<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/NCT04436471</url>
  </required_header>
  <id_info>
    <org_study_id>02-Gam-COVID-Vac-2020</org_study_id>
    <nct_id>NCT04436471</nct_id>
  </id_info>
  <brief_title>An Open Study of the Safety, Tolerability and Immunogenicity of the Drug &quot;Gam-COVID-Vac&quot; Vaccine Against COVID-19</brief_title>
  <official_title>An Open Study of the Safety, Tolerability and Immunogenicity of the Drug &quot;Gam-COVID-Vac&quot; a Solution for Intramuscular Injection With the Participation of Healthy Volunteers</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>
    <collaborator>
      <agency>Acellena Contract Drug Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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 purpose of the study is to assess safety, tolerability and immunogenicity of the drug&#xD;
      &quot;Gam-COVID-Vac &quot;, a solution for intramuscular administration, with the participation of&#xD;
      healthy volunteers&#xD;
&#xD;
      Study objectives A safety and tolerability assessment of the drug &quot;Gam-COVID-Vac &quot;, solution&#xD;
      for intramuscular administration, using single dose of each component (Stage 1).&#xD;
&#xD;
      A safety and tolerability assessment of the drug &quot;Gam-COVID-Vac &quot;, solution for intramuscular&#xD;
      administration, using prime-boost immunization according to the proposed scheme (Stage 2).&#xD;
&#xD;
      Post-vaccination immunity assessment at different time points after vaccination by:&#xD;
&#xD;
        -  Determination of antigen-specific antibody titer in blood serum by ELISA by comparison&#xD;
           with baseline values before the vaccine administration and at days 14, 21, 28, and 42&#xD;
           after vaccination (hereinafter, the countdown comes from the first time of the vaccine&#xD;
           administration);&#xD;
&#xD;
        -  Determination of virus neutralizing antibody titer before and at days 14, 28, and 42&#xD;
           after vaccination;&#xD;
&#xD;
        -  Determination of antigen-specific cellular immunity (specific T-cell immunity) before&#xD;
           the vaccine administration and at days 14 and 28 after vaccination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open two stage non-randomized Phase 1 study with the participation of healthy volunteers.&#xD;
      This clinical trial is an open study of safety, tolerability and immunogenicity of the drug&#xD;
      &quot;Gam-COVID-Vac &quot;, ly solution for intramuscular administration, with the participation of&#xD;
      healthy volunteers.&#xD;
&#xD;
      Stage one&#xD;
&#xD;
        1. the First group, 9 volunteers, will receive the drug, a solution for intramuscular&#xD;
           administration, in the mode of single immunization with component 1 in a full&#xD;
           therapeutic dose.&#xD;
&#xD;
        2. the Second group, 9 volunteers, will receive the drug, a solution for intramuscular&#xD;
           administration, in the mode of single immunization with component 2 in the full&#xD;
           therapeutic dose.&#xD;
&#xD;
      The studied drugs will be administered to a total of 18 volunteers in a hospital setting and&#xD;
      after administration, the drug's safety will be continuously monitored for 5 days. Based on&#xD;
      the results of the safety assessment, the Chief investigator decides to proceed to the second&#xD;
      stage of the study on the 5th day after the introduction of the studied drugs.&#xD;
&#xD;
      Second stage The second stage will include 20 volunteers and three understudies. Volunteers&#xD;
      of the second stage will be vaccinated no earlier than 5 days after vaccination of&#xD;
      participants of the first stage.&#xD;
&#xD;
      Volunteers participating in the second stage of the study (a total of 20 people) will receive&#xD;
      the study drug according to the booster scheme: the introduction of component 1 will be&#xD;
      carried out on day 1, and component 2-on the 21st day of the study. Follow-up will be carried&#xD;
      out during 4 visits: on 7, 14, 28, 42 days after administration of the drug, and phone calls&#xD;
      at days 90 and 180&#xD;
&#xD;
      Throughout the inpatient observation and the follow-up period of visits during the entire&#xD;
      study, safety information will be collected&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Actual">August 10, 2020</completion_date>
  <primary_completion_date type="Actual">August 3, 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</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>An open, prospective, two-stage, non-randomized, first-phase study involving healthy volunteers</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changing ofantibody levels against the SARS-CoV-2 glycoprotein S in 42 days</measure>
    <time_frame>at days 0,14, 21, 28, 42</time_frame>
    <description>Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>through the whole study, an average of 180 days</time_frame>
    <description>Determination of Number of Participants With Adverse Events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changing of of virus neutralizing antibody titer</measure>
    <time_frame>at days 0,14, 28, 42</time_frame>
    <description>Determination of virus neutralizing antibody titer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changing of antigen-specific cellular immunity level</measure>
    <time_frame>at days 0,14, 42</time_frame>
    <description>Determination of antigen-specific cellular immunity (specific T-cell immunityin particular, IFN-gamma production or lymphoproliferation)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Preventive Immunization COVID-19</condition>
  <arm_group>
    <arm_group_label>Component 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rAd26 Component, 1 vaccination&#xD;
