<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/NCT03026348</url>
  </required_header>
  <id_info>
    <org_study_id>RSV-E-205</org_study_id>
    <nct_id>NCT03026348</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults</brief_title>
  <official_title>Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novavax</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novavax</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, observer-blind, trial in clinically-stable older adults. Up to 300&#xD;
      eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into&#xD;
      multiple dose/formulation treatment arms. Safety and immunogenicity data through Day 56 will&#xD;
      be used to select a vaccine candidate to potentially evaluate in a Part 2 study. Proportions&#xD;
      of subjects in various strata will not be pre-specified and the goal will be to achieve an&#xD;
      approximately equal distribution of subjects with these characteristics across the treatment&#xD;
      groups. Serology measures consistent with the study outcomes will be reported.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">May 18, 2018</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <phase>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>Neutralizing antibody titers to at least one RSV/A strain</measure>
    <time_frame>Day 0, 21, 28</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjects with solicited local and systemic AEs occurring within the 7-day period following dosings on Day 0 and Day 21 and all adverse events, solicited and unsolicited, occurring within the 56-day period of Day 0.</measure>
    <time_frame>Day 0 - Day 6, Day 21 - Day 27; Day 0 - Day 56</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum concentrations of antibodies competitive with palivizumab (i.e., PCA) for binding to the RSV F protein.</measure>
    <time_frame>Day 0, 21, 28, 56, 119, 385</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.</measure>
    <time_frame>Day 0, 21, 28, 56, 119, 385</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Counts of IFN-γ spot forming units following in vitro stimulation of Day 0, Day 7, and Day 28 PBMC isolates with RSV F peptides.</measure>
    <time_frame>Day 0, 7, 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Counts and proportions of Day 0, Day 7, and Day 28 peripheral blood T cells positive by intracellular staining for IL-2, IFN-γ, or TNF-α production (alone or any combination thereof) following in vitro stimulation with RSV F peptides.</measure>
    <time_frame>Day 0, 7, 28</time_frame>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Respiratory Syncytial Viruses</condition>
  <arm_group>
    <arm_group_label>Treatment Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 0 RSV F Vaccine 135µg/0.5mL Day 21 Phosphate Buffer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 0 Treatment / Formulation 1 Day 21 Phosphate Buffer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 0 Treatment / Formulation 1 Day 21 Treatment / Formulation 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group D</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 0 Treatment / Formulation 2 Day 21 Phosphate Buffer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group E</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 0 Treatment / Formulation 2 Day 21 Treatment / Formulation 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group F</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 0 Treatment / Formulation 3 Day 21 Phosphate Buffer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group G</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 0 Treatment / Formulation 3 Day 21 Treatment / Formulation 3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group H</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 0 Treatment / Formulation 4 Day 21 Phosphate Buffer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group J</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 0 Treatment / Formulation 4 Day 21 Treatment / Formulation 4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group K</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 0 Treatment / Formulation 5 Day 21 Phosphate Buffer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group L</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 0 Treatment / Formulation 5 Day 21 Treatment / Formulation 5</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group M</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Day 0 Phosphate Buffer Day 21 Phosphate Buffer</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RSV F Vaccine with Aluminum Phosphate Adjuvant</intervention_name>
    <arm_group_label>Treatment Group B</arm_group_label>
    <arm_group_label>Treatment Group C</arm_group_label>
    <arm_group_label>Treatment Group D</arm_group_label>
    <arm_group_label>Treatment Group E</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>RSV F Vaccine</intervention_name>
    <arm_group_label>Treatment Group A</arm_group_label>
    <arm_group_label>Treatment Group F</arm_group_label>
    <arm_group_label>Treatment Group G</arm_group_label>
    <arm_group_label>Treatment Group H</arm_group_label>
    <arm_group_label>Treatment Group J</arm_group_label>
    <arm_group_label>Treatment Group K</arm_group_label>
    <arm_group_label>Treatment Group L</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Matrix-M1 Adjuvant</intervention_name>
    <arm_group_label>Treatment Group F</arm_group_label>
    <arm_group_label>Treatment Group G</arm_group_label>
    <arm_group_label>Treatment Group H</arm_group_label>
    <arm_group_label>Treatment Group J</arm_group_label>
    <arm_group_label>Treatment Group K</arm_group_label>
    <arm_group_label>Treatment Group L</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Phosphate Buffer</intervention_name>
    <arm_group_label>Treatment Group A</arm_group_label>
    <arm_group_label>Treatment Group B</arm_group_label>
    <arm_group_label>Treatment Group D</arm_group_label>
    <arm_group_label>Treatment Group F</arm_group_label>
    <arm_group_label>Treatment Group H</arm_group_label>
    <arm_group_label>Treatment Group K</arm_group_label>
    <arm_group_label>Treatment Group M</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females 60 through 80 years of age who are ambulatory and live in the&#xD;
