<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/NCT03255278</url>
  </required_header>
  <id_info>
    <org_study_id>GamTBvac Ph1</org_study_id>
    <nct_id>NCT03255278</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine &quot;GamTBvac&quot; Against the Tuberculosis.</brief_title>
  <acronym>GamTBvac</acronym>
  <official_title>Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine &quot;GamTBvac&quot; Against the Tuberculosis. Comparative Placebo-controlled Study With a Two-fold Increase of the Vaccine Dose in Healthy Volunteers Aged 18-49 Years.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation</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 study is aimed to evaluate the safety and immunogenicity of the medicinal product&#xD;
      &quot;GamTBvac&quot; - a recombinant subunit vaccine against the tuberculosis. The study is designed as&#xD;
      a comparative placebo-controlled study with a two-fold increase of an applied dose among&#xD;
      healthy volunteers aged 18-49 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical trial study of the &quot;GamTBvac&quot; vaccine against the tuberculosis is a comparative&#xD;
      placebo-controlled study with a two-fold increase of an applied dose among healthy volunteers&#xD;
      aged 18-49 years. The product &quot;GamTBvac&quot; is a lyophilized substance consisted of the purified&#xD;
      recombinant subunit antigens of Mycobacterium tuberculosis, that is applied for the preparing&#xD;
      of the solution for a subcutaneous administration. Currently the study is at the first phase.&#xD;
&#xD;
      The aims of the study are: a) to confirm the safety of the product in the healthy volunteers;&#xD;
      b) to select the optimal administration dose; c) to evaluate of the immunogenicity of the&#xD;
      vaccine; d) to investigate the immune cell memory as a response to the vaccination.&#xD;
&#xD;
      The total number of the volunteers in the study is 60:&#xD;
&#xD;
        1. at the first stage to estimate the safety and portable of the vaccine, two groups of&#xD;
           volunteers each includes 12 persons got the single decreased dose (0.25 of the planned&#xD;
           dose for regular administration) of the vaccine (the first group, 12 persons), and the&#xD;
           0.5 ml of the placebo (the second group, 12 persons);&#xD;
&#xD;
        2. at the second stage to select the optimal dose and the scheme of the vaccine&#xD;
           administration, additionally three groups, each consist of 12 persons of volunteers will&#xD;
           be recruited. The first group will get double vaccination of a decreased dose (0.25 of&#xD;
           the regular dose), the second group will get the double vaccination of a mean dose (0.5&#xD;
           of the regular dose), and the third one will get the double vaccination of the maximum&#xD;
           (1.0 regular) dose.&#xD;
&#xD;
      The inclusion criteria for the volunteers of the study are: healthy males either females aged&#xD;
      18-49 years who have previously got the BCG vaccine. The exclusion criterion is the presence&#xD;
      of the latent tuberculosis in the patient that is confirmed during the preliminary laboratory&#xD;
      screening.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">December 13, 2017</completion_date>
  <primary_completion_date type="Actual">December 13, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The clinical trial study of the &quot;GamTBvac&quot; vaccine against the tuberculosis is a comparative placebo-controlled study with a two-fold increase of an applied dose among healthy volonteers aged 18-49 years.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number and severity of adverse effects</measure>
    <time_frame>140 Days</time_frame>
    <description>Safety control: an active periodical examination of the health status of volunteers, including vital indicators, instrumental tests (ECG), laboratory blood and urine analysis (general and biochemistry). The presence, nature and severity of local and systemic reactions in different groups of volunteers, depending on the dose of vaccination, will be taken into account.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>immunogenicity control</measure>
    <time_frame>140 Days</time_frame>
    <description>Qualitative ELISA test for specific IgG antibodies, study of the stimulated T-cell</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Tuberculosis</condition>
  <arm_group>
    <arm_group_label>Safety and portable study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 persons who have got a single decreased dose (0.25 of the planned dose for regular administration) of the GamTBvac recombinant subunit vaccine.&#xD;
