<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/NCT03829735</url>
  </required_header>
  <id_info>
    <org_study_id>2017-048</org_study_id>
    <nct_id>NCT03829735</nct_id>
  </id_info>
  <brief_title>Neonatal Vaccination Against Hepatitis B in Africa - Sero-survey in Senegal</brief_title>
  <acronym>NeoVac2S</acronym>
  <official_title>Neonatal Vaccination Against Hepatitis B in Africa - Sero-survey in Senegal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Pasteur</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Pasteur</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>
      Chronic infection with hepatitis B virus (HBV) is a leading cause of death in adults in&#xD;
      sub-Saharan Africa (SSA). Prior to the introduction of the hepatitis B vaccine, main modes of&#xD;
      transmission in SSA were perinatal transmission from mother-to-child (MTCT) (10%) and&#xD;
      horizontal transmission during early childhood (90%). MTCT occurs through contact with&#xD;
      maternal fluids during passage through the birth cana; transplacental transmission and&#xD;
      transmission through breastfeeding are rare.&#xD;
&#xD;
      In 2009, WHO recommended the administration of hepatitis B vaccination to all newborns within&#xD;
      24 hours of birth to prevent perinatal and early transmissions. In Senegal, the government&#xD;
      introduced the monovalent vaccine that can be used within 24 hours after birth in the&#xD;
      Expanded Program on Immunization (EPI) in March 2016.&#xD;
&#xD;
      Here, we present a study protocol for a sero-epidemiological study of pairs of children aged&#xD;
      9 to 12 months and their mothers, identified through the demographic study, to assess the&#xD;
      impact of monovalent vaccine introduced by the national program for prevention of&#xD;
      mother-to-child transmission in Senegal. We will also assess the diagnostic performance of&#xD;
      loop-mediated isothermal amplification assay (LAMP) to identify people with high viral&#xD;
      replication (HBV DNA ≥200,000 IU/ml), compared to a conventional reference test (PCR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic infection with hepatitis B virus (HBV) is a leading cause of death in adults in&#xD;
      sub-Saharan Africa (SSA). Each year, about 61,000 people are estimated to die of&#xD;
      hepatocellular carcinoma (HCC) or cirrhosis secondary to chronic infection with HBV. Prior to&#xD;
      the introduction of the hepatitis B vaccine, main modes of transmission in SSA were perinatal&#xD;
      transmission from mother-to-child (MTCT) (10%) and horizontal transmission during early&#xD;
      childhood (90%). MTCT occurs through contact with maternal fluids during passage through the&#xD;
      birth cana; transplacental transmission and transmission through breastfeeding are rare.&#xD;
&#xD;
      Despite a relatively low frequency of perinatal transmission in SSA, prevention of this type&#xD;
      of transmission is important, because this mode of transmission results in higher risk of&#xD;
      becoming chronic HBV carriers, and developing chronic liver disease, including HCC, than&#xD;
      horizontal transmission.&#xD;
&#xD;
      In 2009, WHO recommended the administration of hepatitis B vaccination to all newborns within&#xD;
      24 hours of birth to prevent perinatal and early transmissions. In Senegal, the government&#xD;
      introduced the monovalent vaccine that can be used within 24 hours after birth in the&#xD;
      Expanded Program on Immunization (EPI) in March 2016.&#xD;
&#xD;
      It is in this context that the NeoVac study started in 2016 in Senegal, Burkina Faso and&#xD;
      Madagascar. The general objective is to develop a long-term strategy adapted to the local&#xD;
      context to vaccinate newborns against hepatitis B in the first 24 hours of life.&#xD;
&#xD;
      The NeoVac 1, a population-based epidemiological survey to estimate the coverage of this&#xD;
      newly introduced monovalent hepatitis B vaccine started in Senegal in 2018. Here, we present&#xD;
      a study protocol for a sero-epidemiological study of pairs of children aged 9 to 12 months&#xD;
      and their mothers, identified through the demographic study, to assess the impact of&#xD;
      monovalent vaccine introduced by the national program for prevention of mother-to-child&#xD;
      transmission in Senegal. We will also assess the diagnostic performance of loop-mediated&#xD;
      isothermal amplification assay (LAMP) to identify people with high viral replication (HBV DNA&#xD;
      ≥200,000 IU/ml), compared to a conventional reference test (PCR).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not started&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 1, 2020</start_date>
  <completion_date type="Actual">August 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vaccination coverage of the vaccine at birth from the health record and health post registers</measure>
    <time_frame>9 to 12 months post-natal visit</time_frame>
    <description>Collection of thedate of vaccination of children aged 9-12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive HBsAg among mothers of children aged 9-12 months</measure>
    <time_frame>9 to 12 months post-natal visit</time_frame>
    <description>HBsAg testing from capillary blood on site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive HBsAg among children aged 9-12 months</measure>
    <time_frame>9 to 12 months post-natal visit</time_frame>
    <description>HBsAg testing from capillary blood on site</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Children and their mothers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Human biological samples from children aged 9 to 12 months and their mothers. Capillary and venous blood samples.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Human biological samples</intervention_name>
    <description>Collection of capillary blood for HbsAg testing. Collection of 12 mL of blood for HbsAg positive women and 1 mL for HbsAg positive children.</description>
    <arm_group_label>Children and their mothers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All mothers of children between 9 and 12 months of age registered in the SSDS of Niakhar,&#xD;
        Bambey and Fatick, who accept a blood sample from her and their child.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A child without a mother identified for sampling&#xD;
&#xD;
          -  Failure to sign informed consent to participate in the NeoVac 2 study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabien Taieb</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Pasteur Dakar</affiliation>
  </overall_official>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>March 8, 2022</last_update_submitted>
  <last_update_submitted_qc>March 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <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/NCT03829735
org study id: 2017-048
nct id: NCT03829735
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic infection with hepatitis B virus (HBV) is a leading cause of death in adults in
      sub-Saharan Africa (SSA). Prior to the introduction of the hepatitis B vaccine, main modes of
      transmission in SSA were perinatal transmission from mother-to-child (MTCT) (10%) and
      horizontal transmission during early childhood (90%). MTCT occurs through contact with
      maternal fluids during passage through the birth cana; transplacental transmission and
      transmission through breastfeeding are rare.

