<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04445428</url>
  </required_header>
  <id_info>
    <org_study_id>77/CNES/INASA/2020</org_study_id>
    <nct_id>NCT04445428</nct_id>
  </id_info>
  <brief_title>OPV as Potential Protection Against COVID-19</brief_title>
  <official_title>Oral Polio Vaccine as Potential Protection Against COVID-19: A Cluster-randomised Trial in Guinea-Bissau</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bandim Health Project</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bandim Health Project</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficial&#xD;
      non-specific effects, reducing morbidity and mortality from other infections than polio. Such&#xD;
      beneficial non-specific effect have been observed for other live vaccines, including measles,&#xD;
      smallpox and BCG vaccine. For BCG, the vaccine for which the mechanism has been studied the&#xD;
      most, the effects appear to be mediated through the innate immune system. The COVID-19&#xD;
      pandemic caused by the novel coronavirus SARS-CoV-2 has now caused over 7.1 million cases and&#xD;
      &gt;400,000 deaths worldwide. As everywhere else, it is anticipated that in Africa the older&#xD;
      part of the population will be at risk of severe COVID-19. OPV is widely used in Africa, but&#xD;
      for children. Both polio and coronavirus are positive-strand RNA viruses, therefore it is&#xD;
      likely that they may induce and be affected by common innate immune mechanisms.&#xD;
&#xD;
      In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigators will&#xD;
      assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years of age. The&#xD;
      trial will have the power to test the hypothesis that OPV reduces the combined risk of&#xD;
      morbidity admission or death (composite outcome) by at least 28% over the subsequent 6&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">May 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
    <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</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality or infectious disease causing consultation or admission (Composite outcome)</measure>
    <time_frame>6 months</time_frame>
    <description>Composite outcome of the first of death, hospitalisation for infection and/or consultation for infection at the health centre</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported morbidity</measure>
    <time_frame>6 months</time_frame>
    <description>Episodes with self-reported infectious disease morbidity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suspected COVID-19 infection</measure>
    <time_frame>6 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>6 months</time_frame>
    <description>Either of the components of the composite outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital admission for infectious disease</measure>
    <time_frame>6 months</time_frame>
    <description>Either of the components of the composite outcome included repeated events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consultations for infectious disease</measure>
    <time_frame>6 months</time_frame>
    <description>Either of the components of the composite outcome included repeated events.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">3400</enrollment>
  <condition>Poliovirus Vaccine, Oral</condition>
  <condition>COVID</condition>
  <condition>Mortality</condition>
  <condition>Morbidity</condition>
  <condition>Non-Specific Effects of Vaccines</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Information regarding prevention of COVID-19</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>oral polio vaccine + information</intervention_name>
    <description>Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Information</intervention_name>
    <description>Advice regarding how to protect oneself from COVID-19</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Living in a household which has had a census visit conducted after 1 January in 2017.&#xD;
             Age above 50.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous adverse events to OPV; Previous documented COVID-19; Acute severe infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ane Fisker, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bandim Health Project</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bandim Health Project</name>
      <address>
        <city>Bissau</city>
        <country>Guinea-Bissau</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Guinea-Bissau</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>March 16, 2022</last_update_submitted>
  <last_update_submitted_qc>March 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Provided request, data can be made available</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 16, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT04445428/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04445428
org study id: 77/CNES/INASA/2020
nct id: NCT04445428
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
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
measure: Mortality or infectious disease causing consultation or admission (Composite outcome)
time frame: 6 months
description: Composite outcome of the first of death, hospitalisation for infection and/or consultation for infection at the health centre
measure: Self-reported morbidity
time frame: 6 months
description: Episodes with self-reported infectious disease morbidity.
measure: Suspected COVID-19 infection
time frame: 6 months
description: 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).
measure: Mortality
time frame: 6 months
description: Either of the components of the composite outcome.
measure: Hospital admission for infectious disease
time frame: 6 months
description: Either of the components of the composite outcome included repeated events.
measure: Consultations for infectious disease
time frame: 6 months
description: Either of the components of the composite outcome included repeated events.
arm group label: Intervention
arm group type: Experimental
description: Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19
arm group label: Control
arm group type: Other
description: Information regarding prevention of COVID-19
intervention type: Biological
intervention name: oral polio vaccine + information
description: Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump
arm group label: Intervention
intervention type: Behavioral
intervention name: Information
description: Advice regarding how to protect oneself from COVID-19
arm group label: Control
arm group label: Intervention
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Ane Fisker, MD, PhD
role: Principal Investigator
affiliation: Bandim Health Project
facility: 
country: Guinea-Bissau
responsible party type: Sponsor
sharing ipd: No
ipd description: Provided request, data can be made available
provided document: 