Component 1 consists of a recombinant adenovirus vector based on the human adenovirus type 26, containing the SARS-CoV-2 S protein gene</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Component 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rAd5 Component, 1 vaccination&#xD;
Component 2 consists of a vector based on the human adenovirus type 5, containing the SARS-CoV-2 S protein gene.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prime-Boost Immunization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1 rAd26 Component Day 21 rAd5 Component</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Gam-COVID-Vac</intervention_name>
    <description>adenoviral-based vaccine against SARS-CoV-2</description>
    <arm_group_label>Component 1</arm_group_label>
    <arm_group_label>Component 2</arm_group_label>
    <arm_group_label>Prime-Boost Immunization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. males and females within the age range from 18 to 60 years;&#xD;
&#xD;
          2. written informed consent;&#xD;
&#xD;
          3. subject body mass index (BMI): 18.5 ≤ BMI ≤ 30;&#xD;
&#xD;
          4. negative PCR test results for SARS-CoV-2 (during the screening);&#xD;
&#xD;
          5. no history of COVID-2019 disease;&#xD;
&#xD;
          6. no contacts of volunteers with patients with COVID-2019 for at least 14 days;&#xD;
&#xD;
          7. negative test results for IgM and IgG antibodies to SARS-CoV-2;&#xD;
&#xD;
          8. subject agrees to use effective contraceptive methods during the entire period of&#xD;
             participation in the study;&#xD;
&#xD;
          9. absence of acute infectious diseases at the time of vaccine administration and 14 days&#xD;
             before vaccination;&#xD;
&#xD;
         10. negative pregnancy test of blood or urine (for women of childbearing age);&#xD;
&#xD;
         11. subject has negative tests for HIV, hepatitis B and С, syphilis or confirmed medical&#xD;
             history;&#xD;
&#xD;
         12. subject has a negative result of the urine test for residual narcotic drugs;&#xD;
&#xD;
         13. negative test for alcohol in exhaled air;&#xD;
&#xD;
         14. the absence of malignant diseases of any nature and localization;&#xD;
&#xD;
         15. in medical history and based on the screening results, subject has no diseases or&#xD;
             pathologies of the gastrointestinal system, liver, kidneys, cardiovascular system and&#xD;
             blood, CNS, musculoskeletal system, urogenital, immune and endocrine systems that from&#xD;
             the point of view of the researcher and/or of the organizer of the study, may affect&#xD;
             the safety of the volunteer and the evaluation of the study results (clinical,&#xD;
             instrumental and laboratory tests did not reveal diseases or clinically significant&#xD;
             deviations).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. volunteer involvement in another study over the last 90 days;&#xD;
&#xD;
          2. any vaccination over the last 30 days;&#xD;
&#xD;
          3. history of COVID-2019 disease;&#xD;
&#xD;
          4. positive PCR test results for SARS-CoV-2 (during the screening);&#xD;
&#xD;
          5. positive test results for IgM and IgG antibodies to SARS-CoV-2;&#xD;
&#xD;
          6. health staff in contact with people with COVID-2019;&#xD;
&#xD;
          7. respiratory symptoms in the last 14 days;&#xD;
&#xD;
          8. the administration of immunoglobulins or other blood products in the last 3 months;&#xD;
&#xD;
          9. regular current or past use of narcotic drugs;&#xD;
&#xD;
         10. subject has received immunosuppressive and/or immunomodulating agents within 6 months&#xD;
             before the start of the study;&#xD;
&#xD;
         11. pregnancy or breast feeding;&#xD;
&#xD;
         12. exacerbation of allergic diseases at the time of vaccination;&#xD;
&#xD;
         13. subject has systolic blood pressure less than 100 mm Hg or greater than 139 mm Hg;&#xD;
             diastolic blood pressure less than 60 mm Hg or greater than 90 mm Hg; heart rate lower&#xD;
             than 60 beats per minute or above 100 beats per minute;&#xD;
&#xD;
         14. a burdened allergic history (anaphylactic shock, Quincke's edema, polymorphic&#xD;
             exudative eczema, atopy, a history of serum sickness, hypersensitivity or allergic&#xD;
             reactions to the introduction of any vaccines in history, known allergic reactions to&#xD;
             vaccine components, etc.);&#xD;
&#xD;
         15. a history of autoimmune diseases in the volunteer's medical history and in relatives'&#xD;
             medical history of the 1-2 degree of kinship;&#xD;
&#xD;
         16. subject smokes more than 10 cigarettes per day;&#xD;
&#xD;
         17. alcohol intake exceeding the low-risk level: no more than 20 grams of pure alcohol per&#xD;
             day, no more than 5 days a week, alcohol intake within 48 hours before the&#xD;
             administration of the drug;&#xD;
&#xD;
         18. planned hospitalization and/or surgery during the period of participation in the&#xD;
             study, as well as 4 weeks before the expected date of the administration of the drug;&#xD;
&#xD;
         19. the presence of an associated disease that may affect the assessment of the results of&#xD;
             the study;&#xD;
&#xD;
         20. any conditions that, according to the researcher's doctor, may be a contraindication&#xD;
             to the participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Main military clinical hospital named after academician N. N. Burdenko</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>vector vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04436471
org study id: 02-Gam-COVID-Vac-2020
nct id: NCT04436471
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to assess safety, tolerability and immunogenicity of the drug
      "Gam-COVID-Vac ", a solution for intramuscular administration, with the participation of
      healthy volunteers

