OPV as Potential Protection Against COVID-19

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

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 Overview

• Status: Completed
• Conditions: Mortality; COVID; Morbidity; Poliovirus Vaccine, Oral; Non-Specific Effects of Vaccines
• Intervention / Treatment: Biological: oral polio vaccine + information; Behavioral: Information

• Study Type: Interventional
• Enrollment (Actual): 3729
• Phase: Phase 4

Contacts and Locations

Study Locations

• Guinea-Bissau
  • Bissau, Guinea-Bissau
    • Bandim Health Project

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19	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
Other: Control; Information regarding prevention of COVID-19	Behavioral: Information; Advice regarding how to protect oneself from COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Either of the components of the composite outcome.	6 months
Self-reported Morbidity	Episodes with self-reported infectious disease morbidity.	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).	6 months
Hospital Admission for Infectious Disease	Either of the components of the composite outcome included repeated events.	6 months
Consultations for Infectious Disease	Either of the components of the composite outcome included repeated events.	6 months

Collaborators and Investigators

• Sponsor: Bandim Health Project
• Investigators: Principal Investigator: Ane Fisker, MD, PhD, Bandim Health Project

Publications and helpful links

General Publications

• Fisker AB,Martins JSD,Nanque LM,Jensen AM,Ca EJC,Nielsen S,Martins CL,Rodrigues A

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; Poliovirus Vaccines; Poliovirus Vaccine, Oral
• Other Study ID Numbers: 77/CNES/INASA/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Provided request, data can be made available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No