<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/NCT02232191</url>
  </required_header>
  <id_info>
    <org_study_id>1036320</org_study_id>
    <secondary_id>51847</secondary_id>
    <nct_id>NCT02232191</nct_id>
  </id_info>
  <brief_title>Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients</brief_title>
  <official_title>Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Persons without a spleen are susceptible to potentially lethal infections from certain&#xD;
      bacteria, with pneumococcus being the most prevalent. Vaccines are provided to help protect&#xD;
      against these infections, though they do not so with certainty. Trauma patients who sustain&#xD;
      an injury to their spleen currently have three treatment options available for the treating&#xD;
      surgeon - nonoperative management, embolization, or removal of the spleen. The purpose of&#xD;
      this study is to investigate the antibody response to pneumococcal vaccine in patients&#xD;
      undergoing these modes of therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a multi-institutional, prospective trial, conducted primarily at the University&#xD;
      of California, Davis Medical Center (UCDMC) by the Department of Surgery, Division of Trauma&#xD;
      and Acute Care Surgery. The angioembolization arm will be multicenter while the nonoperative&#xD;
      group will be enrolled only at UCDMC. There will be a total of 75 subjects, with 25 in each&#xD;
      of the three arms (nonoperative, angioembolization, splenectomy).&#xD;
&#xD;
      Adult trauma patients (defined as those aged 18 to 65 years old) sustaining a splenic injury&#xD;
      and planned nonoperative management, are eligible for enrollment in the nonoperative arm. The&#xD;
      management decision for the splenic injury is entirely at the discretion of the attending&#xD;
      trauma surgeon. Any patient who subsequently undergoes embolization or splenectomy will be&#xD;
      withdrawn from the study.&#xD;
&#xD;
      Adult trauma patients sustaining a splenic injury and undergoing splenic artery embolization&#xD;
      are eligible for enrollment in this arm of the study. The management decision for the splenic&#xD;
      injury is entirely at the discretion of the attending trauma surgeon and radiologist. All&#xD;
      patients undergoing successful splenic artery embolization (no subsequent splenectomy or&#xD;
      splenorrhaphy, i.e., no cross-over) are eligible.&#xD;
&#xD;
      Patients managed nonoperatively will be vaccinated within three days of their diagnosis, per&#xD;
      standard operating protocol at UCDMC. At the time of vaccination, 7cc of venous blood will be&#xD;
      collected for baseline antibody analysis. Patients will return four weeks later for a&#xD;
      follow-up phlebotomy of another 7cc of blood for analysis of functional antipneumococcal&#xD;
      antibody generated in response to vaccine antigen challenge. Blood samples will be&#xD;
      centrifuged and stored, and stored sera will be sent in batches on dry ice to Flow&#xD;
      Applications, Inc. in McDonough, Georgia for antibody analysis. All samples will be assigned&#xD;
      unique patient identifiers.&#xD;
&#xD;
      Responses to the 23-valent pneumococcal polysaccharide vaccine will be measured by ELISA to&#xD;
      determine the geometric mean increase in immunoglobulin G (IgG) antibody titer to&#xD;
      pneumococcal polysaccharide (Pnc Ps) serotypes. Functional antibody, measured by percent kill&#xD;
      of a known pneumococcal concentration, will be determined by opsonophagocytosis assay (OPA).&#xD;
      Titers for serogroup 4 and serotypes 6B, 19F, and 23F will be measured, and geometric mean&#xD;
      rises in antibody concentrations will be determined to measure response to vaccination.&#xD;
&#xD;
      For those treated with nonoperative management, degree of antibody response and grade of&#xD;
      splenic injury will be analyzed against normal controls.&#xD;
&#xD;
      Patients treated via splenic artery embolization will undergo a standard post-embolization&#xD;
      computed tomographic exam of the abdomen three to five days postinjury to evaluate the&#xD;
      effectiveness of the embolization procedure. The percent of viable, perfused spleen will be&#xD;
      calculated from this CT. Antibody response will be compared against the location of the&#xD;
      intravascular coils (i.e., proximal versus distal embolization) and the percent of viable&#xD;
      spleen as calculated on the follow-up CT scan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">March 2, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Geometric mean increases in pneumococcal antibody titer</measure>
    <time_frame>4 weeks</time_frame>
    <description>measured by opsonophagocytosis assay</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Asplenia</condition>
  <arm_group>
    <arm_group_label>Nonoperative</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pneumococcal vaccine (Pneumovax-23) will be administered within 72 hours of injury. Baseline antibody levels will be drawn at the time of vaccine administration, with response levels being drawn 4 weeks later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Angioembolization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pneumococcal vaccine (Pneumovax-23) will be administered 14 days after embolization. Baseline antibody levels will be drawn at the time of vaccine administration, with response levels being drawn 4 weeks later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Splenectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pneumococcal vaccine (Pneumovax-23) will be administered 14 days after splenectomy. Baseline antibody levels will be drawn at the time of vaccine administration, with response levels being drawn 4 weeks later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pneumovax-23</intervention_name>
    <arm_group_label>Angioembolization</arm_group_label>
    <arm_group_label>Nonoperative</arm_group_label>
    <arm_group_label>Splenectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult trauma patients (aged 18 to 65 years old) sustaining a splenic injury.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ages less than 18 and greater than 65&#xD;
&#xD;
          -  Initial planned nonoperative management patient who subsequently undergoes&#xD;
             embolization or splenectomy will be withdrawn from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Shatz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David V Shatz, MD</last_name>
    <phone>916-734-5535</phone>
    <email>dvshatz@ucdavis.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anthony Calabro, PhD</last_name>
    <phone>916-734-4365</phone>
    <email>arcalabro@ucdavis.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of California, Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David V Shatz, MD</last_name>
      <email>dvshatz@ucdavis.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://studypages.com/s/study-of-immune-response-to-pneumococcal-vaccine-in-splenic-injury-patients-999760/</url>
    <description>Learn more or sign up for the study here!</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>June 15, 2023</last_update_submitted>
  <last_update_submitted_qc>June 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heptavalent Pneumococcal Conjugate Vaccine</mesh_term>
  </intervention_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/NCT02232191
org study id: 1036320
secondary id: 51847
nct id: NCT02232191
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Persons without a spleen are susceptible to potentially lethal infections from certain
      bacteria, with pneumococcus being the most prevalent. Vaccines are provided to help protect
      against these infections, though they do not so with certainty. Trauma patients who sustain
      an injury to their spleen currently have three treatment options available for the treating
      surgeon - nonoperative management, embolization, or removal of the spleen. The purpose of
      this study is to investigate the antibody response to pneumococcal vaccine in patients
      undergoing these modes of therapy.
The study is a multi-institutional, prospective trial, conducted primarily at the University
      of California, Davis Medical Center (UCDMC) by the Department of Surgery, Division of Trauma
      and Acute Care Surgery. The angioembolization arm will be multicenter while the nonoperative
      group will be enrolled only at UCDMC. There will be a total of 75 subjects, with 25 in each
      of the three arms (nonoperative, angioembolization, splenectomy).

