<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/NCT04504539</url>
  </required_header>
  <id_info>
    <org_study_id>2020-3284-11191</org_study_id>
    <nct_id>NCT04504539</nct_id>
  </id_info>
  <brief_title>Use of mOPV1 in Routine Immunization in Pakistan.</brief_title>
  <acronym>mOPV1</acronym>
  <official_title>Comparison of mOPV1 Schedules for Routine Immunization in Pakistan. A Community Based Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aga Khan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>World Health Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aga Khan University</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>
      Pakistan has uninterrupted circulation of polioviruses and this may threaten the entire&#xD;
      global community. Bivalent OPV (bOPV), which protects against types 1 and 3, is used for&#xD;
      routine immunization. However, type-3 wild poliovirus is on the verge of eradication,&#xD;
      therefore mOPV1 is important to achieve eradication of type-1 poliovirus.&#xD;
&#xD;
      The main rationale of the study is to interrupt WPV1 circulation and stopping the outbreaks&#xD;
      of VDPVs with the help of mOPV1 instead of bOPV2 for routine immunization, which contains&#xD;
      live poliovirus, and will eventually lead to complete eradication and containment of type 1&#xD;
      WPV, vaccine-related (VDPV) and Sabin polioviruses. This study will provide data to National&#xD;
      Immunization Authorities in order to make strategic decisions about their polio vaccination&#xD;
      schedules in anticipation of the potential global bOPV2 to mOPV1 switch and will provide data&#xD;
      on the proposed responses to type 1 poliovirus outbreaks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Wild Polio Virus 1 (WPV1) is the only responsible virus for wild polio cases across the&#xD;
      globe. The world has successfully eradicated wild poliovirus (PV) 2 and 3. Poliomyelitis&#xD;
      eradication has entered its last phase with only three remaining endemic countries, of which&#xD;
      Pakistan is one and has highest number of WPV1 cases in 2019. The main stream strategies by&#xD;
      the Global Polio Eradication Initiative has made the substantial progress towards the&#xD;
      eradication of poliomyelitis ever since the World Health Assembly has sanctioned it as an&#xD;
      emerging global Public Health threat. These strategies focus on high-quality immunization&#xD;
      activities (routine and supplemental) that target children from birth to age 5 years with&#xD;
      oral poliovirus vaccines (OPVs), and maintaining a system for acute flaccid paralysis&#xD;
      surveillance.&#xD;
&#xD;
      Pakistan has uninterrupted circulation of polioviruses and this may threaten the entire&#xD;
      global community and implies impending failure of goal of global eradication. According to&#xD;
      the Polio endgame strategy 2019-2023, Pakistan and Afghanistan are the only countries in&#xD;
      which WPV transmissions continues to be reported. The genetic sampling and environmental&#xD;
      surveillance have revealed that WPV1 has predominantly persisted in Pakistan and Afghanistan&#xD;
      and are closely linked as they constitute one epidemiological block. Bivalent OPV (bOPV),&#xD;
      which protect against types 1 and 3, is used for routine immunization. However, type-3 wild&#xD;
      poliovirus is on the verge of eradication, therefore mOPV1 is important to achieve&#xD;
      eradication of type-1 poliovirus whose appearance has been continually been confirmed by the&#xD;
      genetic and environmental samplings.&#xD;
&#xD;
      The main rationale of the study is to interrupt WPV1 circulation and stopping the outbreaks&#xD;
      of VDPVs with the help of mOPV1 instead of bOPV2 for routine immunization, which contains&#xD;
      live poliovirus, and will eventually lead to complete eradication and containment of type 1&#xD;
      WPV, vaccine-related (VDPV) and Sabin polioviruses. The study rationale is in line with the&#xD;
      Goal 1- Eradication of GPEI. This study will provide data to National Immunization&#xD;
      Authorities in order to make strategic decisions about their polio vaccination schedules in&#xD;
      anticipation of the potential global bOPV2 to mOPV1 switch and will provide data on the&#xD;
      proposed responses to type 1 poliovirus outbreaks.&#xD;
&#xD;
      Research Questions and Main Objectives :&#xD;
&#xD;
      Overall Objectives of the study will be:&#xD;
&#xD;
        -  To assess the serum immunity against type 1,2 and 3 polioviruses achieved with two&#xD;
           different mOPV1 routine immunization schedule (mOPV1+fIPV (fractional dose intradermal&#xD;
           IPV); mOPV1+FIPV (full dose intramuscular IPV))&#xD;
&#xD;
        -  To compare the serum immunity against type 1,2 and 3 polioviruses achieved with two&#xD;
           different mOPV1 routine immunization schedule with bOPV2 routine immunization schedules&#xD;
           (mOPV1+fIPV, mOPV1+FIPV with bOPV2+fIPV, bOPV2+FIPV)&#xD;
&#xD;
        -  To assess the type 2 response after One full dose IPV with mOPV1 and bOPV2 routine&#xD;
           immunization schedule&#xD;
&#xD;
        -  To assess the type 2 response after two fractional doses of IPV with mOPV1 and bOPV2&#xD;
           routine immunization schedule&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">May 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Different regimens of mOPV and bOPV in combination with either fractional IPV (fIPV) or full dose IPV (FIPV) will be used.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The mOPV and bOPV vaccine vials will be masked by the Clinical Trials Unit to look identical. The assessor will only be provided the enrollment ID and will not be aware of the participant's randomization status.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of children with change in antibody titres following vaccination</measure>
    <time_frame>This will be checked in samples taken at birth, 6 weeks post vaccination, 10 weeks, 14 weeks and 18 weeks of age</time_frame>
    <description>The number of children who produce antibodies following vaccination of each of the 4 arms</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">560</enrollment>
  <condition>Oral Polio Vaccine</condition>
  <arm_group>
    <arm_group_label>mOPV with FIPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a single dose of FIPV at 14 weeks of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bOPV with FIPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>bOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a single dose of FIPV at 14 weeks of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mOPV with fIPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a two doses of fIPV at 6 weeks and 14 weeks of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bOPV with fIPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>bOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a two doses of fIPV at 6 weeks and 14 weeks of age.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>mOPV</intervention_name>
    <description>mOPV (monovalent oral polio vaccine) is an oral polio vaccines which consists of only attenuated virus of serotypes 1</description>
    <arm_group_label>mOPV with FIPV</arm_group_label>
    <arm_group_label>mOPV with fIPV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>bOPV</intervention_name>
    <description>bOPV (bivalent oral polio vaccine) is an oral polio vaccines which consists of attenuated virus of serotypes 1and 3</description>
    <arm_group_label>bOPV with FIPV</arm_group_label>
    <arm_group_label>bOPV with fIPV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Full dose IPV</intervention_name>
    <description>FIPV (full dose injectable polio vaccine)</description>
    <arm_group_label>bOPV with FIPV</arm_group_label>
    <arm_group_label>bOPV with fIPV</arm_group_label>
    <arm_group_label>mOPV with FIPV</arm_group_label>
    <arm_group_label>mOPV with fIPV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>fractional IPV</intervention_name>
    <description>fIPV (fractional dose injectable polio vaccine)</description>
    <arm_group_label>bOPV with FIPV</arm_group_label>
    <arm_group_label>bOPV with fIPV</arm_group_label>
    <arm_group_label>mOPV with FIPV</arm_group_label>
    <arm_group_label>mOPV with fIPV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  born healthy with birth weight 2.0 kg or more, with immediate cry.&#xD;
&#xD;
               -  Parents resident of the study areas Not planning to travel away during entire the&#xD;
                  study period (birth-154 days; birth - 22 weeks) for 3 months at the time of&#xD;
                  enrolment&#xD;
&#xD;
               -  Parent/guardian provides informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of blood testing and cord blood testing&#xD;
&#xD;
               -  Receipt of OPV after birth before eligibility screen&#xD;
&#xD;
               -  Newborns with certain medical conditions i.e., syndromic infants, neonate with&#xD;
                  petechial or purpura (contraindication of intramuscular injections)&#xD;
&#xD;
               -  A confirmed diagnosis of immunodeficiency disorder in a blood relative will&#xD;
                  render the newborn ineligible for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ali Saleem</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aga Khan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ali Saleem</last_name>
    <phone>02134930051</phone>
    <phone_ext>4718</phone_ext>
    <email>ali.saleem@aku.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aga Khan University</name>
      <address>
        <city>Karachi</city>
        <zip>74800</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aga Khan University</investigator_affiliation>
    <investigator_full_name>Ali Faisal Saleem</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>mOPV</keyword>
  <keyword>bOPV</keyword>
  <keyword>randomized trial</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04504539
org study id: 2020-3284-11191
nct id: NCT04504539
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pakistan has uninterrupted circulation of polioviruses and this may threaten the entire
      global community. Bivalent OPV (bOPV), which protects against types 1 and 3, is used for
      routine immunization. However, type-3 wild poliovirus is on the verge of eradication,
      therefore mOPV1 is important to achieve eradication of type-1 poliovirus.

