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/NCT06001606</url>
    </required_header>
    <id_info>
      <org_study_id>H-2303-017-1410</org_study_id>
      <nct_id>NCT06001606</nct_id>
    </id_info>
    <brief_title>Immunogenicity, Reactogenicity of Shingrix in SLE</brief_title>
    <official_title>Immunogenicity, Reactogenicity and Safety of 2 Doses of an Adjuvanted Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus: a Randomized Clinical Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Seoul National University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To investigate the immunogenicity, reactogenicity and safety of 2 doses of the adjuvanted&#xD;
        herpes zoster subunit vaccine (Shingrix) in patients with SLE in a randomized trial.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 8, 2023</start_date>
    <completion_date type="Anticipated">April 24, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 24, 2025</primary_completion_date>
    <phase>Phase 3</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>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Frequency of positive humoral vaccine response at 1 month post-dose 2</measure>
      <time_frame>3 months</time_frame>
      <description>Proporition of pariticpants who achieved a ≥4-fold increase in the anti-gE antibody concentration as compared to the prevaccination concentration</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Frequency of positive humoral vaccine response at 6 months post-dose 2</measure>
      <time_frame>8 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequency of humoral responses 12 month post-dose 2</measure>
      <time_frame>14 month</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-gE antibody concentration at 6 months post-dose 2</measure>
      <time_frame>8 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-gE antibody concentration at 12 months post-dose 2</measure>
      <time_frame>14 months</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>SLE flare rate</measure>
      <time_frame>up to 2 months</time_frame>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">63</enrollment>
    <condition>Zoster</condition>
    <condition>Systemic Lupus Erythematosus</condition>
    <condition>Vaccine Reaction</condition>
    <arm_group>
      <arm_group_label>Shingrix</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Shingrix</intervention_name>
      <description>Shingrix vaccination</description>
      <arm_group_label>Shingrix</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo vaccination</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males or females ≥ 19 years of age at time of consent&#xD;
  &#xD;
            -  ≥4 of the 1997 ACR13 or the 2012 SLICC/ACR criteria for SLE (13, 14)&#xD;
  &#xD;
            -  Clinically stable SLE&#xD;
  &#xD;
            -  Corticosteroid use: ≥ 5mg/day of prednisolone equivalent&#xD;
  &#xD;
            -  Stable dose of one or more of the following immunosuppressive treatment ≥ 4 weeks&#xD;
  &#xD;
                 -  Antimalarials (≤400 mg/day)&#xD;
  &#xD;
                 -  Azathioprine (≤3 mg/kg/day)&#xD;
  &#xD;
                 -  Mycophenolate mofetil (≤3 mg/day)&#xD;
  &#xD;
                 -  Tacrolimus (≤5mg/day)&#xD;
  &#xD;
                 -  Methotrexate (≤20mg/week)&#xD;
  &#xD;
                 -  Cyclosphosphamide (≤1mg/BSA/month)&#xD;
  &#xD;
            -  Must understand and voluntarily sign an informed consent form including writing&#xD;
               consent for data protection&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or lactating females&#xD;
  &#xD;
            -  Acute infection with T &gt;38°C at the time of vaccination&#xD;
  &#xD;
            -  Previous anaphylactic response to vaccine components or to egg&#xD;
  &#xD;
            -  History of Guillain-Barre syndrome or demyelinating syndromes&#xD;
  &#xD;
            -  Any condition including laboratory abnormality which places the subject at&#xD;
               unacceptable risk&#xD;
  &#xD;
            -  Subjects who decline to participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jin Kyun Park, MD</last_name>
      <phone>82-2-2072-4765</phone>
      <email>jinkyunpark@snu.ac.kr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Seoul National University Hospital</name>
        <address>
          <city>Seoul</city>
          <zip>03080</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eun Bong Lee, MD PhD</last_name>
        <phone>82-2-2072-3944</phone>
        <email>leb7616@snu.ac.kr</email>
      </contact>
      <contact_backup>
        <last_name>Ju Yeon Kim, MD</last_name>
        <phone>82-2-2072-2957</phone>
        <email>simple0693@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <results_reference>
      <citation>Park JK, Lee YJ, Shin K, Kang EH, Ha YJ, Park JW, Kim MJ, Kim MH, Choi SR, Jung Y, Lee JH, In Jung J, Kim JY, Winthrop KL, Lee EB. A Multicenter, Prospective, Randomized, Parallel-Group Trial on the Effects of Temporary Methotrexate Discontinuation for One Week Versus Two Weeks on Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2023 Feb;75(2):171-177. doi: 10.1002/art.42318. Epub 2022 Dec 7.</citation>
      <PMID>35930728</PMID>
    </results_reference>
    <results_reference>
      <citation>Park JK, Lee MA, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2017 Sep;76(9):1559-1565. doi: 10.1136/annrheumdis-2017-211128. Epub 2017 May 3.</citation>
      <PMID>28468794</PMID>
    </results_reference>
    <results_reference>
      <citation>Park JK, Lee YJ, Shin K, Ha YJ, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2018 Jun;77(6):898-904. doi: 10.1136/annrheumdis-2018-213222. Epub 2018 Mar 23.</citation>
      <PMID>29572291</PMID>
    </results_reference>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>May 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Herpes Zoster</mesh_term>
      <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06001606
  org study id: H-2303-017-1410
  nct id: NCT06001606
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To investigate the immunogenicity, reactogenicity and safety of 2 doses of the adjuvanted
        herpes zoster subunit vaccine (Shingrix) in patients with SLE in a randomized trial.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Frequency of positive humoral vaccine response at 1 month post-dose 2
  time frame: 3 months
  description: Proporition of pariticpants who achieved a ≥4-fold increase in the anti-gE antibody concentration as compared to the prevaccination concentration
  measure: Frequency of positive humoral vaccine response at 6 months post-dose 2
  time frame: 8 months
  measure: Frequency of humoral responses 12 month post-dose 2
  time frame: 14 month
  measure: Anti-gE antibody concentration at 6 months post-dose 2
  time frame: 8 months
  measure: Anti-gE antibody concentration at 12 months post-dose 2
  time frame: 14 months
  measure: SLE flare rate
  time frame: up to 2 months
  arm group label: Shingrix
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Shingrix
  description: Shingrix vaccination
  arm group label: Shingrix
  intervention type: Drug
  intervention name: Placebo
  description: Placebo vaccination
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jin Kyun Park, MD
  phone: 82-2-2072-4765
  email: jinkyunpark@snu.ac.kr
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Korea, Republic of
  citation: Park JK, Lee YJ, Shin K, Kang EH, Ha YJ, Park JW, Kim MJ, Kim MH, Choi SR, Jung Y, Lee JH, In Jung J, Kim JY, Winthrop KL, Lee EB. A Multicenter, Prospective, Randomized, Parallel-Group Trial on the Effects of Temporary Methotrexate Discontinuation for One Week Versus Two Weeks on Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2023 Feb;75(2):171-177. doi: 10.1002/art.42318. Epub 2022 Dec 7.
  PMID: 35930728
  citation: Park JK, Lee MA, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2017 Sep;76(9):1559-1565. doi: 10.1136/annrheumdis-2017-211128. Epub 2017 May 3.
  PMID: 28468794
  citation: Park JK, Lee YJ, Shin K, Ha YJ, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2018 Jun;77(6):898-904. doi: 10.1136/annrheumdis-2018-213222. Epub 2018 Mar 23.
  PMID: 29572291
  responsible party type: Sponsor
  mesh term: Herpes Zoster
  mesh term: Lupus Erythematosus, Systemic
  sharing ipd: No