COVID, Morbidity, Mortality, Non-Specific Effects of Vaccines, Poliovirus Vaccine, Oral
Conditions
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.
Interventions
BIOLOGICALoral polio vaccine + information
Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump
BEHAVIORALInformation
Advice regarding how to protect oneself from COVID-19
Sponsors
Bandim Health Project
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, 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
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Guinea-Bissau
Contacts
PRINCIPAL_INVESTIGATORAne Fisker, MD, PhD
Bandim Health Project
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60 Years |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 1286 Participants |
| Sex: Female, Male Male | 1506 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 28 / 1,580 | 38 / 2,146 |
| other Total, other adverse events | 0 / 1,580 | 0 / 2,146 |
| serious Total, serious adverse events | 0 / 1,580 | 0 / 2,146 |
Outcome results
None listed