Comparison of Different BNT162b2 and ChAdOx1-S COVID-19 Vaccination Intervals and Combinations on Reactogenicity and Humoral Immunogenicity in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,206
- 试验地点
- 1
- 主要终点
- Difference between the four cohorts regarding the antibody of the viral spike protein 4 weeks after second vaccination
研究概览
简要总结
Investigation of the reactogenicity and immunogenicity of homologous and heterologous vaccine combinations with regard to the formation of SARS-CoV-2 antispike antibodies in health care workers after basic immunization and boost vaccination
详细描述
The basic immunizations (first and second vaccination) were performed from January to June 2021 using the m-RNA vaccine BNT162b2 (BioNTech/Pfizer, B)9 and the vector-based vaccine ChAdOx1-S (AstraZeneca, A). BNT162b2 was used to boost vaccine all study population. The time interval between the basic immunisation and the boost vaccination varied.
Four vaccine-groups could be distinguished:
Group 1 received BNT162b2 with the second vaccination 3 weeks after the first vaccination.
Vaccinees of groups 2 and 3 received AZD1222/ChAdOx1-S as first vaccination and could choose after 12 weeks whether second vaccination with BNT162b2 or AZD1222/ChAdOx1-S should be carried out. This results in homologous (first: AZD1222/ChAdOx1-S, second: AZD1222/ChAdOx1-S) and heterologous (first: AZD1222/ChAdOx1-S, second: BNT162b2) vaccine combinations.
Group 4 received BNT162b2 with the second vaccination 6 weeks after first vaccination.
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
- 是
入选标准
- •hospital staff who received COVID-19 vaccination
排除标准
- •lack of a written informed consent
研究组 & 干预措施
ChAdOx1/BNT162b2 - 12 wks
hospital staff receiving AstraZeneca as prime vaccination and receiving BioNTech as boost vaccination after 12 weeks
干预措施: IM injection of vaccination (vector based vaccination) (Drug)
BNT162b2/BNT162b2 - 6 wks
hospital staff receiving BioNTech as prime vaccination and also receiving BioNTech after 6 weeks as boost vaccination
干预措施: IM injection of vaccination (mRNA vaccination) (Drug)
BNT162b2/BNT162b2 - 3 wks
hospital staff receiving BioNTech as prime vaccination and also receiving BioNTech after 3 weeks as boost vaccination
干预措施: IM injection of vaccination (mRNA vaccination) (Drug)
ChAdOx1/ChAdOx1 - 12 wks
hospital staff receiving AstraZeneca as prime vaccination and also receiving AstraZeneca as boost vaccination after 12 weeks
干预措施: IM injection of vaccination (vector based vaccination) (Drug)
ChAdOx1/BNT162b2 - 12 wks
hospital staff receiving AstraZeneca as prime vaccination and receiving BioNTech as boost vaccination after 12 weeks
干预措施: IM injection of vaccination (mRNA vaccination) (Drug)
结局指标
主要结局
Difference between the four cohorts regarding the antibody of the viral spike protein 4 weeks after second vaccination
时间窗: 4 weeks after second vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.
Difference between the four cohorts regarding the antibody of the viral spike protein 3 months after second vaccination
时间窗: 3 months after second vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.
Difference between the four cohorts regarding the antibody of the viral spike protein 4 weeks after boost vaccination
时间窗: 4 weeks after boost vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.
Difference between the four cohorts regarding the antibody of the viral spike protein 3 months after boost vaccination
时间窗: 3 months after boost vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.
Difference between the four cohorts regarding the antibody of the viral spike protein 6 months after second vaccination
时间窗: 6 months after second vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.
Difference between the four cohorts regarding the antibody of the viral spike protein directly before boost vaccination
时间窗: directly before boost vaccination
The descriptive data are described by frequencies (%/n) and the continuous data by corresponding position parameters (median, interquartile range). The confirmatory analysis is performed using the Wilcoxon or Kruskal-Wallis test. The Bonferroni correction is applied accordingly.
次要结局
- Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the second vaccination?(immediately after second vaccination)
- Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the boost vaccination?(immediately after third (boost) vaccination)
- Do the four cohorts differ in terms of reactogenicity (systemic and/or local vaccine reactions) after the first vaccination?(immediately after first vaccination)
- Are there differences within the cohorts regarding vaccination reactions in subjects with a known allergy?(immediately after second vaccination)
- Differences between the 4 groups after second vaccination regarding a. the individual local vaccination reactions? b. the individual systemic vaccination reactions? c. the number or percentage of vaccination reactions?(immediately after second vaccination)
- Differences between the 4 groups after first vaccination regarding a. the individual local vaccination reactions? b. the individual systemic vaccination reactions? c. the number or percentage of vaccination reactions?(immediately after first vaccination)
- Differences between the 4 groups after boost vaccination regarding a. the individual local vaccination reactions? b. the individual systemic vaccination reactions? c. the number or percentage of vaccination reactions?(immediately after boost vaccination)
- Is there a difference between the four cohorts regarding the use of medication due to vaccination reactions?(first and second vaccination)
- Do the four cohorts differ with regard to the need for a certificate of incapacity for work due to vaccination reactions?(immediately after boost vaccination)
- Are there differences regarding the job groups and the vaccination week days?(immediately after boost vaccination)
- Is there a difference between the four cohorts regarding the severity of vaccination reactions?(immediately after boost vaccination)
- Do the four cohorts differ with respect to the temporal occurrence of vaccination reactions?(immediately after second vaccination)
- Are there differences within the total population regarding vaccination reactions in subjects with a known allergy?(immediately after second vaccination)
- Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at three months from baseline between the four cohorts?(3 months after second vaccination)
- Is there a correlation within cohorts or within the overall population at four weeks regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?(4 weeks after second vaccination)
- Do the variables listed above have an influence on the level of antibody?(3 months after boost vaccination)
- Is there a correlation within cohorts or within the overall population at 3 months regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?(3 months after second vaccination)
- Is there a correlation within cohorts or within the overall population at 6 months regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?(6 months after second vaccination)
- Is there a correlation within cohorts or within the overall population directly before the boost regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?(directly before boost vaccination)
- Is there a correlation within cohorts or within the overall population at 4 weeks after boost regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?(4 weeks after boost vaccination)
- Is there a correlation within cohorts or within the overall population at 3 months after boost regarding the level of antibody and the a. Extent of vaccine response (local, systemic, local & systemic, none)? b. Gender? c. Age? d. BMI?(3 months after boost vaccination)
- Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at three months from baseline within the four cohorts?(3 months after second vaccination)
- Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at six months from baseline within the four cohorts?(6 months after second vaccination)
- Is there a statistically significant or clinically relevant difference between the (drop in) antibodies at six months from baseline between the four cohorts?(6 months after second vaccination)
- Are there any subjects within the study follow-up period who had proven SARS Cov2 infection? (Comparison between groups)(until end of study)
- Is there a correlation within the overall population between the level of antibody and detected SARS Cov2 infection?(3 months and 6 months after second vaccination, directly before boost vaccination and 4 weeks and 3 months after boost vaccination)
研究者
Serge Thal
Clinical Professor, Head of anaesthesiology
University of Witten/Herdecke