OPV as Potential Protection Against COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Oral Polio Vaccine as Potential Protection Against COVID-19: A Cluster-randomised Trial in Guinea-Bissau

Conditions
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COVID, Poliovirus Vaccine, Oral, Mortality, Morbidity, Non-Specific Effects of Vaccines

Intervention / Treatment
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* Biological: oral polio vaccine + information
* Behavioral: Information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Living in a household which has had a census visit conducted after 1 January in 2017. Age above 50. Exclusion Criteria: Previous adverse events to OPV; Previous documented COVID-19; Acute severe infection.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19 | Biological: oral polio vaccine + information<br>* Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump<br>Behavioral: Information<br>* Advice regarding how to protect oneself from COVID-19<br>|
| Other: Control<br>Information regarding prevention of COVID-19 | Behavioral: Information<br>* Advice regarding how to protect oneself from COVID-19<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality or infectious disease causing consultation or admission (Composite outcome) | Composite outcome of the first of death, hospitalisation for infection and/or consultation for infection at the health centre | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported morbidity | Episodes with self-reported infectious disease morbidity. | 6 months | 
| Suspected COVID-19 infection | Episodes with self-reported infectious disease morbidity suspected to be caused by COVID (three or more of the following: fever, cough, sore thought, extreme fatigue, loss of smell/taste). | 6 months | 
| Mortality | Either of the components of the composite outcome. | 6 months | 
| Hospital admission for infectious disease | Either of the components of the composite outcome included repeated events. | 6 months | 
| Consultations for infectious disease | Either of the components of the composite outcome included repeated events. | 6 months |