      The main rationale of the study is to interrupt WPV1 circulation and stopping the outbreaks
      of VDPVs with the help of mOPV1 instead of bOPV2 for routine immunization, which contains
      live poliovirus, and will eventually lead to complete eradication and containment of type 1
      WPV, vaccine-related (VDPV) and Sabin polioviruses. This study will provide data to National
      Immunization Authorities in order to make strategic decisions about their polio vaccination
      schedules in anticipation of the potential global bOPV2 to mOPV1 switch and will provide data
      on the proposed responses to type 1 poliovirus outbreaks.
Wild Polio Virus 1 (WPV1) is the only responsible virus for wild polio cases across the
      globe. The world has successfully eradicated wild poliovirus (PV) 2 and 3. Poliomyelitis
      eradication has entered its last phase with only three remaining endemic countries, of which
      Pakistan is one and has highest number of WPV1 cases in 2019. The main stream strategies by
      the Global Polio Eradication Initiative has made the substantial progress towards the
      eradication of poliomyelitis ever since the World Health Assembly has sanctioned it as an
      emerging global Public Health threat. These strategies focus on high-quality immunization
      activities (routine and supplemental) that target children from birth to age 5 years with
      oral poliovirus vaccines (OPVs), and maintaining a system for acute flaccid paralysis
      surveillance.

