OPV as Potential Protection Against COVID-19

NCT04445428 | Unknown Phase 4

• 1 other identifier: 77/CNES/INASA/2020
• Study Type: interventional
• Target: 3,400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Self-reported morbidity

  6 months

• Suspected COVID-19 infection

  6 months

• Mortality

  6 months

• Hospital admission for infectious disease

  6 months

• Consultations for infectious disease

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Biological: oral polio vaccine + information; Behavioral: Information

Control

OTHER

Information regarding prevention of COVID-19

Behavioral: Information

Interventions

oral polio vaccine + information BIOLOGICAL

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

Intervention

Information BEHAVIORAL

Advice regarding how to protect oneself from COVID-19

Control; Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living in a household which has had a census visit conducted after 1 January in 2017. Age above 50.

You may not qualify if:

• Previous adverse events to OPV; Previous documented COVID-19; Acute severe infection.

Sponsors & Collaborators

• Bandim Health Project: lead

Study Sites (1)

Bandim Health Project

Bissau, Guinea-Bissau

Location

MeSH Terms

Interventions

Poliovirus Vaccine, Oral

Intervention Hierarchy (Ancestors)

Poliovirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Ane Fisker, MD, PhD

  Bandim Health Project

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: July 15, 2020
• Primary Completion: January 31, 2022
• Study Completion: May 1, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)