OPV as Potential Protection Against COVID-19

NCT ID: NCT04445428

Last Updated: 2022-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

3400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-15

Study Completion Date

2022-05-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
Participants are cluster randomised to OPV or no vaccine. Information on group assignment is not available to health center staff and staff at the health and demographic surveillance system

Study Groups

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Intervention

Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19

Group Type EXPERIMENTAL

oral polio vaccine + information

Intervention Type BIOLOGICAL

Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump

Information

Intervention Type BEHAVIORAL

Advice regarding how to protect oneself from COVID-19

Control

Information regarding prevention of COVID-19

Group Type OTHER

Information

Intervention Type BEHAVIORAL

Advice regarding how to protect oneself from COVID-19

Interventions

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oral polio vaccine + information

Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump

Intervention Type BIOLOGICAL

Information

Advice regarding how to protect oneself from COVID-19

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bandim Health Project

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ane Fisker, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Bandim Health Project

Locations

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Bandim Health Project

Bissau, , Guinea-Bissau

Site Status

Countries

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Guinea-Bissau

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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77/CNES/INASA/2020

Identifier Type: -

Identifier Source: org_study_id

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