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

Active, not recruiting
Poliovirus Vaccine, Oral
COVID
Mortality
Morbidity
Non-specific Effects of Vaccines

Biological: oral polio vaccine + information

Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump

Behavioral: Information

Advice regarding how to protect oneself from COVID-19

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 50 Years ~ Maximum: N/A
Countries
Guinea-Bissau
Locations

Bandim Health Project
Bissau, Guinea-Bissau

Ane Fisker, MD, PhD, Principal Investigator
Bandim Health Project

Bandim Health Project
NCT Number