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OPV as Potential Protection Against COVID-19

NCT04445428 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3729

Last updated 2026-04-07

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Bandim Health Project

    lead OTHER

Principal Investigators

  • Ane Fisker, MD, PhD · Bandim Health Project

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2022-01-31
Completion
2022-06-15

Countries

  • Guinea-Bissau

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04445428 on ClinicalTrials.gov