OPV as Potential Protection Against COVID-19

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04445428
• Other study ID #: 77/CNES/INASA/2020
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 15, 2020
• Est. completion date: May 2022

Study information

• Verified date: March 2022
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3400
• Est. completion date: May 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Guinea-Bissau	Bandim Health Project	Bissau

Sponsors (1)

Lead Sponsor	Collaborator
Bandim Health Project

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Self-reported morbidity	Episodes with self-reported infectious disease morbidity.	6 months
Secondary	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
Secondary	Mortality	Either of the components of the composite outcome.	6 months
Secondary	Hospital admission for infectious disease	Either of the components of the composite outcome included repeated events.	6 months
Secondary	Consultations for infectious disease	Either of the components of the composite outcome included repeated events.	6 months