A Multinational, Phase 2, Randomised, Adaptive Protocol to Evaluate Immunogenicity and Reactogenicity of Different COVID-19 Vaccines Administration in Older Adults (≥75) Already Vaccinated Against SARS-COV-2 (EU-COVAT-1_AGED)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 323
- 试验地点
- 9
- 主要终点
- Antibody Titre Increase 14 Days After Study Vaccination Dose.
研究概览
简要总结
This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2.
Part A of this trial foresees testing of different vaccines as a 3rd vaccination dose (first booster) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 wild-type and variants in the elderly, a usually neglected population.
Part B of this trial foresees testing of different vaccines as a 4th vaccination dose (second booster) for comparative assessment of their immunogenicity and safety against SARSCoV-2 wild-type and variants in the identical population.
详细描述
Part A of the present trial in which individuals received a 3rd vaccination (first booster) of either BNT162b2 or mRNA-1273 was closed to further recruitment as of January 13, 2022. This was due to a change in vaccination policies, recommending a 3rd vaccination with either BNT162b2 or mRNA-1273. Therefore, Part A was supplanted by Part B that investigated a 4th COVID-19 vaccination and started on 21 Jan 2022.
The initial study protocol started the trial with Part A in which participants were randomized to a 3rd vaccination (first booster) with either BNT162b2 or mRNA-1273:
Subjects who - prior to study entry - received a vaccination series of either BNT162b2 & BNT162b2 or mRNA-1273 & mRNA-1273 or ChAdOx-1-S & ChAdOx-1-S.
For the reasons mentioned above, the study protocol was amended to continue the trial with Part B in which participants were randomized to a 4th vaccination (second booster) with either BNT162b2 or mRNA-1273:
Subjects who - prior to study entry - received a vaccination series of either BNT162b2 & BNT162b2 & BNT162b2 or BNT162b2 & BNT162b2 & mRNA-1273 or mRNA-1273 & mRNA-1273 & mRNA-1273 or mRNA-1273 & mRNA-1273 & BNT162b2 or ChAdOx-1-S & ChAdOx-1-S & BNT162b2 or ChAdOx-1-S & ChAdOx-1-S & mRNA-1273.
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
盲法说明
No blinding is foreseen in this trial.
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BNT162b2 (Part A)
vaccination with BNT162b2 as 3rd vaccination
干预措施: Comirnaty (BTN162b2) (Biological)
mRNA-1273 (Part A)
vaccination with mRNA-1273 as 3rd vaccination
干预措施: Spikevax (mRNA-1273) (Biological)
BNT162b2 (Part B)
vaccination with BNT162b2 as 4th vaccination
干预措施: Comirnaty (BTN162b2) (Biological)
mRNA-1273 (Part B)
vaccination with mRNA-1273 as 4th vaccination
干预措施: Spikevax (mRNA-1273) (Biological)
结局指标
主要结局
Antibody Titre Increase 14 Days After Study Vaccination Dose.
时间窗: From Day 0 until Day 14
Rate of 2-fold antibody titre increase 14 days after 3rd (Part A) or 4th vaccination dose (Part B) measured by qualitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wildtype virus.
次要结局
- Change in Neutralizing Antibody Titre Against Wild-type 14 Days After Study Vaccination Dose(From Day 0 until Day 14)
- Change in Neutralizing Antibody Titre Against Variants of Concern 14 Days After Study Vaccination Dose(From Day 0 until Day 14)
- Antibody Titre Level at 12 Months After a Study Vaccination Dose(From Day 0 until Month 12)
- Neutralizing Antibody Titre Against Wild-type at 12 Months After Study Vaccination Dose(From Day 0 until Month 12)
- Neutralizing Antibody Titre Against Variants of Concern at 12 Months After Study Vaccination Dose(From Day 0 until Month 12)
研究者
Oliver Cornely, MD
Principal Coordinating Investigator
University of Cologne