A Phase 4 interventional study of oral polio vaccine + information and Information in Poliovirus Vaccine, Oral, COVID and Mortality, sponsored by Bandim Health Project. Completed at 1 site in Guinea-Bissau. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Bandim Health Project · Phase 4, Interventional, and Prevention
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.
Exclusion Criteria:
Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19
Biological: oral polio vaccine + information · Behavioral: Information
Information regarding prevention of COVID-19
Behavioral: Information
Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump
Advice regarding how to protect oneself from COVID-19
Mortality or Infectious Disease Causing Consultation or Admission (Composite Outcome)
Composite outcome of the first of death, hospitalisation for infection and/or consultation for infection at the health centre
Time frame: 6 months
Self-reported Morbidity
Episodes with self-reported infectious disease morbidity.
Time frame: 6 months
Suspected COVID-19 Infection
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).
Time frame: 6 months
Mortality
Either of the components of the composite outcome.
Time frame: 6 months
Hospital Admission for Infectious Disease
Either of the components of the composite outcome included repeated events.
Time frame: 6 months
Consultations for Infectious Disease
Either of the components of the composite outcome included repeated events.
Time frame: 6 months
| Milestone | Intervention | Control |
|---|---|---|
| Started | 1580 | 2149 |
| Completed | 1580 | 2146 |
| Not completed | 0 | 3 |
Episodes with self-reported infectious disease morbidity.
| events | Intervention | Control |
|---|---|---|
| Self-reported Morbidity | 2724 | 3326 |
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).
| Number of events | Intervention | Control |
|---|---|---|
| Suspected COVID-19 Infection | 162 | 187 |
Either of the components of the composite outcome.
| Participants | Intervention | Control |
|---|---|---|
| Mortality | 28 | 38 |
Either of the components of the composite outcome included repeated events.
| Number of events | Intervention | Control |
|---|---|---|
| Hospital Admission for Infectious Disease | 35 | 62 |
Either of the components of the composite outcome included repeated events.
| Number of events | Intervention | Control |
|---|---|---|
| Consultations for Infectious Disease | 442 | 528 |
Composite outcome of the first of death, hospitalisation for infection and/or consultation for infection at the health centre
| Participants | Intervention | Control |
|---|---|---|
| Mortality or Infectious Disease Causing Consultation or Admission (Composite Outcome) | 169 | 239 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 28/1,580 (1.8%) | 0/1,580 (0%) | 0/1,580 (0%) |
| Control | 38/2,146 (1.8%) | 0/2,146 (0%) | 0/2,146 (0%) |
| Age, Continuous(Years) | Intervention | Control | Total |
|---|---|---|---|
| Median | 59 (54 to 66) | 60 (55 to 66) | 60 (55 to 66) |
| Sex: Female, Male(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Female | 937 | 1286 | 2223 |
| Male | 643 | 863 | 1506 |
| Race and Ethnicity Not Collected(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Race and Ethnicity Not Collected(Participants) | Intervention | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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Plan to share: No — Provided request, data can be made available
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Bandim Health Project