OPV as Potential Protection Against COVID-19

Phase 4

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

• Registration Number: NCT04445428
• Lead Sponsor: Bandim Health Project

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Study Start: 2020-07-15
• Primary Completion: 2022-01-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-18
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	oral polio vaccine + information	Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19
Control	Information	Information regarding prevention of COVID-19
Intervention	Information	Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19

Primary Outcome Measures

Name	Time	Method
Mortality or infectious disease causing consultation or admission (Composite outcome)	6 months	Composite outcome of the first of death, hospitalisation for infection and/or consultation for infection at the health centre

Secondary Outcome Measures

Name	Time	Method
Self-reported morbidity	6 months	Episodes with self-reported infectious disease morbidity.
Suspected COVID-19 infection	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).
Mortality	6 months	Either of the components of the composite outcome.
Hospital admission for infectious disease	6 months	Either of the components of the composite outcome included repeated events.
Consultations for infectious disease	6 months	Either of the components of the composite outcome included repeated events.

Trial Locations

Locations (1)

Bandim Health Project; 🇬🇼 Bissau, Guinea-Bissau