Poliovirus Vaccine, OralPhase 4NCT04445428
OPV as Potential Protection Against COVID-19
A Phase 4 study testing oral polio vaccine + information and Information in people with Poliovirus Vaccine, Oral and COVID, run by Bandim Health Project at 1 site in Guinea-Bissau.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Poliovirus Vaccine, Oral, COVID, Mortality
- What is being tested?
- oral polio vaccine + information and Information
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,729 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- 15 Jul 2020to 15 Jun 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living in a household which has had a census visit conducted after 1 January in 2017. Age above 50.
Who cannot join
- Previous adverse events to OPV; Previous documented COVID-19; Acute severe infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Polio Vaccine as Potential Protection Against COVID-19: A Cluster-randomised Trial in Guinea-Bissau
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.
- Being tested
- oral polio vaccine + information, Information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral polio vaccine + informationBiological
Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump
InformationBehavioural
Advice regarding how to protect oneself from COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19 Receives: Biological: oral polio vaccine + information; Behavioral: Information |
| Control | Other | Information regarding prevention of COVID-19 Receives: Behavioral: Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (5)
Self-reported Morbidity
Episodes with self-reported infectious disease morbidity.
Measured: 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).
Measured: 6 months
Mortality
Either of the components of the composite outcome.
Measured: 6 months
Hospital Admission for Infectious Disease
Either of the components of the composite outcome included repeated events.
Measured: 6 months
Consultations for Infectious Disease
Either of the components of the composite outcome included repeated events.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start15 Jul 2020
- Primary completion31 Jan 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Poliovirus Vaccine, OralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 3,729 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ane Fisker, MD, PhD, Principal investigator, Bandim Health Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445428
- Sponsor's protocol ID
- 77/CNES/INASA/2020
- Status last verified
- Feb 2026
- First submitted
- 22 Jun 2020
- Last updated
- 7 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Provided request, data can be made available
Publications
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.
PubMed 36193229
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Polio Vaccine as Potential Protection Against COVID-19: A Cluster-randomised Trial in Guinea-Bissau
- ClinicalTrials.gov ID
- NCT04445428
- Acronym / sponsor ID
- 77/CNES/INASA/2020
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,729 participants (actual)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 24 Jun 2020 (actual)
- Results
- Posted 7 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Biological: oral polio vaccine + information, Behavioral: InformationStandard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19 |
| Control | Other | Behavioral: InformationInformation regarding prevention of COVID-19 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Living in a household which has had a census visit conducted after 1 January in 2017. Age above 50.
Key exclusion criteria (1 listed)
- Previous adverse events to OPV; Previous documented COVID-19; Acute severe infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral polio vaccine + informationBivalent OPV (GSK), 0.1 ml administered orally on a sugar lump | Biological | Intervention |
| InformationAdvice regarding how to protect oneself from COVID-19 | Behavioural | Control, Intervention |
Primary outcome
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
5 secondary outcomes
Self-reported Morbidity
Time frame: 6 months
Suspected COVID-19 Infection
Time frame: 6 months
Mortality
Time frame: 6 months
Hospital Admission for Infectious Disease
Time frame: 6 months
Consultations for Infectious Disease
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36193229Fisker 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.
- Individual participant dataSharing planned: No. Provided request, data can be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ane Fisker, MD, PhD principal investigator
Bandim Health Project
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral polio vaccine + information and Information in people with Poliovirus Vaccine, Oral and COVID, run by Bandim Health Project at 1 site in Guinea-Bissau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea-Bissau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality or Infectious Disease Causing Consultation or Admission (Composite Outcome) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04445428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.