             community or in an assisted-living facility that provides minimal assistance, such&#xD;
             that the subject is primarily responsible for self-care and activities of daily&#xD;
             living. Subjects may have one or more chronic medical diagnoses, but should be&#xD;
             clinically stable as assessed by:&#xD;
&#xD;
               -  Absence of changes in medical therapy within one month due to treatment failure&#xD;
                  or toxicity (dose adjustments of ongoing therapies for optimal effect, or&#xD;
                  replacements within a class of drugs due to convenience or cost, will be deemed&#xD;
                  acceptable),&#xD;
&#xD;
               -  Absence of medical events qualifying as SAEs within one month of the planned&#xD;
                  vaccination on Day 0, and&#xD;
&#xD;
               -  Absence of known, current, and life-limiting diagnoses which, in the opinion of&#xD;
                  the investigator, render survival to completion of the protocol unlikely.&#xD;
&#xD;
          2. Willing and able (on both a physical and cognitive basis) to give informed consent&#xD;
             prior to study enrollment. To complete the consent process, all qualifying subjects&#xD;
             will correctly answer at least 4 out of 5 questions of the informed consent form (ICF)&#xD;
             comprehension assessment in no more than 2 attempts.&#xD;
&#xD;
          3. Able to comply with study requirements. As the protocol procedures involve telephone&#xD;
             contacts for safety ascertainment, eligible subjects must have a reliable access to a&#xD;
             telephone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Received any prior RSV vaccine.&#xD;
&#xD;
          2. Participation in research involving any additional investigational product (drug /&#xD;
             biologic / device) within 45 days before planned date of first vaccination.&#xD;
&#xD;
          3. History of a serious reaction to any prior vaccination or a history of Guillain-Barré&#xD;
             syndrome (GBS) within 6 weeks of any prior influenza immunization.&#xD;
&#xD;
          4. Receipt of inactivated influenza vaccine within 14 days prior to the Day 0 dose of&#xD;
             test article or any other vaccine within the 4 weeks prior to the Day 0 dose of test&#xD;
             article.&#xD;
&#xD;
          5. Any known or suspected immunosuppressive condition, acquired or congenital, as&#xD;
             determined by history and/or physical examination.&#xD;
&#xD;
          6. Chronic administration (defined as more than 14 continuous days) of immunosuppressants&#xD;
             or other immune-modifying drugs within 6 months prior to the administration of the&#xD;
             study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a&#xD;
             systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical,&#xD;
             inhaled, and nasal glucocorticoids will be permitted.&#xD;
&#xD;
          7. Administration of immunoglobulins and/or any blood products within the 3 months&#xD;
             preceding the administration of the study vaccine or during the study.&#xD;
&#xD;
          8. Acute disease at the time of enrollment (defined as the presence of a moderate or&#xD;
             severe illness with or without fever, or an oral temperature ≥ 38.0°C on the planned&#xD;
             day of vaccine administration).&#xD;
&#xD;
          9. Known disturbance of coagulation. Potential subjects receiving aspirin, clopidogrel,&#xD;
             prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban, or warfarin under good&#xD;
             control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or&#xD;
             stroke in the setting of atrial fibrillation will NOT be excluded.&#xD;
&#xD;
         10. Suspicion or recent history (within one year of planned vaccination) of alcohol or&#xD;
             other substance abuse.&#xD;
&#xD;
         11. Any condition that in the opinion of the investigator would pose a health risk to the&#xD;
             subject if enrolled or could interfere with evaluation of the vaccine or&#xD;
             interpretation of study results (including neurologic, cognitive, or psychiatric&#xD;
             conditions deemed likely to impair the quality of study compliance or safety&#xD;
             reporting).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Development</last_name>
    <role>Study Director</role>
    <affiliation>Novavax</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site AU004</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site AU005</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4006</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site AU002</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>50000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site AU006</name>
      <address>
        <city>Prahran</city>
        <state>Victoria</state>
        <zip>3181</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Resarch Site AU001</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>December 2, 2021</last_update_submitted>
  <last_update_submitted_qc>December 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RSV</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aluminum phosphate</mesh_term>
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03026348
org study id: RSV-E-205
nct id: NCT03026348
lead sponsor: 
has dmc: No
This is a randomized, observer-blind, trial in clinically-stable older adults. Up to 300
      eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into
      multiple dose/formulation treatment arms. Safety and immunogenicity data through Day 56 will
      be used to select a vaccine candidate to potentially evaluate in a Part 2 study. Proportions
      of subjects in various strata will not be pre-specified and the goal will be to achieve an
      approximately equal distribution of subjects with these characteristics across the treatment
      groups. Serology measures consistent with the study outcomes will be reported.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Neutralizing antibody titers to at least one RSV/A strain
time frame: Day 0, 21, 28
measure: Subjects with solicited local and systemic AEs occurring within the 7-day period following dosings on Day 0 and Day 21 and all adverse events, solicited and unsolicited, occurring within the 56-day period of Day 0.
