<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/NCT04423159</url>
  </required_header>
  <id_info>
    <org_study_id>CHOVAXIM</org_study_id>
    <nct_id>NCT04423159</nct_id>
  </id_info>
  <brief_title>Immunological Characteristics of a Population at Risk of Cholera After Oral Cholera Vaccine (CHOVAXIM)</brief_title>
  <acronym>CHOVAXIM</acronym>
  <official_title>Immunogenicity to Cholera Vaccine Within a Population at Risk in Zambia: Mapping the Kinetics of Immune Responses Over Time</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Infectious Disease Research in Zambia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>European and Developing Countries Clinical Trials Partnership (EDCTP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre for Infectious Disease Research in Zambia</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>
      The purpose of the study is to find out if individuals who received first and second dose of&#xD;
      Oral Cholera Vaccine (OCV) in Lukanga Swamps, Central Province of Zambia have developed&#xD;
      protection against future attacks to cholera. The investigators also want to investigate&#xD;
      whether vitamin A deficiency and being HIV positive increases the chances of suffering from&#xD;
      cholera.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cholera is caused by toxigenic strains of Vibrio cholerae O1 and O139 and is characterised by&#xD;
      sudden onset of acute watery diarrhoea that can lead to severe dehydration and ultimately&#xD;
      death if not treated. Zambia, has continued to experience cholera outbreaks in several parts&#xD;
      of the country. In order to curb the disease outbreaks, the World Health Organisation (WHO)&#xD;
      recommended introducing cholera vaccination as a supplementary cholera control measure&#xD;
      together with other prevention and control strategies, in endemic areas as well as in other&#xD;
      places at risk for cholera outbreaks. OCV has recently been introduced to Zambia where a&#xD;
      large population was vaccinated with 1 dose of Shanchol®, and about 6 months later over 70%&#xD;
      individuals traced to receive a second dose.&#xD;
&#xD;
      Considering the annual outbreaks of cholera in Zambia, there is urgent need to determine&#xD;
      whether Shanchol® is able to elicit a sufficient and specific immunological response in&#xD;
      individuals who received OCV in Zambia. This study will also help the investigator understand&#xD;
      whether there are immune response differences based on genetics and may indicate whether some&#xD;
      people may need more vaccine regimens than others.&#xD;
&#xD;
      Objective 1: To profile cholera specific antibody status of a population at risk of cholera&#xD;
      before and after receiving 1st and 2nd dose of shanchol ® oral cholera vaccine (OCV)&#xD;
      Objective 2: To profile and characterize cholera specific B and T lymphocyte phenotypes among&#xD;
      the immunized Zambians Objective 3: Develop and evaluate a non-invasive proxy measure of OCV&#xD;
      immune responses Objective 4: To measure the protective value of immunizing HIV-infected&#xD;
      individuals through measurement of the neutralization capabilities OCV generated antibodies&#xD;
      Objective 5: To assess the impact of ABO blood groups on cholera antibody generation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2016</start_date>
  <completion_date type="Actual">October 31, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2020</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>
    <intervention_model_description>A pre/post-vaccine study involving a cohort of individuals receiving an oral cholera vaccine in response to a cholera outbreak in the Lukanga Swamps.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vibriocidal</measure>
    <time_frame>4 years</time_frame>
    <description>The primary aim of this project is to determine changes in the vibriocidal geometric mean titers at 6, 12, 24, 30, 36, 42 and 48 months (GMT) in participants who receive the second dose of oral cholera vaccine (OCV) at 28 days .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vibriocidal</measure>
    <time_frame>4 years</time_frame>
    <description>Vibriocidal Antibody Response Rates in HIV infected individuals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vibriocidal</measure>
    <time_frame>1 year</time_frame>
    <description>Detection of vibriocidal antibodies in saliva and compare to serum at 1 year post OCV vaccination</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">225</enrollment>
  <condition>Diarrhea Infectious</condition>
  <arm_group>
    <arm_group_label>OCV vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Shanchol 1.5mL to be administered orally. Each dose contains V.cholerae O1 Inaba El Tor Strain, Inaba classical strain, ogawa classical strain and O139 strain. As well as Thiomersal and a buffer</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>OCV Vaccine</intervention_name>
    <description>2 doses of OCV were administered to all enrolled participants 1st dose administered at baseline and second dose administered 28 days post 1st dose.</description>
    <arm_group_label>OCV vaccine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants aged 18-65 years are eligible to participate.&#xD;
&#xD;
          -  Participant is a resident of the study area. Residence was defined as individuals&#xD;
             living in the study area for the past 1 year.&#xD;
&#xD;
          -  Written consent provided by participant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant aged less than 18 years&#xD;
&#xD;
          -  Refuses to consent to participate&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Participant has acute medical illness prior to receipt of oral cholera vaccine&#xD;
             -Participant has a history of hospitalization for cholera in the past one week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Waya clinic</name>
      <address>
        <city>Kabwe</city>
        <state>Central</state>
        <zip>10101</zip>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Zambia</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diarrhea</keyword>
  <keyword>HIV</keyword>
  <keyword>Vaccines</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholera</mesh_term>
    <mesh_term>Dysentery</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT04423159
org study id: CHOVAXIM
nct id: NCT04423159
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to find out if individuals who received first and second dose of
      Oral Cholera Vaccine (OCV) in Lukanga Swamps, Central Province of Zambia have developed
      protection against future attacks to cholera. The investigators also want to investigate
      whether vitamin A deficiency and being HIV positive increases the chances of suffering from
      cholera.
