Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19 |
|
| Control | Other | Information regarding prevention of COVID-19 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral polio vaccine + information | Biological | Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Morbidity | Episodes with self-reported infectious disease morbidity. | 6 months |
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ane Fisker, MD, PhD | Bandim Health Project | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bandim Health Project | Bissau | Guinea-Bissau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36193229 | Result | Fisker AB, Martins JSD, Nanque LM, Jensen AM, Ca EJC, Nielsen S, Martins CL, Rodrigues A. Oral Polio Vaccine to Mitigate the Risk of Illness and Mortality During the Coronavirus Disease 2019 Pandemic: A Cluster-Randomized Trial in Guinea-Bissau. Open Forum Infect Dis. 2022 Sep 11;9(9):ofac470. doi: 10.1093/ofid/ofac470. eCollection 2022 Sep. |
Not provided
Not provided
Provided request, data can be made available
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19 |
| FG001 | Control | Information regarding prevention of COVID-19 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19 |
| BG001 | Control | Information regarding prevention of COVID-19 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Self-reported Morbidity | Episodes with self-reported infectious disease morbidity. | Repeated eventes | Posted | Number | events | 6 months |
|
|
6 months
Reported as part of main outcomes
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ane Fisker | Bandim Health Project, University of Southern Denmark | +45 65 50 37 40 | afisker@health.sdu.dk |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2020 | Mar 20, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2021 | Mar 20, 2026 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D011055 | Poliovirus Vaccine, Oral |
| ID | Term |
|---|---|
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
Not provided
Not provided
Not provided
Not provided
Not provided
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
| Information | Behavioral | Advice regarding how to protect oneself from COVID-19 |
|
| 6 months |
| Mortality | Either of the components of the composite outcome. | 6 months |
| Hospital Admission for Infectious Disease | Either of the components of the composite outcome included repeated events. | 6 months |
| Consultations for Infectious Disease | Either of the components of the composite outcome included repeated events. | 6 months |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Participants |
|
|
|
| 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). | Posted | Number | Number of events | 6 months |
|
|
|
|
| Secondary | Mortality | Either of the components of the composite outcome. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Hospital Admission for Infectious Disease | Either of the components of the composite outcome included repeated events. | Posted | Number | Number of events | 6 months |
|
|
|
| Secondary | Consultations for Infectious Disease | Either of the components of the composite outcome included repeated events. | Posted | Number | Number of events | 6 months |
|
|
|
| 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 | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| 28 |
| 1,580 |
| 0 |
| 1,580 |
| 0 |
| 1,580 |
| EG001 | Control | Information regarding prevention of COVID-19 | 38 | 2,146 | 0 | 2,146 | 0 | 2,146 |
Not provided
Not provided
| D045424 |
| Complex Mixtures |