<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/NCT04403139</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00009255</org_study_id>
    <secondary_id>R01AG064800</secondary_id>
    <nct_id>NCT04403139</nct_id>
  </id_info>
  <brief_title>VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination</brief_title>
  <official_title>VZV-specific Tissue Resident Memory T-cells After Shingrix Vaccination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effect of intramuscular RZV vaccine on VZV-specific skin TRM and circulating&#xD;
      T-cells&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an interventional study of vaccination related to infection with varicella zoster&#xD;
      virus. We will enroll participants of two age groups. Cohort 1 will be persons between the&#xD;
      ages of 30-40; Cohort 2 will be persons who are 70 years of age or older. All participants&#xD;
      will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the&#xD;
      approved dose and schedule.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 27, 2022</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of gE-specific IgG in serum.</measure>
    <time_frame>up to 1 year after vaccination</time_frame>
    <description>Units will be optical density at 492 nanometers from ELISA.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of gE-specific CD4 T cells in blood</measure>
    <time_frame>up to 1 year after vaccination</time_frame>
    <description>Units will be cells per million CD4+ T cells in blood.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cytokine profile of gE-specific CD4 T cells in blood</measure>
    <time_frame>up to 1 year after vaccination</time_frame>
    <description>Units will be percent of gE-reactive T cells expressing single T cell cytokines or combinations of cytokines</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Varicella Zoster Virus Infection</condition>
  <arm_group>
    <arm_group_label>Cohort 1: 30-40 year of age</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: 70 years of age or older</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Shingrix</intervention_name>
    <description>All participants will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the approved dose and schedule.</description>
    <arm_group_label>Cohort 1: 30-40 year of age</arm_group_label>
    <arm_group_label>Cohort 2: 70 years of age or older</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cohort 1: 30-40 years of age&#xD;
&#xD;
          -  Cohort 2: 70 years of age or older&#xD;
&#xD;
          -  HIV seronegative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous vaccination with Shingrix (RZV), Zostavax (ZVL, zoster vaccine live), or with&#xD;
             the chickenpox vaccine&#xD;
&#xD;
          -  VZV seronegative&#xD;
&#xD;
          -  Active Hepatitis C infection or active Hepatitis B infection. Persons with serologic&#xD;
             evidence of hepatitis C infection that has cleared spontaneously, or with a history of&#xD;
             treated hepatitis C with a sustained virologic response, can be enrolled. Persons with&#xD;
             a history of resolved hepatitis B infection (negative for hepatitis B surface antigen)&#xD;
             can be enrolled&#xD;
&#xD;
          -  History of a life-threatening allergic reaction (anaphylactic/anaphylactoid reaction)&#xD;
             to any component of the vaccine&#xD;
&#xD;
          -  History of receipt of an organ transplant or hematopoietic stem cell transplant&#xD;
&#xD;
          -  Significant autoimmune disease such as rheumatoid arthritis, psoriatic arthritis,&#xD;
             inflammatory bowel disease, multiple sclerosis, scleroderma, dermatomyositis, or other&#xD;
             condition which in the past has required significant immune modifying medication or&#xD;
             which has a clinical course that is characterized by relapses&#xD;
&#xD;
          -  Has immunosuppression as a result of an underlying illness (e.g. leukemia, lymphoma or&#xD;
             other malignant neoplasms) or treatment with immunosuppressive or cytotoxic drugs, or&#xD;
             use of anticancer chemotherapy or radiation therapy.&#xD;
&#xD;
          -  Has long-term use of oral or parenteral steroids (&gt;7 days), or high-dose inhaled&#xD;
             steroids (&gt;800 mcg/day of beclomethasone dipropionate or equivalent) within the&#xD;
             preceding 6 months (nasal and topical steroids are allowed)&#xD;
&#xD;
          -  Women of child-bearing potential only: pregnant, breastfeeding, or planning to become&#xD;
             pregnant 3 months post vaccination&#xD;
&#xD;
          -  Has an acute or chronic medical condition that, in the opinion of the investigator,&#xD;
             would render biopsies unsafe&#xD;
&#xD;
          -  History of coagulopathy or taking medication that may cause bleeding (long term high&#xD;
             dose aspirin, heparin, coumadin). Aspirin doses &lt;100 mg daily allowed&#xD;
&#xD;
          -  History of keloid formation or excessive scarring&#xD;
&#xD;
          -  History of frequent cellulitis or boils (&gt;3 episodes in past 2 years) requiring&#xD;
             antibiotic therapy&#xD;
&#xD;
          -  Allergy to lidocaine, silver nitrate, or mupirocin&#xD;
&#xD;
          -  Has any condition or medical history that would, in the opinion of the site principal&#xD;
             investigator place the subject at an unacceptable risk of injury or render the subject&#xD;
             unable to meet the requirements of the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine M Johnston, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Virology Research Clinic</last_name>
    <phone>206-520-4340</phone>
    <email>vrc@uw.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Washington Virology Research Clinic</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>206-520-4340</phone>
      <email>vrc@u.washington.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>December 15, 2022</last_update_submitted>
  <last_update_submitted_qc>December 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Christine Johnston</investigator_full_name>
    <investigator_title>Associate Professor: School of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Herpes Zoster</mesh_term>
    <mesh_term>Varicella Zoster Virus Infection</mesh_term>
  </condition_browse>
  <!-- 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/NCT04403139
org study id: STUDY00009255
secondary id: R01AG064800
nct id: NCT04403139
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
To evaluate the effect of intramuscular RZV vaccine on VZV-specific skin TRM and circulating
      T-cells
This is an interventional study of vaccination related to infection with varicella zoster
      virus. We will enroll participants of two age groups. Cohort 1 will be persons between the
      ages of 30-40; Cohort 2 will be persons who are 70 years of age or older. All participants
      will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the
      approved dose and schedule.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Level of gE-specific IgG in serum.
time frame: up to 1 year after vaccination
description: Units will be optical density at 492 nanometers from ELISA.
measure: Level of gE-specific CD4 T cells in blood
time frame: up to 1 year after vaccination
description: Units will be cells per million CD4+ T cells in blood.
measure: Cytokine profile of gE-specific CD4 T cells in blood
time frame: up to 1 year after vaccination
description: Units will be percent of gE-reactive T cells expressing single T cell cytokines or combinations of cytokines
arm group label: Cohort 1: 30-40 year of age
arm group type: Other
arm group label: Cohort 2: 70 years of age or older
arm group type: Other
intervention type: Drug
intervention name: Shingrix
description: All participants will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the approved dose and schedule.
arm group label: Cohort 1: 30-40 year of age
arm group label: Cohort 2: 70 years of age or older
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christine M Johnston, MD, MPH
role: Principal Investigator
affiliation: University of Washington
last name: Virology Research Clinic
phone: 206-520-4340
email: vrc@uw.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Christine Johnston
investigator title: Associate Professor: School of Medicine
mesh term: Herpes Zoster
mesh term: Varicella Zoster Virus Infection