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OpenTrials
Completed

NCT Number: NCT04445428

OPV as Potential Protection Against COVID-19

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bandim Health Project

Bissau, Guinea-Bissau

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral polio vaccine + information

Biological

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

Information

Behavioral

Advice regarding how to protect oneself from COVID-19

Primary outcomes

  1. 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

  1. Self-reported Morbidity

    Time frame: 6 months

    Episodes with self-reported infectious disease morbidity.

  2. Suspected COVID-19 Infection

    Time frame: 6 months

    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).

  3. Mortality

    Time frame: 6 months

    Either of the components of the composite outcome.

  4. Hospital Admission for Infectious Disease

    Time frame: 6 months

    Either of the components of the composite outcome included repeated events.

  5. Consultations for Infectious Disease

    Time frame: 6 months

    Either of the components of the composite outcome included repeated events.

Sponsors and collaborators

Lead sponsor

Bandim Health Project

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 24, 2020
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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