      Adult trauma patients (defined as those aged 18 to 65 years old) sustaining a splenic injury
      and planned nonoperative management, are eligible for enrollment in the nonoperative arm. The
      management decision for the splenic injury is entirely at the discretion of the attending
      trauma surgeon. Any patient who subsequently undergoes embolization or splenectomy will be
      withdrawn from the study.

      Adult trauma patients sustaining a splenic injury and undergoing splenic artery embolization
      are eligible for enrollment in this arm of the study. The management decision for the splenic
      injury is entirely at the discretion of the attending trauma surgeon and radiologist. All
      patients undergoing successful splenic artery embolization (no subsequent splenectomy or
      splenorrhaphy, i.e., no cross-over) are eligible.

      Patients managed nonoperatively will be vaccinated within three days of their diagnosis, per
      standard operating protocol at UCDMC. At the time of vaccination, 7cc of venous blood will be
      collected for baseline antibody analysis. Patients will return four weeks later for a
      follow-up phlebotomy of another 7cc of blood for analysis of functional antipneumococcal
      antibody generated in response to vaccine antigen challenge. Blood samples will be
      centrifuged and stored, and stored sera will be sent in batches on dry ice to Flow
      Applications, Inc. in McDonough, Georgia for antibody analysis. All samples will be assigned
      unique patient identifiers.

      Responses to the 23-valent pneumococcal polysaccharide vaccine will be measured by ELISA to
      determine the geometric mean increase in immunoglobulin G (IgG) antibody titer to
      pneumococcal polysaccharide (Pnc Ps) serotypes. Functional antibody, measured by percent kill
      of a known pneumococcal concentration, will be determined by opsonophagocytosis assay (OPA).
      Titers for serogroup 4 and serotypes 6B, 19F, and 23F will be measured, and geometric mean
      rises in antibody concentrations will be determined to measure response to vaccination.

      For those treated with nonoperative management, degree of antibody response and grade of
      splenic injury will be analyzed against normal controls.

      Patients treated via splenic artery embolization will undergo a standard post-embolization
      computed tomographic exam of the abdomen three to five days postinjury to evaluate the
      effectiveness of the embolization procedure. The percent of viable, perfused spleen will be
      calculated from this CT. Antibody response will be compared against the location of the
      intravascular coils (i.e., proximal versus distal embolization) and the percent of viable
      spleen as calculated on the follow-up CT scan.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Geometric mean increases in pneumococcal antibody titer
time frame: 4 weeks
description: measured by opsonophagocytosis assay
arm group label: Nonoperative
arm group type: Active Comparator
description: Pneumococcal vaccine (Pneumovax-23) will be administered within 72 hours of injury. Baseline antibody levels will be drawn at the time of vaccine administration, with response levels being drawn 4 weeks later.
arm group label: Angioembolization
arm group type: Active Comparator
description: Pneumococcal vaccine (Pneumovax-23) will be administered 14 days after embolization. Baseline antibody levels will be drawn at the time of vaccine administration, with response levels being drawn 4 weeks later.
arm group label: Splenectomy
arm group type: Active Comparator
description: Pneumococcal vaccine (Pneumovax-23) will be administered 14 days after splenectomy. Baseline antibody levels will be drawn at the time of vaccine administration, with response levels being drawn 4 weeks later.
intervention type: Biological
intervention name: Pneumovax-23
arm group label: Angioembolization
arm group label: Nonoperative
arm group label: Splenectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: David Shatz, MD
role: Principal Investigator
affiliation: University of California, Davis
last name: David V Shatz, MD
phone: 916-734-5535
email: dvshatz@ucdavis.edu
last name: Anthony Calabro, PhD
phone: 916-734-4365
email: arcalabro@ucdavis.edu
facility: 
status: Recruiting
contact: 
country: United States
url: https://studypages.com/s/study-of-immune-response-to-pneumococcal-vaccine-in-splenic-injury-patients-999760/
description: Learn more or sign up for the study here!
responsible party type: Sponsor
mesh term: Heptavalent Pneumococcal Conjugate Vaccine
sharing ipd: No