SWITCH ON: Analysing the Immunogenicity of Additional Booster Vaccinations in Healthcare Workers. A Multicenter, Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 431
- 试验地点
- 4
- 主要终点
- Is there an increase in antibody levels between day of boost and 28 days after boosting HCW that were initially primed with either the Janssen or an mRNA-based vaccine?
研究概览
简要总结
Eighty percent of the Dutch population has completed a primary COVID-19 vaccination regimen, and 60% of the population received a booster vaccination. Waning immunity, combined with the emergence of antigenically distinct SARS-CoV-2 variants, has led to the consideration of additional booster vaccinations in the Dutch population by autumn 2022. However, despite efforts of the Dutch policymakers, the public's willingness to repeatedly receive COVID-19 booster vaccinations is declining. This is mainly due to a reduced burden of disease by COVID-19, fewer hospitalizations, and fewer deaths. However, population immunity might be one of the major factors responsible for this reduced burden of disease, possibly emphasizing the need for booster vaccinations. In this proposal we will address an important question asked by policymakers: "Are booster vaccinations in autumn recommended for the healthy population?"
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
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give written informed consent for participation in the trial.
- •Adult (male/female) between 18 and 65 years old
- •Sufficient level of the Dutch language to undertake all study requirements
排除标准
- •Adults younger than 18 or older than 65 years.
- •Adults primed with another vaccine than Janssen, Moderna or Pfizer.
- •History of allergic reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the SmPC-listed ingredients of the Janssen/Pfizer/Moderna vaccine).
- •Adults that are pregnant.
- •Currently being treated for cancer.
- •Severe kidney failure or dialyses dependent.
- •Status after organ-, stem cell- or bone marrow transplantation.
- •Use of immunosuppressant's.
- •Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding of bruising following IM injections of vene puncture.
- •Continuous use of anticoagulants, such as coumarins (e.g. acenocoumarol) or novel oral anticoagulants (i.e. apixaban, dabigatran etc).
- •Participants who are currently participating in another research trial.
- •All regular contra-indications of the vaccines will be applied.
研究组 & 干预措施
Direct boost mRNA
Participants will be randomised into a direct boost group (DB; i.e end of August) or a post-poned boost group (PPB; i.e 3-4 months later) group after stratification for priming (mRNA versus Janssen). The immune response will be measured at start of the study (visit 1, all participants) and 0, 7, 28 and 84 days after boost.
干预措施: Direct boost mRNA (Drug)
Direct boost adeno
Participants will be randomised into a direct boost group (DB; i.e end of August) or a post-poned boost group (PPB; i.e 3-4 months later) group after stratification for priming (mRNA versus Janssen). The immune response will be measured at start of the study (visit 1, all participants) and 0, 7, 28 and 84 days after boost.
干预措施: Direct boost adeno (Drug)
Post-poned boost mRNA
Participants will be randomised into a direct boost group (DB; i.e end of August) or a post-poned boost group (PPB; i.e 3-4 months later) group after stratification for priming (mRNA versus Janssen). The immune response will be measured at start of the study (visit 1, all participants) and 0, 7, 28 and 84 days after boost.
干预措施: Post-poned boost mRNA (Drug)
Post-poned boost adeno
Participants will be randomised into a direct boost group (DB; i.e end of August) or a post-poned boost group (PPB; i.e 3-4 months later) group after stratification for priming (mRNA versus Janssen). The immune response will be measured at start of the study (visit 1, all participants) and 0, 7, 28 and 84 days after boost.
干预措施: Post-poned boost adeno (Drug)
结局指标
主要结局
Is there an increase in antibody levels between day of boost and 28 days after boosting HCW that were initially primed with either the Janssen or an mRNA-based vaccine?
时间窗: 28 days
Outcome: Level and fold change of antibodies determined by a quantitative IgG assay comparing the Janssen primed and mRNA-based primed HCW.
Does booster vaccination lead to a rapid secondary recall response, indicative of immunological memory?
时间窗: 28 days
Outcome: Level and fold change of antibodies and T-cell responses determined by a quantitative IgG assay and whole blood IFNγ release assay, respectively, comparing day 7 and 28 post-boost.
次要结局
- What is the breadth of the immune responses after booster vaccination?(28 days)
- What is the predictive value of immune responses on day 7 post boost?(28 days)
- What is the difference in reactogenicity 7 days after boost comparing the Janssen and mRNA primed HCW?(7 days)
- Initial examination of breakthrough infections before and during study period(1 year)
- What is the difference in booster immunogenicity comparing a direct boost with a postponed boost?(28 days)
研究者
Hugo van der Kuy
Head Department Clinical Pharmacy/ Principal Investigator
Erasmus Medical Center