<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/NCT03789539</url>
  </required_header>
  <id_info>
    <org_study_id>UIV-I-01/2017</org_study_id>
    <nct_id>NCT03789539</nct_id>
  </id_info>
  <brief_title>Reactogenicity, Safety and Immunogenicity of an Universal Influenza Vaccine Uniflu</brief_title>
  <official_title>Reactogenicity, Safety and Immunogenicity of an Recombinant Universal Influenza Vaccine Uniflu in Healthy Volunteers From 18 to 60 Years Old</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Pharma Limited Liability Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Pharma Limited Liability Company</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty&#xD;
      four (54) volunteers 18-60 years of age with a dose escalation.&#xD;
&#xD;
      All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval&#xD;
      between treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty&#xD;
      four (54) volunteers 18-60 years of age.&#xD;
&#xD;
      All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval&#xD;
      between treatments.&#xD;
&#xD;
      Subjects will undergo screening procedures within 6 days prior to first vaccination which&#xD;
      will include medical history, vital signs, physical examination and safety blood and urine&#xD;
      lab tests.&#xD;
&#xD;
      On the first treatment visit, eligible subjects will undergo pre-dose physical&#xD;
      examination,vital signs, ECG, a blood sample will be drawn for circulating IgE. They receive&#xD;
      an IM injection of either vaccine or placebo, according to the above treatment assignment,&#xD;
      into the deltoid muscle. The subjects will remain under medical supervision for 72 hrs, after&#xD;
      that time they will be released from the Clinical research center.&#xD;
&#xD;
      The second treatment will take place 21 days after the first vaccination. Procedures will be&#xD;
      the same as on the first treatment visit.&#xD;
&#xD;
      Follow-up visits take place at 4th, 5th, 6th, 14th, 35th days. A Study Termination visit will&#xD;
      take place at 42nd day of research. Adverse events (AEs) and changes in concomitant&#xD;
      medications will be recorded, vital signs will be measured and the subjects will undergo&#xD;
      physical examination and ECG. Blood and urine samples will be collected for safety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 2, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 2, 2018</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Subjects will undergo screening procedures within 2-6 days prior to first vaccination which will include medical history, vital signs, physical examination and safety blood and urine lab tests.&#xD;
On the first treatment visit, eligible subjects will undergo pre-dose physical examination, ECG, vital signs, and a blood sample for circulating IgE. They will then receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle preferably of non dominant arm. The subjects will remain under medical supervision for 72 hrs at which time they will be released from the Clinical research center.&#xD;
The second treatment will take place 21 days after the first vaccination. Procedures will be the same as that of Visit 1 Additional follow-up visits will take place at 4-7th,14th,24-27th and 42nd days. Blood and urine samples will be collected for safety.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse events in treatment vs control group</measure>
    <time_frame>42 days (from first visit to termination visit for each subject)</time_frame>
    <description>Estimation the quantity of adverse events in treatment group vs control group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of Immunogenicity</measure>
    <time_frame>Time Frame: at days 1, 21, 42.</time_frame>
    <description>Determination of antibody levels of IgG to M2e protein measured by IFA vs. baseline values</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Safety Issues</condition>
  <arm_group>
    <arm_group_label>LD Universal Influenza Vaccine Uniflu</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>low dose of Uniflu vaccine 0.5 ml (20 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HD Universal Influenza Vaccine Uniflu</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>high dose of Uniflu vaccine 0.5 ml (40 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>saline 0.5 ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>LD Universal Influenza Vaccine Uniflu</intervention_name>
    <description>low dose Universal Influenza Vaccine Uniflu</description>
    <arm_group_label>LD Universal Influenza Vaccine Uniflu</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>HD Universal Influenza Vaccine Uniflu</intervention_name>
    <description>High dose Universal Influenza Vaccine Uniflu</description>
    <arm_group_label>HD Universal Influenza Vaccine Uniflu</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo saline</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women aged 18 to 60 years old.&#xD;
&#xD;
          2. Healthy that verificated by vital signs, physical examination, blood and urine lab&#xD;
             tests&#xD;
&#xD;
          3. Body mass index (BMI) from 18.5 to 30.5 weight &gt;50 kg&#xD;
&#xD;
          4. Written informed consent.&#xD;
&#xD;
          5. Consent to the use of effective contraceptive methods throughout the study period.&#xD;
&#xD;
          6. Negative pregnancy test (for fertile women), consent to the use of effective&#xD;
             contraceptive methods throughout the study period.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Participation of a volunteer in any other study in the last 90 days; any vaccination&#xD;
             in the last 30 days;&#xD;
&#xD;
          2. Vaccination within 6 months before the start of the study (including during&#xD;
             participation in other clinical trials).&#xD;
&#xD;
          3. Symptoms of respiratory illness in the last 3 days.&#xD;
&#xD;
          4. Symptoms of any acute in the screening period.&#xD;
&#xD;
          5. Administration of immunoglobulins or other blood products for the last 3 months.&#xD;
&#xD;
          6. Taking immunosuppressive drugs and / or immunomodulators within 6 months before the&#xD;
             start of the study.&#xD;
&#xD;
          7. Hypersensitivity or allergic reactions to the administration of any vaccine in medical&#xD;
             history.&#xD;
&#xD;
          8. The presence of anaphylactic reactions, angioedema or other SAE to the administration&#xD;
             of any vaccine in medical history.&#xD;
&#xD;
          9. Allergic reactions to vaccine components.&#xD;
&#xD;
         10. Seasonal allergy (at autumn period).&#xD;
&#xD;
         11. Acute or chronical desease or pathology from the gastrointestinal tract, liver,&#xD;
             kidneys, cardiovascular system, central nervous system, musculoskeletal system,&#xD;
             genitourinary and endocrine systems, which may influence the evaluation of the results&#xD;
             of the study, in the anamnesis and also according to the screening examination data&#xD;
&#xD;
         12. Leukemia or any other blood disease or malignancy of other organs.&#xD;
&#xD;
         13. Thrombocytopenic purpura or bleeding disorders in medical history.&#xD;
&#xD;
         14. Seizures in medical history.&#xD;
&#xD;
         15. The presence or suspected presence of various immunosuppressive or immunodeficient&#xD;
             state, including HIV infection.&#xD;
&#xD;
         16. Hepatitis B and C.&#xD;
&#xD;
         17. Tuberculosis.&#xD;
&#xD;
         18. Regular past or current use of narcotic drugs.&#xD;
&#xD;
         19. Pregnancy or breastfeeding.&#xD;
&#xD;
         20. Any conditions which may influence the evaluation of the results of the study, in the&#xD;
             anamnesis and also according to the screening examination data.&#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>
  <overall_official>
    <last_name>Julia M Savateeva, PhD</last_name>
    <role>Study Director</role>
    <affiliation>VA Pharma Limited Liability Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Institute of Influenza</name>
      <address>
        <city>Sankt-Petersburg</city>
        <state>Saint-Petersburg</state>
        <zip>197376</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>December 25, 2018</last_update_submitted>
  <last_update_submitted_qc>December 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Safety</keyword>
  <keyword>Reactogenicity</keyword>
  <keyword>Universal Influenza Vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03789539
org study id: UIV-I-01/2017
nct id: NCT03789539
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty
      four (54) volunteers 18-60 years of age with a dose escalation.