The intervention for the Arm: single GamTBvac vaccination (0.25 dose).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo safety study group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>12 persons who have got a single dose of placebo (0.5 ml). The intervention for the Arm: Placebo administration (0.5 ml)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immunogenicity study group #1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 persons who will get a double sequential administration of the decreased dose (0.25 of the planned dose for regular applying) of the GamTBvac recombinant subunit vaccine.&#xD;
The intervention for the Arm: double GamTBvac vaccination (0.25 dose).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immunogenicity study group #2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 persons who will get a double sequential administration of the mean dose (0.5 of the planned dose for regular applying) of the GamTBvac recombinant subunit vaccine.&#xD;
The intervention for the Arm: double GamTBvac vaccination (0.5 dose).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immunogenicity study group #3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 persons who will get a double sequential administration of the maximum (regular) dose of the GamTBvac recombinant subunit vaccine.&#xD;
The intervention for the Arm: double GamTBvac vaccination (1.0 dose).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Single GamTBvac vaccination (0.25 dose)</intervention_name>
    <description>Single administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the safety.</description>
    <arm_group_label>Safety and portable study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo administration</intervention_name>
    <description>Single administration of the placebo (0.5 ml) to a placebo safety study group (Arm 2).</description>
    <arm_group_label>Placebo safety study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Double GamTBvac vaccination (0.25 dose)</intervention_name>
    <description>Double sequential administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the immunogenicity.</description>
    <arm_group_label>Immunogenicity study group #1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Double GamTBvac vaccination (0.5 dose)</intervention_name>
    <description>Double sequential administration of the mean dose of vaccine (0.5 of regular dose) to evaluate the immunogenicity.</description>
    <arm_group_label>Immunogenicity study group #2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Double GamTBvac vaccination (1.0 dose)</intervention_name>
    <description>Double sequential administration of the regular dose of vaccine to evaluate the immunogenicity.</description>
    <arm_group_label>Immunogenicity study group #3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  lack of the latent tuberculosis, laboratory confirmed&#xD;
&#xD;
          -  BCG vaccination in the past&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of the latent tuberculosis, laboratory confirmed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sechenov First Moscow State Medical University</name>
      <address>
        <city>Moscow</city>
        <zip>119435</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0176784</url>
    <description>Tkachuk AP, Gushchin VA, Potapov VD, Demidenko AV, Lunin VG, Gintsburg AL. Multi-subunit BCG booster vaccine GamTBvac: Assessment of immunogenicity and protective efficacy in murine and guinea pig TB models. PLoS One. 2017 Apr 28</description>
  </link>
  <reference>
    <citation>Tkachuk AP, Gushchin VA, Potapov VD, Demidenko AV, Lunin VG, Gintsburg AL. Multi-subunit BCG booster vaccine GamTBvac: Assessment of immunogenicity and protective efficacy in murine and guinea pig TB models. PLoS One. 2017 Apr 28;12(4):e0176784. doi: 10.1371/journal.pone.0176784. eCollection 2017.</citation>
    <PMID>28453555</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>December 25, 2017</last_update_submitted>
  <last_update_submitted_qc>December 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tuberculosis</keyword>
  <keyword>Recombinant vaccine</keyword>
  <keyword>Mycobacterium tuberculosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</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/NCT03255278
org study id: GamTBvac Ph1
nct id: NCT03255278
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is aimed to evaluate the safety and immunogenicity of the medicinal product
      "GamTBvac" - a recombinant subunit vaccine against the tuberculosis. The study is designed as
      a comparative placebo-controlled study with a two-fold increase of an applied dose among
      healthy volunteers aged 18-49 years.
The clinical trial study of the "GamTBvac" vaccine against the tuberculosis is a comparative
      placebo-controlled study with a two-fold increase of an applied dose among healthy volunteers
      aged 18-49 years. The product "GamTBvac" is a lyophilized substance consisted of the purified
      recombinant subunit antigens of Mycobacterium tuberculosis, that is applied for the preparing
      of the solution for a subcutaneous administration. Currently the study is at the first phase.

