COVID-19: Safety and Immunogenicity of a Reduced Dose of the BioNTech/Pfizer BNT162b2 Vaccine in a Healthy Population
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sciensano
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Geometric Mean Titre (GMT) of Binding antibodies to the RBD of SARS-CoV-2 S protein
研究概览
简要总结
This is a randomized phase IV dose-optimization study evaluating the safety and immunogenicity of two doses of COVID-19 mRNA vaccines being authorized in the European Union since December 2020: Vaccine BNT162b2 (Comirnaty®; Pfizer-BioNTech) in healthy adults up to age 55 year. Immunogenicity will be measured 28 days after first and second dose, and day 180 and day 365 after first vaccination of 20 and 30 mcg of BNT162b2. The primary outcome is the level of binding antibodies for RBD 28 days after the second dose.
详细描述
Background: Data from the dose-escalating phase 1 trials from the COVID-19 mRNA vaccines being authorized in the European Union since December 2020, BNT162b2 (Comirnaty®; Pfizer- BioNTech) indicate that for the age group 18-55 years a lower dose of the vaccine can induce the same immune response as the full dose.
Method: This is a randomized multicenter phase IV dose-optimization study evaluating the safety and immunogenicity of demi-doses of a COVID-19 mRNA vaccine being authorized in the European Union since December 2020, BNT162b2 (Comirnaty®; Pfizer- BioNTech) in healthy adults up to age 55 year. The study will be performed in employees of Mensura EDPB at five different sites.
Objectives: The primary outcome is the level of binding antibodies for RBD 28 days after the second dose. Secondary outcomes are safety and reactogenicity after vaccination. The neutralizing antibodies and the cellular immunity 28 days after second dose will be assessed. Humoral and cellular immunity will be measured 180 and 365 days after first dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The research nurse administrating the vaccine is the only one who is not blinded.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Working at Mensura EDPB, not yet vaccinated for COVID19 -
排除标准
- 未提供
研究组 & 干预措施
Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 20 mcg
In this arm participants will receive two doses of Comirnaty BNT162b2 mRNA 20 mcg.
干预措施: immunogenicity after first and second dose (Diagnostic Test)
Comirnaty®; Pfizer-BioNTech BNT162b2 mRNA 30 mcg
In this arm participants will receive two doses of Comirnaty BNT162b2 mRNA 30 mcg.
干预措施: immunogenicity after first and second dose (Diagnostic Test)
结局指标
主要结局
Geometric Mean Titre (GMT) of Binding antibodies to the RBD of SARS-CoV-2 S protein
时间窗: 28 days after second dose
Binding antibodies anti-RBD
次要结局
- GMT of Neutralizing anti-bodies to Wuhan strain and variants(28 days after second dose)
- T cell response to S protein of Wuhan strain and variants and Memory B cell responses to S protein of Wuhan strain and variants(28 days after second dose)
- Humoral and cellulair immunity(365 days after first dose)
- safety and reactogenicity(through study completion, an average of 1 year)
研究者
Maria Goossens
Scientific collaborator
Sciensano