time frame: Day 0 - Day 6, Day 21 - Day 27; Day 0 - Day 56
measure: Serum concentrations of antibodies competitive with palivizumab (i.e., PCA) for binding to the RSV F protein.
time frame: Day 0, 21, 28, 56, 119, 385
measure: Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.
time frame: Day 0, 21, 28, 56, 119, 385
measure: Counts of IFN-γ spot forming units following in vitro stimulation of Day 0, Day 7, and Day 28 PBMC isolates with RSV F peptides.
time frame: Day 0, 7, 28
measure: Counts and proportions of Day 0, Day 7, and Day 28 peripheral blood T cells positive by intracellular staining for IL-2, IFN-γ, or TNF-α production (alone or any combination thereof) following in vitro stimulation with RSV F peptides.
time frame: Day 0, 7, 28
arm group label: Treatment Group A
arm group type: Active Comparator
description: Day 0 RSV F Vaccine 135µg/0.5mL Day 21 Phosphate Buffer
arm group label: Treatment Group B
arm group type: Active Comparator
description: Day 0 Treatment / Formulation 1 Day 21 Phosphate Buffer
arm group label: Treatment Group C
arm group type: Active Comparator
description: Day 0 Treatment / Formulation 1 Day 21 Treatment / Formulation 1
arm group label: Treatment Group D
arm group type: Active Comparator
description: Day 0 Treatment / Formulation 2 Day 21 Phosphate Buffer
arm group label: Treatment Group E
arm group type: Active Comparator
description: Day 0 Treatment / Formulation 2 Day 21 Treatment / Formulation 2
arm group label: Treatment Group F
arm group type: Active Comparator
description: Day 0 Treatment / Formulation 3 Day 21 Phosphate Buffer
arm group label: Treatment Group G
arm group type: Active Comparator
description: Day 0 Treatment / Formulation 3 Day 21 Treatment / Formulation 3
arm group label: Treatment Group H
arm group type: Active Comparator
description: Day 0 Treatment / Formulation 4 Day 21 Phosphate Buffer
arm group label: Treatment Group J
arm group type: Active Comparator
description: Day 0 Treatment / Formulation 4 Day 21 Treatment / Formulation 4
arm group label: Treatment Group K
arm group type: Active Comparator
description: Day 0 Treatment / Formulation 5 Day 21 Phosphate Buffer
arm group label: Treatment Group L
arm group type: Active Comparator
description: Day 0 Treatment / Formulation 5 Day 21 Treatment / Formulation 5
arm group label: Treatment Group M
arm group type: Placebo Comparator
description: Day 0 Phosphate Buffer Day 21 Phosphate Buffer
intervention type: Biological
intervention name: RSV F Vaccine with Aluminum Phosphate Adjuvant
arm group label: Treatment Group B
arm group label: Treatment Group C
arm group label: Treatment Group D
arm group label: Treatment Group E
intervention type: Biological
intervention name: RSV F Vaccine
arm group label: Treatment Group A
arm group label: Treatment Group F
arm group label: Treatment Group G
arm group label: Treatment Group H
arm group label: Treatment Group J
arm group label: Treatment Group K
arm group label: Treatment Group L
intervention type: Biological
intervention name: Matrix-M1 Adjuvant
arm group label: Treatment Group F
arm group label: Treatment Group G
arm group label: Treatment Group H
arm group label: Treatment Group J
arm group label: Treatment Group K
arm group label: Treatment Group L
intervention type: Other
intervention name: Phosphate Buffer
arm group label: Treatment Group A
arm group label: Treatment Group B
arm group label: Treatment Group D
arm group label: Treatment Group F
arm group label: Treatment Group H
arm group label: Treatment Group K
arm group label: Treatment Group M
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Development
role: Study Director
affiliation: Novavax
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Aluminum phosphate
mesh term: Vaccines
sharing ipd: Undecided