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Clinical Trials/NCT04445428
NCT04445428
Unknown
Phase 4

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

Bandim Health Project1 site in 1 country3,400 target enrollmentJuly 15, 2020

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Poliovirus Vaccine, Oral
Sponsor
Bandim Health Project
Enrollment
3400
Locations
1
Primary Endpoint
Mortality or infectious disease causing consultation or admission (Composite outcome)
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2020
End Date
May 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Living in a household which has had a census visit conducted after 1 January in
  • Age above 50.

Exclusion Criteria

  • Previous adverse events to OPV; Previous documented COVID-19; Acute severe infection.

Outcomes

Primary Outcomes

Mortality or infectious disease causing consultation or admission (Composite outcome)

Time Frame: 6 months

Composite outcome of the first of death, hospitalisation for infection and/or consultation for infection at the health centre

Secondary Outcomes

  • 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)

Study Sites (1)

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