xml: <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/NCT05991427</url>
    </required_header>
    <id_info>
      <org_study_id>CTP-CVE-001</org_study_id>
      <nct_id>NCT05991427</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Safety and Immunogenicity of ChAdOx1-VZV in Healthy Adults Aged 50-65 Years</brief_title>
    <official_title>A Phase I, Randomized, Observer Blind Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Zoster Vaccine (Adenovirus Vector) in Healthy Adults Aged 50-65 Years</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CanSino Biologics Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CanSino Biologics Inc.</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>
        This is a randomized, observer blind and controlled study. Participants in low-dose and&#xD;
        high-dose IM group will be randomized in a ratio of 2:1 to receive either the investigational&#xD;
        product or the control. Participants in the IH group will receive either inhaled&#xD;
        investigational product or saline in a ratio of 3:1. Enrollment will be in an ascending order&#xD;
        of dosage groups. All participants will receive 2 doses in 4 months interval. Blood samples&#xD;
        will be collected for immunogenicity evaluation over the time course of the study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">October 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of local and systemic reactogenicity within 7 days after each vaccination</measure>
      <time_frame>Within 7 days after each vaccination</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of Serious Adverse Event (SAE) and Adverse Event of Special Interest (AESI) from the 1st dose to the end of study.</measure>
      <time_frame>From the 1st dose to the end of study</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>The unsolicited adverse events for 28 days after each vaccination</measure>
      <time_frame>28 days after each vaccination</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The blood biochemistry parameters, include Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), on day 7 post each vaccination.</measure>
      <time_frame>Day 7 post each vaccination</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Geometric mean titer (GMT) of gE-specific antibody using Enzyme-linked Immunosorbent Assay (ELISA) over the time course.</measure>
      <time_frame>Through study completion, an average of 8 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The GMT of gE-specific antibody 28 days after the 1st and 2nd dose vaccination across each vaccination group.</measure>
      <time_frame>28 days after the 1st and 2nd dose vaccination</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The gE-specific IFN-γ by EliSpot over the time course of the study</measure>
      <time_frame>Through study completion, an average of 8 months</time_frame>
    </secondary_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Anticipated">65</enrollment>
    <condition>Herpes Zoster</condition>
    <arm_group>
      <arm_group_label>Experimental vaccine group, low dose, Intramuscular injection(IM)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2 doses of ChAdOX1-VZV vaccine (1 × 10^10 vp) on Day 0 and Month 4</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control vaccine group, low dose, IM</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>2 doses of Shingrix vaccine (0.5ml) on Day 0 and Month 4</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental vaccine group, high dose, IM</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2 doses of ChAdOX1-VZV vaccine (5 × 10^10 vp) on Day 0 and Month 4</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control vaccine group, high dose, IM</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>2 doses of Shingrix vaccine (0.5ml) on Day 0 and Month 4</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental vaccine group, Aerosol, Inhalation(IH)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2 doses of ChAdOX1-VZV vaccine (2 × 10^10 vp) on Day 0 and Month 4</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Saline group, Aerosol, IH</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>2 doses of saline (0.2ml) on Day 0 and Month 4</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Recombinant Zoster Vaccine (Adenovirus Vector) (ChAdOx1-VZV)</intervention_name>
      <description>2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4</description>
      <arm_group_label>Experimental vaccine group, low dose, Intramuscular injection(IM)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Zoster Vaccine Recombinant, Adjuvanted (Shingrix)</intervention_name>
      <description>2 doses of Shingrix vaccine on Day 0 and Month 4</description>
      <arm_group_label>Control vaccine group, low dose, IM</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>ChAdOx1-VZV</intervention_name>
      <description>2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4</description>
      <arm_group_label>Experimental vaccine group, high dose, IM</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Shingrix</intervention_name>
      <description>2 doses of Shingrix vaccine on Day 0 and Month 4</description>
      <arm_group_label>Control vaccine group, high dose, IM</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>IH ChAdOx1-VZV</intervention_name>
      <description>2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4</description>
      <arm_group_label>Experimental vaccine group, Aerosol, Inhalation(IH)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>IH saline</intervention_name>
      <description>2 doses of saline on Day 0 and Month 4</description>
      <arm_group_label>Saline group, Aerosol, IH</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants who can understand and comply with the study procedures, understand the&#xD;
               risks involved in the study, and provide written informed consent&#xD;
  &#xD;
            -  Male and female volunteers aged 50 to 65 years at time of informed consent.&#xD;
  &#xD;
            -  Healthy or in stable health participants with pre-existing, stable, well-controlled&#xD;
               disease, defined as mild disease or medical condition not requiring medical therapy or&#xD;
               not requiring a change in medical therapy due to worsening of disease during the 6&#xD;
               months before enrollment may be enrolled at the discretion of the investigator.&#xD;
