<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/NCT04441047</url>
  </required_header>
  <id_info>
    <org_study_id>MBI-001-ALLOPRIME</org_study_id>
    <nct_id>NCT04441047</nct_id>
  </id_info>
  <brief_title>Universal Anti-Viral Vaccine for Healthy Elderly Adults</brief_title>
  <acronym>ALLOPRIME</acronym>
  <official_title>Safety and Efficacy of ALLOSTIM® Universal Anti-Viral Immunodulatory Vaccine for Healthy Elderly Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Immunovative Therapies, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mirror Biologics, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Immunovative Therapies, Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This protocol tests the safety and efficacy of a novel universal vaccine concept called&#xD;
      &quot;allo-priming&quot; which is designed to protect elderly adults from progression of any type of&#xD;
      viral infection, including possible protection against progression of the current outbreak of&#xD;
      COVID-19 infection, and any future variants, strains, mutations of the causative SARS-CoV-2&#xD;
      virus as well as protection from any future currently unknown newly emergent novel viruses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed Allo-Prime universal viral protection mechanism involves vaccination with a&#xD;
      bioengineered living allogeneic cellular vaccine (AlloStim) derived from healthy blood&#xD;
      donors. The vaccine is designed to create high titers of memory immune cells that are&#xD;
      specific to the foreign antigens in the living cell vaccine. Upon encounter with any type of&#xD;
      virus, these memory immune cells are activated and release cytokines including an immediate&#xD;
      release of IFN-ϒ. This non-specific activation causes immune conditions similar to the&#xD;
      conditions that occur in healthy younger patients that leads to rapid viral clearance and&#xD;
      viral-specific memory immune response to clear infection and protect against recurrence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2021</start_date>
  <completion_date type="Actual">April 1, 2023</completion_date>
  <primary_completion_date type="Actual">March 1, 2023</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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Subjects over 65yo in two cohorts: ages 65-74 and age 75+</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>frequency of vaccine events</measure>
    <time_frame>day 0 to day 28</time_frame>
    <description>vaccine events such as fever, rash, abnormal vital signs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of subjects with positive T-cell response</measure>
    <time_frame>day 0 to 1 year</time_frame>
    <description>measurement of Th1/Th2 balance, allo-specific Th1/CTL response</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of subjects able to suppress viral propagation</measure>
    <time_frame>day 0 to 1 year</time_frame>
    <description>ex-vivo challenge of blood samples with live virus including SARS-CoV-2, influenza A and B</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Virus Diseases</condition>
  <condition>Pneumonia</condition>
  <condition>COVID-19 Respiratory Infection</condition>
  <condition>RSV Pneumonia</condition>
  <condition>Influenza, Human</condition>
  <condition>ARDS, Human</condition>
  <arm_group>
    <arm_group_label>Vaccination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ID injection AlloStim Days 0, 3/4, 7, 10/11 and 14</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AlloStim</intervention_name>
    <description>Living, activated allogeneic Th1-like memory immune cells</description>
    <arm_group_label>Vaccination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females who are at least 65 years of age at time of enrollment&#xD;
&#xD;
          2. Good general health *&#xD;
&#xD;
          3. Clinical screening laboratory evaluations (white blood cell (WBC), hemoglobin (Hgb),&#xD;
             platelets (PLTs), alanine transaminase (ALT), aspartate transaminase (AST), creatinine&#xD;
             (Cr), alkaline phosphatase (ALP), total bilirubin (T. Bili), prothrombin time (PT),&#xD;
             and partial thromboplastin time (PTT)) are within acceptable normal reference ranges&#xD;
             at the clinical laboratory being used.&#xD;
&#xD;
          4. Normal EKG&#xD;
&#xD;
          5. Available for the duration of the study&#xD;
&#xD;
          6. Peripheral veins suitable for blood draw&#xD;
&#xD;
          7. Able to provide consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. History of autoimmune disease 2. Currently being treated for cancer (other than&#xD;
             non-melanoma skin cancer) 3. History of COPD 4. Any clinical condition requiring&#xD;
             systemic steroids or any current immunosuppressive therapy 5. HIV positive or any&#xD;
             other type of immunodeficiency disorder 6. History of cardiac disease: congestive&#xD;
             heart failure &gt; NYHA class 2; cardiac arrhythmias requiring anti-arrhythmic therapy&#xD;
             (beta blockers or Digoxin are permitted) 7. Uncontrolled hypertension defined as SBP&#xD;
             ≥130 and/or DBP ≥ 80 mm Hg 8. Active clinically serious infections (&gt; grade 2 CTCAE)&#xD;
             9. History of organ transplant or tissue allograft 10. Oral temperature ≥99.0 degrees&#xD;
             Fahrenheit (37.2 degrees Celsius). 11. Pulse &lt; 60 or &gt;100 beats per minute. 12. Oxygen&#xD;
             saturation &lt;96% 13. Uncontrolled concurrent serious medical or psychiatric illness 14.&#xD;
             History of blood transfusion reactions 15. Receipt of any type of influenza vaccine or&#xD;
             COVID19 vaccine last dose within two weeks of planned first study drug injection&#xD;
             (influenza vaccination after day 28 is permitted)&#xD;
&#xD;
               -  As determined by medical history and physical examination to evaluate acute or&#xD;
                  ongoing chronic medical diagnoses/conditions that have been present for at least&#xD;
                  90 days, which would affect the assessment of safety of subjects. Chronic medical&#xD;