      Pakistan has uninterrupted circulation of polioviruses and this may threaten the entire
      global community and implies impending failure of goal of global eradication. According to
      the Polio endgame strategy 2019-2023, Pakistan and Afghanistan are the only countries in
      which WPV transmissions continues to be reported. The genetic sampling and environmental
      surveillance have revealed that WPV1 has predominantly persisted in Pakistan and Afghanistan
      and are closely linked as they constitute one epidemiological block. Bivalent OPV (bOPV),
      which protect against types 1 and 3, is used for routine immunization. However, type-3 wild
      poliovirus is on the verge of eradication, therefore mOPV1 is important to achieve
      eradication of type-1 poliovirus whose appearance has been continually been confirmed by the
      genetic and environmental samplings.

      The main rationale of the study is to interrupt WPV1 circulation and stopping the outbreaks
      of VDPVs with the help of mOPV1 instead of bOPV2 for routine immunization, which contains
      live poliovirus, and will eventually lead to complete eradication and containment of type 1
      WPV, vaccine-related (VDPV) and Sabin polioviruses. The study rationale is in line with the
      Goal 1- Eradication of GPEI. This study will provide data to National Immunization
      Authorities in order to make strategic decisions about their polio vaccination schedules in
      anticipation of the potential global bOPV2 to mOPV1 switch and will provide data on the
      proposed responses to type 1 poliovirus outbreaks.

      Research Questions and Main Objectives :

      Overall Objectives of the study will be:

        -  To assess the serum immunity against type 1,2 and 3 polioviruses achieved with two
           different mOPV1 routine immunization schedule (mOPV1+fIPV (fractional dose intradermal
           IPV); mOPV1+FIPV (full dose intramuscular IPV))

        -  To compare the serum immunity against type 1,2 and 3 polioviruses achieved with two
           different mOPV1 routine immunization schedule with bOPV2 routine immunization schedules
           (mOPV1+fIPV, mOPV1+FIPV with bOPV2+fIPV, bOPV2+FIPV)

        -  To assess the type 2 response after One full dose IPV with mOPV1 and bOPV2 routine
           immunization schedule

        -  To assess the type 2 response after two fractional doses of IPV with mOPV1 and bOPV2
           routine immunization schedule
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Different regimens of mOPV and bOPV in combination with either fractional IPV (fIPV) or full dose IPV (FIPV) will be used.
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
masking description: The mOPV and bOPV vaccine vials will be masked by the Clinical Trials Unit to look identical. The assessor will only be provided the enrollment ID and will not be aware of the participant's randomization status.
measure: Number of children with change in antibody titres following vaccination
time frame: This will be checked in samples taken at birth, 6 weeks post vaccination, 10 weeks, 14 weeks and 18 weeks of age
description: The number of children who produce antibodies following vaccination of each of the 4 arms
arm group label: mOPV with FIPV
arm group type: Experimental
description: mOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a single dose of FIPV at 14 weeks of age.
arm group label: bOPV with FIPV
arm group type: Experimental
description: bOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a single dose of FIPV at 14 weeks of age.
arm group label: mOPV with fIPV
arm group type: Experimental
description: mOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a two doses of fIPV at 6 weeks and 14 weeks of age.
arm group label: bOPV with fIPV
arm group type: Experimental
description: bOPV vaccine will be given at birth, 6 weeks, 10 weeks and 14 weeks of age along with a two doses of fIPV at 6 weeks and 14 weeks of age.
intervention type: Biological
intervention name: mOPV
description: mOPV (monovalent oral polio vaccine) is an oral polio vaccines which consists of only attenuated virus of serotypes 1
arm group label: mOPV with FIPV
arm group label: mOPV with fIPV
intervention type: Biological
intervention name: bOPV
description: bOPV (bivalent oral polio vaccine) is an oral polio vaccines which consists of attenuated virus of serotypes 1and 3
arm group label: bOPV with FIPV
arm group label: bOPV with fIPV
intervention type: Biological
intervention name: Full dose IPV
description: FIPV (full dose injectable polio vaccine)
arm group label: bOPV with FIPV
arm group label: bOPV with fIPV
arm group label: mOPV with FIPV
arm group label: mOPV with fIPV
intervention type: Biological
intervention name: fractional IPV
description: fIPV (fractional dose injectable polio vaccine)
arm group label: bOPV with FIPV
arm group label: bOPV with fIPV
arm group label: mOPV with FIPV
arm group label: mOPV with fIPV
criteria: 
gender: All
minimum age: N/A
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ali Saleem
role: Principal Investigator
affiliation: Aga Khan University
last name: Ali Saleem
phone: 02134930051
phone ext: 4718
email: ali.saleem@aku.edu
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Aga Khan University
investigator full name: Ali Faisal Saleem
investigator title: Assistant Professor
sharing ipd: No