  &#xD;
            -  Female participants of childbearing potential must have a negative urine pregnancy&#xD;
               test at screening and before each dose of investigational vaccine and have been using&#xD;
               an adequate form of contraception 30 days prior to first dose of investigational&#xD;
               vaccine and agree to use adequate contraception for the entire duration of their&#xD;
               participation in the study.&#xD;
  &#xD;
            -  Male participants must agree to use adequate contraception from the first dose of&#xD;
               investigational vaccine until at least 30 days after the last dose of investigational&#xD;
               vaccine.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or lactating at screening or planning to become pregnant (self or partner) at&#xD;
               any time during the study, including the follow-up period&#xD;
  &#xD;
            -  History of severe allergic reaction (e.g., anaphylaxis) to any component of the&#xD;
               vaccine.&#xD;
  &#xD;
            -  History of herpes zoster (HZ) (Shingles) in the past 5 years.&#xD;
  &#xD;
            -  Previous vaccination against HZ.&#xD;
  &#xD;
            -  History of or present substance abuse as judged by the investigator.&#xD;
  &#xD;
            -  Immunosuppression resulting from hematopoietic stem cell transplantation, acquired&#xD;
               immunodeficiency syndrome (AIDS) or symptomatic (human immunodeficiency virus) HIV&#xD;
               infection.&#xD;
  &#xD;
            -  Chronic administration of immunosuppressants (at least 10 mg per day of prednisone&#xD;
               equivalent for glucocorticoids) or other immune-modifying drugs within 6 months prior&#xD;
               to the first dose of investigational vaccine.&#xD;
  &#xD;
            -  Has received any blood products or immunoglobulin within 90 days prior to study&#xD;
               injection, or is likely to require infusion of blood products during the study period.&#xD;
  &#xD;
            -  Is undergoing chemotherapy or expected to receive chemotherapy during the study&#xD;
               period; has a diagnosis of or receiving treatment for cancer within the last 5 years.&#xD;
  &#xD;
            -  History of clinically significant thrombocytopenia or other clotting disorders.&#xD;
  &#xD;
            -  Serious cardiovascular disease (pulmonary heart disease, pulmonary edema, hypertension&#xD;
               that cannot be controlled by medication (systolic blood pressure &gt; 160 mmHg and/or&#xD;
               diastolic blood pressure &gt; 100 mmHg)), serious liver and kidney disease, and diabetes&#xD;
               mellitus with complications.&#xD;
  &#xD;
            -  History of allergic skin diseases.&#xD;
  &#xD;
            -  Use of any investigational or non-registered product (drug or vaccine) within 30 days&#xD;
               before the first dose of investigational vaccine/product, or planned use during the&#xD;
               study period.&#xD;
  &#xD;
            -  Receipt of any other immunizations within one month before the first dose of&#xD;
               investigational vaccine (2 weeks in the case of inactivated influenza vaccines or&#xD;
               other non-replicating immunization products [e.g., tetanus and reduced dose diphtheria&#xD;
               toxoid (dT) vaccine, pneumococcal vaccine, hepatitis A vaccine, hepatitis B vaccine]),&#xD;
               or scheduled within 30 days after last dose of investigational vaccine.&#xD;
  &#xD;
            -  Received a vaccine with adenovirus vector within 6 months prior to the first dose of&#xD;
               investigational vaccine.&#xD;
  &#xD;
            -  Investigator site staff directly involved in the conduct of the study, site staff&#xD;
               otherwise supervised by the investigator, and their respective family members.&#xD;
  &#xD;
            -  Volunteers with or have history of lung function abnormalities such as asthma, chronic&#xD;
               obstructive pulmonary disease, and pulmonary fibrosis.&#xD;
  &#xD;
            -  Current smokers.&#xD;
  &#xD;
            -  History or current evidence of any condition, therapy, or laboratory abnormal values&#xD;
               that are clinically significant which might confound the results of the study,&#xD;
               interfere with the participant's participation for the full duration of the study, or&#xD;
               is not in the best interest of the participants to participate, in the opinion of the&#xD;
               treating investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Scot Halperin, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Canadian Center for Vaccinology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Meixu Yan</last_name>
      <phone>022-58213600-6051</phone>
      <email>meixu.yan@cansinotech.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Canadian Center for Vaccinology</name>
        <address>
          <city>Halifax</city>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Varicella zoster virus</keyword>
    <keyword>Safety</keyword>
    <keyword>Immunogenicity</keyword>
    <keyword>Intramuscular injection</keyword>
    <keyword>Inhalation</keyword>
    <keyword>Vaccine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Herpes Zoster</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vaccines</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05991427
  org study id: CTP-CVE-001
  nct id: NCT05991427
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized, observer blind and controlled study. Participants in low-dose and
        high-dose IM group will be randomized in a ratio of 2:1 to receive either the investigational
        product or the control. Participants in the IH group will receive either inhaled
        investigational product or saline in a ratio of 3:1. Enrollment will be in an ascending order
        of dosage groups. All participants will receive 2 doses in 4 months interval. Blood samples
        will be collected for immunogenicity evaluation over the time course of the study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Incidence of local and systemic reactogenicity within 7 days after each vaccination
  time frame: Within 7 days after each vaccination
  measure: Incidence of Serious Adverse Event (SAE) and Adverse Event of Special Interest (AESI) from the 1st dose to the end of study.
