<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20140818018842N22</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-12</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the COVID-19 vaccine efficacy following allogeneic stem cell transplantation</public_title>
      <acronym>ESVIRHSCT</acronym>
      <scientific_title>Evaluation of safety and immunogenicity of the SARS-CoV-2 recombinant spike RBD protein vaccine in Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation; A phase 2 clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61044</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>2</phase>
      <hc_freetext>Allogeneic stem cells transplantation.</hc_freetext>
      <i_freetext>All consecutive adult patients who are candidates for Allo-HSCT at HORCSCT are recruited. They sign an informed consent to administer the Pastocovac vaccine and take blood samples. All patients who meet the inclusion criteria are enrolled to study from 3 to 12 months after Allo-HSCT and will be vaccinated with the first two doses of Pastucovac at a 4-week (±7 days) interval and a third additional dose with an 8-week (±7 days) interval from the second dose. Peripheral blood samples are collected before conditioning and before the first dose of vaccine to test particular lymphocyte subpopulations and SARS-CoV-2 IgG titers. The blood samples are also collected three weeks (± one week) after each dose of vaccine to assess serologic response by SARS-CoV-2 IgG titer..</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leyla Sharifi Aliabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital, North Kargar Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417713135</zip>
        <telephone>00982288004140</telephone>
        <email>ctu@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Barkhordar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital, North Kargar Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 8490 2635</telephone>
        <email>mbarkhordar@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Allogeneic stem cell transplantation
successfully engraftment with full donor chimerism
Age &gt;=18
between 3 to 12 months after Allo-HSCT</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>grade 3,4 acute GvHD or severe extensive chronic GvHD
Patients who do not consent to vaccination after transplantation
receive more than 0.5 mg/kg/day prednisolone
positive RT-PCR test for COVID-19 during the last three months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z94.84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stem cells transplant status</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>All consecutive adult patients who are candidates for Allo-HSCT at HORCSCT are recruited. They sign an informed consent to administer the Pastocovac vaccine and take blood samples. All patients who meet the inclusion criteria are enrolled to study from 3 to 12 months after Allo-HSCT and will be vaccinated with the first two doses of Pastucovac at a 4-week (±7 days) interval and a third additional dose with an 8-week (±7 days) interval from the second dose. Peripheral blood samples are collected before conditioning and before the first dose of vaccine to test particular lymphocyte subpopulations and SARS-CoV-2 IgG titers. The blood samples are also collected three weeks (± one week) after each dose of vaccine to assess serologic response by SARS-CoV-2 IgG titer.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>SARS-CoV-2 specific IgG (anti-S1) titer. Timepoint: four weeks after the second vaccine. Method of measurement: ٍٍEnzyme-linked immunosorbent assay.</prim_outcome>
      <prim_outcome>B lymphocyte count. Timepoint: Three months after allogeneic transplantation. Method of measurement: multicolor flow cytometry.</prim_outcome>
      <prim_outcome>NK cell count. Timepoint: Three months after allogeneic transplantation. Method of measurement: multicolor flow cytometry.</prim_outcome>
      <prim_outcome>T cell count. Timepoint: Three months after allogeneic transplantation. Method of measurement: multicolor flow cytometry.</prim_outcome>
      <prim_outcome>Cumulative incidence of COVID-19. Timepoint: 12 months following bone marrow transplantation. Method of measurement: RT-PCR test.</prim_outcome>
      <prim_outcome>Acute graft versus host disease. Timepoint: 100 days following bone marrow transplantation. Method of measurement: Physical exam, biopsy, lab test.</prim_outcome>
      <prim_outcome>Overall survival. Timepoint: 12 months following bone marrow transplantation. Method of measurement: electronic data bank.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Overall survival. Timepoint: One-year post transplantation. Method of measurement: Time.</sec_outcome>
      <sec_outcome>Acute Graft versus Host Disease. Timepoint: 100 days post-transplantation. Method of measurement: physical exam, lab test, and biopsy.</sec_outcome>
      <sec_outcome>Relapse. Timepoint: One-year post-transplantation. Method of measurement: bone marrow aspiration and biopsy.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Pasture Institute of Iran</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
      <source_name>Pasture Institute of Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-29</approval_date>
        <contact_name>Ethic committee of Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran Univer</contact_name>
        <contact_address>Kargar shomali Ave., Shariati hospital Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
