Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination in Patients After Organ Transplantation (DANTE-SIRIO 8) Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- the anti-SARS-CoV-2 IgG antibody concentration 3 months after vaccination cycle with the BNT162b2 vaccine
研究概览
简要总结
Great expectations to control the pandemic are placed in vaccines against COVID-19. Currently, the four COVID-19 vaccines approved in the European Union. The investigators designed a study assessing the anti-SARS-CoV-2 IgG antibody titer after vaccination cycle with the BNT162b2 vaccine in several time points relating these results to the COVID-19 history and severity of symptoms during the disease and after the first and second vaccine dose.
详细描述
The study includes patients of Antoni Jurasz University Hospital No.1 in Bydgoszcz after organ transplantation. To meet the inclusion criteria patients will have to be vaccinated with two doses of the BNT162b2 vaccine. The assessment of the anti-SARS-CoV-2 IgG antibody titer at several time points in each participant. Fresh serum samples were used to measure SARS-CoV-2 IgG on the Siemens Atellica system (Siemens Healthineers, Erlangen, Germany). Results of SARS-CoV-2 IgG were given as U/ml, whereby the cut-off for positivity was defined as ≥1.0 U/ml.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent to study
- •Age ≥ 18 years
- •Receiving two doses of the BNT162b2 vaccine
- •patients post organ transplantation
排除标准
- •patients who did not complete 2-dose vaccination schedule
- •patients who received any other vaccine than BNT162b2
- •patients considered by investigator to be unable to cooperate
结局指标
主要结局
the anti-SARS-CoV-2 IgG antibody concentration 3 months after vaccination cycle with the BNT162b2 vaccine
时间窗: 0-12 months
evaluation of anti-SARS-CoV-2 IgG antibody concentration 3 months after 2-dose vaccination with BNT162b2 vaccine
次要结局
- the anti-SARS-CoV-2 IgG antibody concentration immediately before, 1 and 3 months after the third vaccine dose(0-12 months)
- the anti-SARS-CoV-2 IgG antibody concentration 6, 9 and 12 months after two-dose vaccination cycle(0-12 months)
- confirmed COVID-19 after vaccination(0-12 months)
- local and/or systemic adverse reactions after vaccination(0-12 months)
研究者
Jacek Kubica
Professor
Collegium Medicum w Bydgoszczy