      The aims of the study are: a) to confirm the safety of the product in the healthy volunteers;
      b) to select the optimal administration dose; c) to evaluate of the immunogenicity of the
      vaccine; d) to investigate the immune cell memory as a response to the vaccination.

      The total number of the volunteers in the study is 60:

        1. at the first stage to estimate the safety and portable of the vaccine, two groups of
           volunteers each includes 12 persons got the single decreased dose (0.25 of the planned
           dose for regular administration) of the vaccine (the first group, 12 persons), and the
           0.5 ml of the placebo (the second group, 12 persons);

        2. at the second stage to select the optimal dose and the scheme of the vaccine
           administration, additionally three groups, each consist of 12 persons of volunteers will
           be recruited. The first group will get double vaccination of a decreased dose (0.25 of
           the regular dose), the second group will get the double vaccination of a mean dose (0.5
           of the regular dose), and the third one will get the double vaccination of the maximum
           (1.0 regular) dose.

      The inclusion criteria for the volunteers of the study are: healthy males either females aged
      18-49 years who have previously got the BCG vaccine. The exclusion criterion is the presence
      of the latent tuberculosis in the patient that is confirmed during the preliminary laboratory
      screening.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: The clinical trial study of the "GamTBvac" vaccine against the tuberculosis is a comparative placebo-controlled study with a two-fold increase of an applied dose among healthy volonteers aged 18-49 years.
primary purpose: Prevention
masking: Single (Participant)
measure: The number and severity of adverse effects
time frame: 140 Days
description: Safety control: an active periodical examination of the health status of volunteers, including vital indicators, instrumental tests (ECG), laboratory blood and urine analysis (general and biochemistry). The presence, nature and severity of local and systemic reactions in different groups of volunteers, depending on the dose of vaccination, will be taken into account.
measure: immunogenicity control
time frame: 140 Days
description: Qualitative ELISA test for specific IgG antibodies, study of the stimulated T-cell
arm group label: Safety and portable study group
arm group type: Experimental
description: 12 persons who have got a single decreased dose (0.25 of the planned dose for regular administration) of the GamTBvac recombinant subunit vaccine.
The intervention for the Arm: single GamTBvac vaccination (0.25 dose).
arm group label: Placebo safety study group
arm group type: Placebo Comparator
description: 12 persons who have got a single dose of placebo (0.5 ml). The intervention for the Arm: Placebo administration (0.5 ml)
arm group label: Immunogenicity study group #1
arm group type: Experimental
description: 12 persons who will get a double sequential administration of the decreased dose (0.25 of the planned dose for regular applying) of the GamTBvac recombinant subunit vaccine.
The intervention for the Arm: double GamTBvac vaccination (0.25 dose).
arm group label: Immunogenicity study group #2
arm group type: Experimental
description: 12 persons who will get a double sequential administration of the mean dose (0.5 of the planned dose for regular applying) of the GamTBvac recombinant subunit vaccine.
The intervention for the Arm: double GamTBvac vaccination (0.5 dose).
arm group label: Immunogenicity study group #3
arm group type: Experimental
description: 12 persons who will get a double sequential administration of the maximum (regular) dose of the GamTBvac recombinant subunit vaccine.
The intervention for the Arm: double GamTBvac vaccination (1.0 dose).
intervention type: Biological
intervention name: Single GamTBvac vaccination (0.25 dose)
description: Single administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the safety.
arm group label: Safety and portable study group
intervention type: Biological
intervention name: Placebo administration
description: Single administration of the placebo (0.5 ml) to a placebo safety study group (Arm 2).
arm group label: Placebo safety study group
intervention type: Biological
intervention name: Double GamTBvac vaccination (0.25 dose)
description: Double sequential administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the immunogenicity.
arm group label: Immunogenicity study group #1
intervention type: Biological
intervention name: Double GamTBvac vaccination (0.5 dose)
description: Double sequential administration of the mean dose of vaccine (0.5 of regular dose) to evaluate the immunogenicity.
arm group label: Immunogenicity study group #2
intervention type: Biological
intervention name: Double GamTBvac vaccination (1.0 dose)
description: Double sequential administration of the regular dose of vaccine to evaluate the immunogenicity.
arm group label: Immunogenicity study group #3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Russian Federation
url: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0176784
description: Tkachuk AP, Gushchin VA, Potapov VD, Demidenko AV, Lunin VG, Gintsburg AL. Multi-subunit BCG booster vaccine GamTBvac: Assessment of immunogenicity and protective efficacy in murine and guinea pig TB models. PLoS One. 2017 Apr 28
citation: Tkachuk AP, Gushchin VA, Potapov VD, Demidenko AV, Lunin VG, Gintsburg AL. Multi-subunit BCG booster vaccine GamTBvac: Assessment of immunogenicity and protective efficacy in murine and guinea pig TB models. PLoS One. 2017 Apr 28;12(4):e0176784. doi: 10.1371/journal.pone.0176784. eCollection 2017.
PMID: 28453555
responsible party type: Sponsor
mesh term: Tuberculosis
sharing ipd: No