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Phase 4 N=3,729 Randomized Double-blind Prevention

OPV as Potential Protection Against COVID-19

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

Enrolled (actual)
3,729
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Mortality or Infectious Disease Causing Consultation or Admission (Composite Outcome) — 169; 239 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
oral polio vaccine + information (Biological); Information (Behavioral)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
Bandim Health Project
Primary completion
Jan 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Mortality or Infectious Disease Causing Consultation or Admission (Composite Outcome)
169; 239
SECONDARY
Self-reported Morbidity
2724; 3326
SECONDARY
Suspected COVID-19 Infection
162; 187
SECONDARY
Mortality
28; 38
SECONDARY
Hospital Admission for Infectious Disease
35; 62
SECONDARY
Consultations for Infectious Disease
442; 528

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04445428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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