  time frame: From the 1st dose to the end of study
  measure: The unsolicited adverse events for 28 days after each vaccination
  time frame: 28 days after each vaccination
  measure: The blood biochemistry parameters, include Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Basophils (BAS), Creatinine (CREA), Eosinophils (EOS), Fibrinogen (FIBR), Hematocrit (HCT), Hemoglobin (HGB), on day 7 post each vaccination.
  time frame: Day 7 post each vaccination
  measure: The Geometric mean titer (GMT) of gE-specific antibody using Enzyme-linked Immunosorbent Assay (ELISA) over the time course.
  time frame: Through study completion, an average of 8 months
  measure: The GMT of gE-specific antibody 28 days after the 1st and 2nd dose vaccination across each vaccination group.
  time frame: 28 days after the 1st and 2nd dose vaccination
  measure: The gE-specific IFN-γ by EliSpot over the time course of the study
  time frame: Through study completion, an average of 8 months
  arm group label: Experimental vaccine group, low dose, Intramuscular injection(IM)
  arm group type: Experimental
  description: 2 doses of ChAdOX1-VZV vaccine (1 × 10^10 vp) on Day 0 and Month 4
  arm group label: Control vaccine group, low dose, IM
  arm group type: Active Comparator
  description: 2 doses of Shingrix vaccine (0.5ml) on Day 0 and Month 4
  arm group label: Experimental vaccine group, high dose, IM
  arm group type: Experimental
  description: 2 doses of ChAdOX1-VZV vaccine (5 × 10^10 vp) on Day 0 and Month 4
  arm group label: Control vaccine group, high dose, IM
  arm group type: Active Comparator
  description: 2 doses of Shingrix vaccine (0.5ml) on Day 0 and Month 4
  arm group label: Experimental vaccine group, Aerosol, Inhalation(IH)
  arm group type: Experimental
  description: 2 doses of ChAdOX1-VZV vaccine (2 × 10^10 vp) on Day 0 and Month 4
  arm group label: Saline group, Aerosol, IH
  arm group type: Placebo Comparator
  description: 2 doses of saline (0.2ml) on Day 0 and Month 4
  intervention type: Biological
  intervention name: Recombinant Zoster Vaccine (Adenovirus Vector) (ChAdOx1-VZV)
  description: 2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4
  arm group label: Experimental vaccine group, low dose, Intramuscular injection(IM)
  intervention type: Biological
  intervention name: Zoster Vaccine Recombinant, Adjuvanted (Shingrix)
  description: 2 doses of Shingrix vaccine on Day 0 and Month 4
  arm group label: Control vaccine group, low dose, IM
  intervention type: Biological
  intervention name: ChAdOx1-VZV
  description: 2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4
  arm group label: Experimental vaccine group, high dose, IM
  intervention type: Biological
  intervention name: Shingrix
  description: 2 doses of Shingrix vaccine on Day 0 and Month 4
  arm group label: Control vaccine group, high dose, IM
  intervention type: Biological
  intervention name: IH ChAdOx1-VZV
  description: 2 doses of ChAdOX1-VZV vaccine on Day 0 and Month 4
  arm group label: Experimental vaccine group, Aerosol, Inhalation(IH)
  intervention type: Biological
  intervention name: IH saline
  description: 2 doses of saline on Day 0 and Month 4
  arm group label: Saline group, Aerosol, IH
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Scot Halperin, MD
  role: Principal Investigator
  affiliation: Canadian Center for Vaccinology
  last name: Meixu Yan
  phone: 022-58213600-6051
  email: meixu.yan@cansinotech.com
  facility: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Herpes Zoster
  mesh term: Vaccines