<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/NCT03228069</url>
  </required_header>
  <id_info>
    <org_study_id>1/2017</org_study_id>
    <nct_id>NCT03228069</nct_id>
  </id_info>
  <brief_title>Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in HIV-infected Adults</brief_title>
  <official_title>Humoral and Cell-mediated Immune Responses and Immunological Tolerance After Rabies Booster Vaccination in Previously Rabies Immunized HIV-infected Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Saovabha Memorial Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen Saovabha Memorial Institute</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>
      To study the humoral and cell-mediated immune responses in HIV-infected adults who had&#xD;
      previously received rabies booster vaccination more than a year before&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous study has shown the higher immunogenicity response among HIV-infected adults who&#xD;
      received a single visit 4-site intradermal rabies booster vaccination than those who received&#xD;
      the conventional intramuscular regimen. The investigators follow the persistence of these&#xD;
      effects. Also, the regulatory T cell levels were examined after the rabies booster&#xD;
      vaccination .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The volunteers who participated in the previous clinical trials were invited to join this study. Of which, there were 2 groups, one received a single visit 4-site intradermal rabies booster vaccination. The another received a conventional intramuscular rabies booster vaccination on day 0 and 3.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rabies Neutralizing Antibody Titers (RNab)</measure>
    <time_frame>GMTs of RNab and proportion of volunteers who have had RNab above protective antibody levels (0.5 IU/ml) after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.</time_frame>
    <description>Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rabies specific T cell response</measure>
    <time_frame>Numbers of spots, of which represent the rabies specific T cell response after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.</time_frame>
    <description>Rabies specific T cell response is measured by Enzyme - linked Immunospot Assay (ELISPOT)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rabies specific regulatory T cells</measure>
    <time_frame>Numbers of Rabies specific regulatory T cells after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.</time_frame>
    <description>Rabies specific regulatory T cells is measured by flow cytometry method</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Rabies</condition>
  <arm_group>
    <arm_group_label>single visit 4-site ID vaccination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood would be drawn from those who received a single visit 4-site ID rabies booster vaccination in the previous trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional IM vaccination</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Blood would be drawn from those who received a conventional intramuscular rabies booster vaccination in the previous trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood drawn after rabies booster vaccination</intervention_name>
    <description>Blood would be drawn for testing of rabies neutralizing antibody titers, rabies specific T lymphocytes and regulatory T cells after receipt of rabies booster vaccination at least a year before.</description>
    <arm_group_label>Conventional IM vaccination</arm_group_label>
    <arm_group_label>single visit 4-site ID vaccination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy HIV-infected adults&#xD;
&#xD;
          -  Previously received rabies booster vaccination by participation in the previous&#xD;
             clinical trials of the investigators.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have any active opportunistic infections&#xD;
&#xD;
          -  Received blood or blood product within 3 months&#xD;
&#xD;
          -  Received anti-malarial drugs&#xD;
&#xD;
          -  Received rabies vaccination in a previous year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suda Sibunruang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Saovabha Memorial Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Suda Sibunruang, MD</last_name>
    <phone>+66 2 2520161</phone>
    <phone_ext>125</phone_ext>
    <email>sudapunrin@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Terapong Tantawichien, MD</last_name>
    <phone>+66 2 2520161</phone>
    <phone_ext>132</phone_ext>
    <email>terapong_tantawichien@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Queen Saovabha Memorial Institute</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suda Sibunruang, MD</last_name>
      <phone>+66 2 2520161</phone>
      <phone_ext>125</phone_ext>
      <email>sudapunrin@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Terapong Tantawichien, MD</last_name>
      <phone>+66 2 2520161</phone>
      <phone_ext>132</phone_ext>
      <email>terapong_tantawichien@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 14, 2017</study_first_submitted>
  <study_first_submitted_qc>July 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>April 28, 2022</last_update_submitted>
  <last_update_submitted_qc>April 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen Saovabha Memorial Institute</investigator_affiliation>
    <investigator_full_name>Suda Sibunruang</investigator_full_name>
    <investigator_title>Medical doctor</investigator_title>
  </responsible_party>
  <keyword>rabies vaccination</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rabies</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/NCT03228069
org study id: 1/2017
nct id: NCT03228069
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To study the humoral and cell-mediated immune responses in HIV-infected adults who had
      previously received rabies booster vaccination more than a year before
Previous study has shown the higher immunogenicity response among HIV-infected adults who
      received a single visit 4-site intradermal rabies booster vaccination than those who received
      the conventional intramuscular regimen. The investigators follow the persistence of these
      effects. Also, the regulatory T cell levels were examined after the rabies booster
      vaccination .
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The volunteers who participated in the previous clinical trials were invited to join this study. Of which, there were 2 groups, one received a single visit 4-site intradermal rabies booster vaccination. The another received a conventional intramuscular rabies booster vaccination on day 0 and 3.
primary purpose: Treatment
masking: None (Open Label)
measure: Rabies Neutralizing Antibody Titers (RNab)
time frame: GMTs of RNab and proportion of volunteers who have had RNab above protective antibody levels (0.5 IU/ml) after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.
description: Rabies Neutralizing Antibody Titers would be represented and compared by geometric mean titers (GMTs)
measure: Rabies specific T cell response
time frame: Numbers of spots, of which represent the rabies specific T cell response after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.
description: Rabies specific T cell response is measured by Enzyme - linked Immunospot Assay (ELISPOT)
measure: Rabies specific regulatory T cells
time frame: Numbers of Rabies specific regulatory T cells after receipt of rabies booster vaccination at least a year before were compared between 2 arms at one time point on the date of study recruitment.
description: Rabies specific regulatory T cells is measured by flow cytometry method
arm group label: single visit 4-site ID vaccination
arm group type: Experimental
description: Blood would be drawn from those who received a single visit 4-site ID rabies booster vaccination in the previous trial.
arm group label: Conventional IM vaccination
arm group type: Active Comparator
description: Blood would be drawn from those who received a conventional intramuscular rabies booster vaccination in the previous trial.
intervention type: Procedure
intervention name: Blood drawn after rabies booster vaccination
description: Blood would be drawn for testing of rabies neutralizing antibody titers, rabies specific T lymphocytes and regulatory T cells after receipt of rabies booster vaccination at least a year before.
arm group label: Conventional IM vaccination
arm group label: single visit 4-site ID vaccination
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Suda Sibunruang, MD
role: Principal Investigator
affiliation: Queen Saovabha Memorial Institute
last name: Suda Sibunruang, MD
phone: +66 2 2520161
phone ext: 125
email: sudapunrin@gmail.com
last name: Terapong Tantawichien, MD
phone: +66 2 2520161
phone ext: 132
email: terapong_tantawichien@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Queen Saovabha Memorial Institute
investigator full name: Suda Sibunruang
investigator title: Medical doctor
mesh term: Rabies
sharing ipd: No