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OPV as Potential Protection Against COVID-19

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ClinicalTrials.gov Identifier: NCT04445428
Recruitment Status : Enrolling by invitation
First Posted : June 24, 2020
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Poliovirus Vaccine, Oral COVID Mortality Morbidity Non-Specific Effects of Vaccines Biological: oral polio vaccine + information Behavioral: Information Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: 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
Primary Purpose: Prevention
Official Title: Oral Polio Vaccine as Potential Protection Against COVID-19: A Cluster-randomised Trial in Guinea-Bissau
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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

Control
Information regarding prevention of COVID-19
Behavioral: Information
Advice regarding how to protect oneself from COVID-19




Primary Outcome Measures :
  1. Mortality or infectious disease causing consultation or admission (Composite outcome) [ Time Frame: 6 months ]
    Composite outcome of the first of death, hospitalisation for infection and/or consultation for infection at the health centre


Secondary Outcome Measures :
  1. Self-reported morbidity [ Time Frame: 6 months ]
    Episodes with self-reported infectious disease morbidity.

  2. Suspected COVID-19 infection [ Time Frame: 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).

  3. Mortality [ Time Frame: 6 months ]
    Either of the components of the composite outcome.

  4. Hospital admission for infectious disease [ Time Frame: 6 months ]
    Either of the components of the composite outcome included repeated events.

  5. Consultations for infectious disease [ Time Frame: 6 months ]
    Either of the components of the composite outcome included repeated events.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445428


Locations
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Guinea-Bissau
Bandim Health Project
Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
Investigators
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Principal Investigator: Ane Fisker, MD, PhD Bandim Health Project
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Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT04445428    
Other Study ID Numbers: 77/CNES/INASA/2020
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Provided request, data can be made available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No