CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 3,729 enrolled
Drug / intervention
oral polio vaccine + information +1 morebiological
Likely dose
oral polio vaccine + information 0.1 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04445428
NCT04445428Phase 4Completed

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

Bandim Health Project·interventional·Posted Jun 24, 2020·Updated Apr 7, 2026

In Brief

A Phase 4 clinical trial evaluating oral polio vaccine + information and Information for Poliovirus Vaccine, Oral and 4 related conditions. Completed, enrolled 3,729 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGuinea-Bissau
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJun 24, 2020
Enrollment StartJul 15, 2020
Primary CompletionJan 31, 2022
Study CompletionJun 15, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.0 years ago

Interventions

oral polio vaccine + informationbiological

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

Informationbehavioral

Advice regarding how to protect oneself from COVID-19