                  diagnoses/conditions should be stable for the last 60 days (no hospitalizations,&#xD;
                  emergency room (ER), or urgent care for condition or need for supplemental&#xD;
                  oxygen). This includes no change in chronic prescription medication, dose, or&#xD;
                  frequency as a result of deterioration of the chronic medical diagnosis/condition&#xD;
                  in the 60 days before enrollment. Any prescription change that is due to change&#xD;
                  of health care provider, insurance company, etc., or done for financial reasons,&#xD;
                  and in the same class of medication, will not be considered a deviation of this&#xD;
                  inclusion criterion. Any change in prescription medication due to improvement of&#xD;
                  a disease outcome, as determined by the participating site principal investigator&#xD;
                  (PI) or appropriate sub-investigator, will not be considered a deviation of this&#xD;
                  inclusion criterion.&#xD;
&#xD;
        Subjects may be on chronic or as needed (prn) medications if, in the opinion of the&#xD;
        participating site PI or appropriate sub-investigator, they pose no additional risk to&#xD;
        subject safety or assessment of reactogenicity and immunogenicity, and do not indicate a&#xD;
        worsening of medical diagnosis/condition. Similarly, medication changes subsequent to&#xD;
        enrollment and study vaccination are acceptable provided the change was not precipitated by&#xD;
        deterioration in the chronic medical condition, and there is no anticipated additional risk&#xD;
        to the subject or interference with the evaluation of responses to study vaccination.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Fineberg, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mirror Biologics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Delray Physician Care Center</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33445</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coral Research Clinic &amp; Coral Diagnostic</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33186</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Model Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Medical Clinic, LLC</name>
      <address>
        <city>Zephyrhills</city>
        <state>Florida</state>
        <zip>33542</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mirrorbio.com</url>
    <description>sponsor website</description>
  </link>
  <reference>
    <citation>Har-Noy M, Or R. Allo-priming as a universal anti-viral vaccine: protecting elderly from current COVID-19 and any future unknown viral outbreak. J Transl Med. 2020 May 12;18(1):196. doi: 10.1186/s12967-020-02363-3.</citation>
    <PMID>32398026</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>April 17, 2023</last_update_submitted>
  <last_update_submitted_qc>April 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>universal viral vaccine</keyword>
  <keyword>COVID-19</keyword>
  <keyword>AlloStim</keyword>
  <keyword>elderly</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</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/NCT04441047
org study id: MBI-001-ALLOPRIME
nct id: NCT04441047
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This protocol tests the safety and efficacy of a novel universal vaccine concept called
      "allo-priming" which is designed to protect elderly adults from progression of any type of
      viral infection, including possible protection against progression of the current outbreak of
      COVID-19 infection, and any future variants, strains, mutations of the causative SARS-CoV-2
      virus as well as protection from any future currently unknown newly emergent novel viruses.
The proposed Allo-Prime universal viral protection mechanism involves vaccination with a
      bioengineered living allogeneic cellular vaccine (AlloStim) derived from healthy blood
      donors. The vaccine is designed to create high titers of memory immune cells that are
      specific to the foreign antigens in the living cell vaccine. Upon encounter with any type of
      virus, these memory immune cells are activated and release cytokines including an immediate
      release of IFN-ϒ. This non-specific activation causes immune conditions similar to the
      conditions that occur in healthy younger patients that leads to rapid viral clearance and
      viral-specific memory immune response to clear infection and protect against recurrence.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects over 65yo in two cohorts: ages 65-74 and age 75+
primary purpose: Prevention
masking: None (Open Label)
measure: frequency of vaccine events
time frame: day 0 to day 28
description: vaccine events such as fever, rash, abnormal vital signs
measure: Proportion of subjects with positive T-cell response
time frame: day 0 to 1 year
description: measurement of Th1/Th2 balance, allo-specific Th1/CTL response
measure: Proportion of subjects able to suppress viral propagation
time frame: day 0 to 1 year
description: ex-vivo challenge of blood samples with live virus including SARS-CoV-2, influenza A and B
arm group label: Vaccination
arm group type: Experimental
description: ID injection AlloStim Days 0, 3/4, 7, 10/11 and 14
intervention type: Drug
intervention name: AlloStim
description: Living, activated allogeneic Th1-like memory immune cells
arm group label: Vaccination
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Fineberg, MD
role: Study Director
affiliation: Mirror Biologics, Inc.
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.mirrorbio.com
description: sponsor website
citation: Har-Noy M, Or R. Allo-priming as a universal anti-viral vaccine: protecting elderly from current COVID-19 and any future unknown viral outbreak. J Transl Med. 2020 May 12;18(1):196. doi: 10.1186/s12967-020-02363-3.
PMID: 32398026
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Respiratory Tract Infections
mesh term: Virus Diseases
mesh term: Influenza, Human
mesh term: Respiratory Distress Syndrome
sharing ipd: No