      Study objectives A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution
      for intramuscular administration, using single dose of each component (Stage 1).

      A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular
      administration, using prime-boost immunization according to the proposed scheme (Stage 2).

      Post-vaccination immunity assessment at different time points after vaccination by:

        -  Determination of antigen-specific antibody titer in blood serum by ELISA by comparison
           with baseline values before the vaccine administration and at days 14, 21, 28, and 42
           after vaccination (hereinafter, the countdown comes from the first time of the vaccine
           administration);

        -  Determination of virus neutralizing antibody titer before and at days 14, 28, and 42
           after vaccination;

        -  Determination of antigen-specific cellular immunity (specific T-cell immunity) before
           the vaccine administration and at days 14 and 28 after vaccination.
An open two stage non-randomized Phase 1 study with the participation of healthy volunteers.
      This clinical trial is an open study of safety, tolerability and immunogenicity of the drug
      "Gam-COVID-Vac ", ly solution for intramuscular administration, with the participation of
      healthy volunteers.

      Stage one

        1. the First group, 9 volunteers, will receive the drug, a solution for intramuscular
           administration, in the mode of single immunization with component 1 in a full
           therapeutic dose.

        2. the Second group, 9 volunteers, will receive the drug, a solution for intramuscular
           administration, in the mode of single immunization with component 2 in the full
           therapeutic dose.

      The studied drugs will be administered to a total of 18 volunteers in a hospital setting and
      after administration, the drug's safety will be continuously monitored for 5 days. Based on
      the results of the safety assessment, the Chief investigator decides to proceed to the second
      stage of the study on the 5th day after the introduction of the studied drugs.

      Second stage The second stage will include 20 volunteers and three understudies. Volunteers
      of the second stage will be vaccinated no earlier than 5 days after vaccination of
      participants of the first stage.

      Volunteers participating in the second stage of the study (a total of 20 people) will receive
      the study drug according to the booster scheme: the introduction of component 1 will be
      carried out on day 1, and component 2-on the 21st day of the study. Follow-up will be carried
      out during 4 visits: on 7, 14, 28, 42 days after administration of the drug, and phone calls
      at days 90 and 180

      Throughout the inpatient observation and the follow-up period of visits during the entire
      study, safety information will be collected
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: An open, prospective, two-stage, non-randomized, first-phase study involving healthy volunteers
primary purpose: Prevention
masking: None (Open Label)
measure: Changing ofantibody levels against the SARS-CoV-2 glycoprotein S in 42 days
time frame: at days 0,14, 21, 28, 42
description: Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
measure: Number of Participants With Adverse Events
time frame: through the whole study, an average of 180 days
description: Determination of Number of Participants With Adverse Events
measure: Changing of of virus neutralizing antibody titer
time frame: at days 0,14, 28, 42
description: Determination of virus neutralizing antibody titer
measure: Changing of antigen-specific cellular immunity level
time frame: at days 0,14, 42
description: Determination of antigen-specific cellular immunity (specific T-cell immunityin particular, IFN-gamma production or lymphoproliferation)
arm group label: Component 1
arm group type: Experimental
description: rAd26 Component, 1 vaccination
Component 1 consists of a recombinant adenovirus vector based on the human adenovirus type 26, containing the SARS-CoV-2 S protein gene
arm group label: Component 2
arm group type: Experimental
description: rAd5 Component, 1 vaccination
Component 2 consists of a vector based on the human adenovirus type 5, containing the SARS-CoV-2 S protein gene.
arm group label: Prime-Boost Immunization
arm group type: Experimental
description: Day 1 rAd26 Component Day 21 rAd5 Component
intervention type: Biological
intervention name: Gam-COVID-Vac
description: adenoviral-based vaccine against SARS-CoV-2
arm group label: Component 1
arm group label: Component 2
arm group label: Prime-Boost Immunization
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No