COVID Vaccine for Indirect Protection: A Cluster Randomized Controlled Trial in Hutterite Colonies
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- RT-PCR confirmed COVID-19 among non-vaccinated Hutterite colony members
研究概览
简要总结
The primary objective of this study is to test whether vaccinating adults ≥18 years in Hutterite colonies with mRNA-1273 (Moderna COVID-19) vaccine as compared to control (usual care) can prevent RT-PCR confirmed COVID-19 in non-vaccinated Hutterite members.
详细描述
Despite the efficacy that has been demonstrated in Phase III randomized controls trials of mRNA COVID-19 vaccines, a critical question that remains unanswered is whether mRNA vaccines lead to herd immunity. The rationale for conducting this study is to learn whether vaccinating adults with a COVID-19 vaccine will prevent COVID-19 infections in non-vaccinated community members. Hutterite communities are unique since they are isolated from towns and cities and also share a number of communal activities, such as eating meals and attending church. Because of their location and practices, the Hutterite colonies give an opportunity to see whether vaccinating some Hutterite members with the COVID vaccine provides protection to the whole group. If the study shows that immunizing some of the population reduces the level of COVID-19 infection for other members of the population, this may be very important in stopping the COVID-19 pandemic and future pandemics.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals under the age of 18
- •Individuals with a contraindication to study vaccines
- •Those not willing to be vaccinated but consent to follow up
排除标准
- •There are no exclusion criteria for this category of participants:
- •Group B: Adults aged 18 years or older, who will be vaccinated as part of the intervention.
- •Exclusion Criteria:
- •Anaphylactic reaction to any component of the study vaccine or to a previous dose of the study vaccines
- •Pregnancy
结局指标
主要结局
RT-PCR confirmed COVID-19 among non-vaccinated Hutterite colony members
时间窗: 12 week period starting after first dose
RT-PCR confirmed from nasal swabs
次要结局
- Signs and symptoms of lower respiratory infection and pneumonia(12 week period starting after first dose)
- School or work-related absenteeism(12 week period starting after first dose)
- RT-PCR confirmed COVID-19 among all Hutterite colony members(12 week period starting after first dose)
- COVID-19 antibody testing(Baseline and through study completion, estimated at 4 months)
- RT-PCR confirmed COVID-19 in high-risk participants(12 week period starting after first dose)
- Intensive care admission(12 week period starting after first dose)
- Mechanical ventilation(12 week period starting after first dose)
- Acute respiratory illness(12 week period starting after first dose)
- Physician visits for respiratory illness(12 week period starting after first dose)
- Death(12 week period starting after first dose)