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/NCT05982314</url>
    </required_header>
    <id_info>
      <org_study_id>GPNV-002</org_study_id>
      <nct_id>NCT05982314</nct_id>
    </id_info>
    <brief_title>Extension Safety and Immunogenicity Study of GPNV-001</brief_title>
    <official_title>A Safety and Immunogenicity Extension Study of GPNV-001</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>GPN Vaccines</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>GPN Vaccines</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>
        A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel&#xD;
        whole-cell pneumococcal vaccine.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel&#xD;
        whole-cell pneumococcal vaccine. Up to 20 participants per cohort will be invited.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 17, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <phase>Phase 1/Phase 2</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>Serum IgG titre to Gamma-PN3</measure>
      <time_frame>6 months and 12 months</time_frame>
      <description>Serum IgG titre to the vaccine</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serious adverse events</measure>
      <time_frame>6 months and 12 months</time_frame>
      <description>Serious adverse events occurring after day 57 of study GPNV-001</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Opsonophagocytic antibodies to pneumococcal strains</measure>
      <time_frame>6 months and 12 months</time_frame>
      <description>Serum OPA titres to up to 24 pneumococcal serotypes</description>
    </secondary_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Pneumococcal Infections</condition>
    <arm_group>
      <arm_group_label>Gamma-PN3 50 mcg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In GPNV-001 participants will have received 2 doses of 50 mcg Gamma-PN3 at intervals of 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Gamma-PN3 250 mcg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In GPNV-001 participants will have received 2 doses of 250 mcg Gamma-PN3 at intervals of 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Gamma-PN3 1000 mcg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In GPNV-001 participants will have received 2 doses of 1000 mcg Gamma-PN3 at intervals of 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pneumovax 23</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In GPNV-001 participants will have received one 0.5ml dose of Pneumovax-23 followed by saline placebo 4 weeks later</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Prevenar-13</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In GPNV-001 participants will have received one 0.5ml dose of Prevenar-13 followed by saline placebo 4 weeks later</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>In GPNV-001 participants will have received two doses of 0.5 ml saline placebo at intervals of 4 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Gamma-PN3</intervention_name>
      <description>Experimental whole-cell pneumococcal vaccine</description>
      <arm_group_label>Gamma-PN3 1000 mcg</arm_group_label>
      <arm_group_label>Gamma-PN3 250 mcg</arm_group_label>
      <arm_group_label>Gamma-PN3 50 mcg</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Pneumovax-23</intervention_name>
      <description>Licensed pneumococcal vaccine</description>
      <arm_group_label>Pneumovax 23</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Prevenar-13</intervention_name>
      <description>Licensed pneumococcal vaccine</description>
      <arm_group_label>Prevenar-13</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Saline placebo</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Completion of study GPNV-001 as per protocol with no significant deviations.&#xD;
  &#xD;
            2. Has provided written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Potential participants will be excluded if they have received a pneumococcal vaccine&#xD;
               since the end of study visit for study GPNV-001&#xD;
  &#xD;
            2. A potential participant has had an episode of pneumonia since completing Study&#xD;
               GPNV-001&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>69 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Paul Rolan, MD</last_name>
      <phone>+61 405 670 420</phone>
      <email>paul@gpnvaccines.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tim Hirst, PhD</last_name>
      <phone>+61 420 942 824</phone>
      <email>tim@gpnvaccines.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Adelaide</name>
        <address>
          <city>Adelaide</city>
          <state>South Australia</state>
          <zip>5005</zip>
          <country>Australia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kelly Harris, BSc</last_name>
        <phone>+61-8-7088 7900</phone>
        <email>kelly.harris@cmax.com.au</email>
      </contact>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 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>Pneumococcal Infections</mesh_term>
    </condition_browse>
    <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>
      <ipd_description>No plan as yet</ipd_description>
    </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/NCT05982314
  org study id: GPNV-002
  nct id: NCT05982314
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel
        whole-cell pneumococcal vaccine.
  A 6 and 12 month safety and immunogenicity study of participants in study GPNV-001, a novel
        whole-cell pneumococcal vaccine. Up to 20 participants per cohort will be invited.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Serum IgG titre to Gamma-PN3
  time frame: 6 months and 12 months
  description: Serum IgG titre to the vaccine
  measure: Serious adverse events
  time frame: 6 months and 12 months
  description: Serious adverse events occurring after day 57 of study GPNV-001
  measure: Opsonophagocytic antibodies to pneumococcal strains
  time frame: 6 months and 12 months
  description: Serum OPA titres to up to 24 pneumococcal serotypes
  arm group label: Gamma-PN3 50 mcg
  arm group type: Experimental
  description: In GPNV-001 participants will have received 2 doses of 50 mcg Gamma-PN3 at intervals of 4 weeks
  arm group label: Gamma-PN3 250 mcg
  arm group type: Experimental
  description: In GPNV-001 participants will have received 2 doses of 250 mcg Gamma-PN3 at intervals of 4 weeks
  arm group label: Gamma-PN3 1000 mcg
  arm group type: Experimental
  description: In GPNV-001 participants will have received 2 doses of 1000 mcg Gamma-PN3 at intervals of 4 weeks
  arm group label: Pneumovax 23
  arm group type: Active Comparator
  description: In GPNV-001 participants will have received one 0.5ml dose of Pneumovax-23 followed by saline placebo 4 weeks later
  arm group label: Prevenar-13
  arm group type: Active Comparator
  description: In GPNV-001 participants will have received one 0.5ml dose of Prevenar-13 followed by saline placebo 4 weeks later
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: In GPNV-001 participants will have received two doses of 0.5 ml saline placebo at intervals of 4 weeks.
  intervention type: Biological
  intervention name: Gamma-PN3
  description: Experimental whole-cell pneumococcal vaccine
  arm group label: Gamma-PN3 1000 mcg
  arm group label: Gamma-PN3 250 mcg
  arm group label: Gamma-PN3 50 mcg
  intervention type: Biological
  intervention name: Pneumovax-23
  description: Licensed pneumococcal vaccine
  arm group label: Pneumovax 23
  intervention type: Biological
  intervention name: Prevenar-13
  description: Licensed pneumococcal vaccine
  arm group label: Prevenar-13
  intervention type: Biological
  intervention name: Placebo
  description: Saline placebo
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 69 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Paul Rolan, MD
  phone: +61 405 670 420
  email: paul@gpnvaccines.com
  last name: Tim Hirst, PhD
  phone: +61 420 942 824
  email: tim@gpnvaccines.com
  facility: 
  status: Recruiting
  contact: 
  country: Australia
  responsible party type: Sponsor
  mesh term: Pneumococcal Infections
  mesh term: Heptavalent Pneumococcal Conjugate Vaccine
  sharing ipd: No
  ipd description: No plan as yet