      In 2009, WHO recommended the administration of hepatitis B vaccination to all newborns within
      24 hours of birth to prevent perinatal and early transmissions. In Senegal, the government
      introduced the monovalent vaccine that can be used within 24 hours after birth in the
      Expanded Program on Immunization (EPI) in March 2016.

      Here, we present a study protocol for a sero-epidemiological study of pairs of children aged
      9 to 12 months and their mothers, identified through the demographic study, to assess the
      impact of monovalent vaccine introduced by the national program for prevention of
      mother-to-child transmission in Senegal. We will also assess the diagnostic performance of
      loop-mediated isothermal amplification assay (LAMP) to identify people with high viral
      replication (HBV DNA ≥200,000 IU/ml), compared to a conventional reference test (PCR).
Chronic infection with hepatitis B virus (HBV) is a leading cause of death in adults in
      sub-Saharan Africa (SSA). Each year, about 61,000 people are estimated to die of
      hepatocellular carcinoma (HCC) or cirrhosis secondary to chronic infection with HBV. Prior to
      the introduction of the hepatitis B vaccine, main modes of transmission in SSA were perinatal
      transmission from mother-to-child (MTCT) (10%) and horizontal transmission during early
      childhood (90%). MTCT occurs through contact with maternal fluids during passage through the
      birth cana; transplacental transmission and transmission through breastfeeding are rare.

      Despite a relatively low frequency of perinatal transmission in SSA, prevention of this type
      of transmission is important, because this mode of transmission results in higher risk of
      becoming chronic HBV carriers, and developing chronic liver disease, including HCC, than
      horizontal transmission.

      In 2009, WHO recommended the administration of hepatitis B vaccination to all newborns within
      24 hours of birth to prevent perinatal and early transmissions. In Senegal, the government
      introduced the monovalent vaccine that can be used within 24 hours after birth in the
      Expanded Program on Immunization (EPI) in March 2016.

      It is in this context that the NeoVac study started in 2016 in Senegal, Burkina Faso and
      Madagascar. The general objective is to develop a long-term strategy adapted to the local
      context to vaccinate newborns against hepatitis B in the first 24 hours of life.

      The NeoVac 1, a population-based epidemiological survey to estimate the coverage of this
      newly introduced monovalent hepatitis B vaccine started in Senegal in 2018. Here, we present
      a study protocol for a sero-epidemiological study of pairs of children aged 9 to 12 months
      and their mothers, identified through the demographic study, to assess the impact of
      monovalent vaccine introduced by the national program for prevention of mother-to-child
      transmission in Senegal. We will also assess the diagnostic performance of loop-mediated
      isothermal amplification assay (LAMP) to identify people with high viral replication (HBV DNA
      ≥200,000 IU/ml), compared to a conventional reference test (PCR).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Vaccination coverage of the vaccine at birth from the health record and health post registers
time frame: 9 to 12 months post-natal visit
description: Collection of thedate of vaccination of children aged 9-12 months
measure: Positive HBsAg among mothers of children aged 9-12 months
time frame: 9 to 12 months post-natal visit
description: HBsAg testing from capillary blood on site
measure: Positive HBsAg among children aged 9-12 months
time frame: 9 to 12 months post-natal visit
description: HBsAg testing from capillary blood on site
arm group label: Children and their mothers
arm group type: Experimental
description: Human biological samples from children aged 9 to 12 months and their mothers. Capillary and venous blood samples.
intervention type: Other
intervention name: Human biological samples
description: Collection of capillary blood for HbsAg testing. Collection of 12 mL of blood for HbsAg positive women and 1 mL for HbsAg positive children.
arm group label: Children and their mothers
criteria: 
gender: All
minimum age: 9 Months
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Fabien Taieb
role: Principal Investigator
affiliation: Institut Pasteur Dakar
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis
sharing ipd: No