Pertussis antigen-specific T-cell responses determined by cytokine analysis either from pertussis antigen stimulated whole blood samples/PBMC’s and/or supernatants.
- Assays measuring pertussis specific functional immunity include: PT neutralization; PT epitope specific antibodies; avidity; adherence inhibition; bactericidal activity; bacterial opsonization and phagocytosis undertaken on serum samples taken pre- and 28 days post-vaccination.
- Tetanus- and diphtheria toxoid-specific IgG antibody GMC measured by ELISA pre- and 28 days post-vaccination.
研究者
Lauri Ivaska
Scientific
Varsinais-Suomen hyvinvointialue
研究点 (1)
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