Cholera is caused by toxigenic strains of Vibrio cholerae O1 and O139 and is characterised by
      sudden onset of acute watery diarrhoea that can lead to severe dehydration and ultimately
      death if not treated. Zambia, has continued to experience cholera outbreaks in several parts
      of the country. In order to curb the disease outbreaks, the World Health Organisation (WHO)
      recommended introducing cholera vaccination as a supplementary cholera control measure
      together with other prevention and control strategies, in endemic areas as well as in other
      places at risk for cholera outbreaks. OCV has recently been introduced to Zambia where a
      large population was vaccinated with 1 dose of Shanchol®, and about 6 months later over 70%
      individuals traced to receive a second dose.

      Considering the annual outbreaks of cholera in Zambia, there is urgent need to determine
      whether Shanchol® is able to elicit a sufficient and specific immunological response in
      individuals who received OCV in Zambia. This study will also help the investigator understand
      whether there are immune response differences based on genetics and may indicate whether some
      people may need more vaccine regimens than others.

      Objective 1: To profile cholera specific antibody status of a population at risk of cholera
      before and after receiving 1st and 2nd dose of shanchol ® oral cholera vaccine (OCV)
      Objective 2: To profile and characterize cholera specific B and T lymphocyte phenotypes among
      the immunized Zambians Objective 3: Develop and evaluate a non-invasive proxy measure of OCV
      immune responses Objective 4: To measure the protective value of immunizing HIV-infected
      individuals through measurement of the neutralization capabilities OCV generated antibodies
      Objective 5: To assess the impact of ABO blood groups on cholera antibody generation
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A pre/post-vaccine study involving a cohort of individuals receiving an oral cholera vaccine in response to a cholera outbreak in the Lukanga Swamps.
primary purpose: Prevention
masking: None (Open Label)
measure: Vibriocidal
time frame: 4 years
description: The primary aim of this project is to determine changes in the vibriocidal geometric mean titers at 6, 12, 24, 30, 36, 42 and 48 months (GMT) in participants who receive the second dose of oral cholera vaccine (OCV) at 28 days .
measure: Vibriocidal
time frame: 4 years
description: Vibriocidal Antibody Response Rates in HIV infected individuals
measure: Vibriocidal
time frame: 1 year
description: Detection of vibriocidal antibodies in saliva and compare to serum at 1 year post OCV vaccination
arm group label: OCV vaccine
arm group type: Experimental
description: Shanchol 1.5mL to be administered orally. Each dose contains V.cholerae O1 Inaba El Tor Strain, Inaba classical strain, ogawa classical strain and O139 strain. As well as Thiomersal and a buffer
intervention type: Biological
intervention name: OCV Vaccine
description: 2 doses of OCV were administered to all enrolled participants 1st dose administered at baseline and second dose administered 28 days post 1st dose.
arm group label: OCV vaccine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Zambia
responsible party type: Sponsor
mesh term: Cholera
mesh term: Dysentery
mesh term: Diarrhea
sharing ipd: Yes