      All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval
      between treatments.
This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty
      four (54) volunteers 18-60 years of age.

      All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval
      between treatments.

      Subjects will undergo screening procedures within 6 days prior to first vaccination which
      will include medical history, vital signs, physical examination and safety blood and urine
      lab tests.

      On the first treatment visit, eligible subjects will undergo pre-dose physical
      examination,vital signs, ECG, a blood sample will be drawn for circulating IgE. They receive
      an IM injection of either vaccine or placebo, according to the above treatment assignment,
      into the deltoid muscle. The subjects will remain under medical supervision for 72 hrs, after
      that time they will be released from the Clinical research center.

      The second treatment will take place 21 days after the first vaccination. Procedures will be
      the same as on the first treatment visit.

      Follow-up visits take place at 4th, 5th, 6th, 14th, 35th days. A Study Termination visit will
      take place at 42nd day of research. Adverse events (AEs) and changes in concomitant
      medications will be recorded, vital signs will be measured and the subjects will undergo
      physical examination and ECG. Blood and urine samples will be collected for safety.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will undergo screening procedures within 2-6 days prior to first vaccination which will include medical history, vital signs, physical examination and safety blood and urine lab tests.
On the first treatment visit, eligible subjects will undergo pre-dose physical examination, ECG, vital signs, and a blood sample for circulating IgE. They will then receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle preferably of non dominant arm. The subjects will remain under medical supervision for 72 hrs at which time they will be released from the Clinical research center.
The second treatment will take place 21 days after the first vaccination. Procedures will be the same as that of Visit 1 Additional follow-up visits will take place at 4-7th,14th,24-27th and 42nd days. Blood and urine samples will be collected for safety.
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of participants with adverse events in treatment vs control group
time frame: 42 days (from first visit to termination visit for each subject)
description: Estimation the quantity of adverse events in treatment group vs control group
measure: Assessment of Immunogenicity
time frame: Time Frame: at days 1, 21, 42.
description: Determination of antibody levels of IgG to M2e protein measured by IFA vs. baseline values
arm group label: LD Universal Influenza Vaccine Uniflu
arm group type: Active Comparator
description: low dose of Uniflu vaccine 0.5 ml (20 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals
arm group label: HD Universal Influenza Vaccine Uniflu
arm group type: Active Comparator
description: high dose of Uniflu vaccine 0.5 ml (40 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals
arm group label: Placebo
arm group type: Placebo Comparator
description: saline 0.5 ml
intervention type: Biological
intervention name: LD Universal Influenza Vaccine Uniflu
description: low dose Universal Influenza Vaccine Uniflu
arm group label: LD Universal Influenza Vaccine Uniflu
intervention type: Biological
intervention name: HD Universal Influenza Vaccine Uniflu
description: High dose Universal Influenza Vaccine Uniflu
arm group label: HD Universal Influenza Vaccine Uniflu
intervention type: Biological
intervention name: Placebo
description: Placebo saline
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Julia M Savateeva, PhD
role: Study Director
affiliation: VA Pharma Limited Liability Company
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Vaccines
sharing ipd: Undecided