Oral Polio Vaccine as Potential Protection Against COVID-19: A Cluster-randomised Trial in Guinea-Bissau
试验速览
- 阶段
- 4 期
- 入组人数
- 3,400
- 试验地点
- 1
- 主要终点
- Mortality or infectious disease causing consultation or admission (Composite outcome)
研究概览
简要总结
Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficial non-specific effects, reducing morbidity and mortality from other infections than polio. Such beneficial non-specific effect have been observed for other live vaccines, including measles, smallpox and BCG vaccine. For BCG, the vaccine for which the mechanism has been studied the most, the effects appear to be mediated through the innate immune system. The COVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has now caused over 7.1 million cases and >400,000 deaths worldwide. As everywhere else, it is anticipated that in Africa the older part of the population will be at risk of severe COVID-19. OPV is widely used in Africa, but for children. Both polio and coronavirus are positive-strand RNA viruses, therefore it is likely that they may induce and be affected by common innate immune mechanisms.
In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigators will assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years of age. The trial will have the power to test the hypothesis that OPV reduces the combined risk of morbidity admission or death (composite outcome) by at least 28% over the subsequent 6 months.
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 (Care Provider, Outcomes Assessor)
盲法说明
Participants are cluster randomised to OPV or no vaccine. Information on group assignment is not available to health center staff and staff at the health and demographic surveillance system
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Living in a household which has had a census visit conducted after 1 January in
- •Age above 50.
排除标准
- •Previous adverse events to OPV; Previous documented COVID-19; Acute severe infection.
结局指标
主要结局
Mortality or infectious disease causing consultation or admission (Composite outcome)
时间窗: 6 months
Composite outcome of the first of death, hospitalisation for infection and/or consultation for infection at the health centre
次要结局
- Self-reported morbidity(6 months)
- Suspected COVID-19 infection(6 months)
- Mortality(6 months)
- Hospital admission for infectious disease(6 months)
- Consultations for infectious disease(6 months)